Improving Skin Pigmentation and Texture with the Fractional 1550 nm Laser
By Jeffrey S. Dover, M.D., F.R.C.P.C., Murad Alam, M.D., and Zakia Rahman, M.D.
We’ve had much success in treating epidermal pigmentation, melasma, and rhytides, as well as textural abnormalities, including acne-related and surgical scars, with fractional resurfacing using the Fraxel laser (Reliant technologies). (Two other devices were released this summer: Palomar’s Lux1540, an Er:YAG-based device, and Cynosure’s Affirm 1440 nm, which is an Nd:YAG-based device. Other devices are coming.)
The Fraxel is a 30-watt, diode-pumped, 1550-nm erbium fiber laser that targets water as its chromophore. With fractional resurfacing, deep microthermal zones (70 to 100 µm wide, 250 to 800 µm deep) of tissue coagulation are produced. Tissue is not vaporized; the stratum corneum remains intact. The epidermal coagulated tissue is expelled and replaced by keratinocyte migration. Upon significant damage to the basement membrane zone, dermal contents are also expelled as microscopic epidermal and dermal necrotic debris (MENDs). In this way, epidermal and dermal pigmentation are treated without specifically targeting melanin as the chromophore. Zones of collagen denaturation in the dermis trigger the inflammatory cascade, which leads to collagen remodeling and new collagen formation.
The Fraxel SR 1500, a second-generation Fraxel device, is now available commercially, and it has a telescopic lens with variable spot size (smaller as well as larger) at varying energies.
Fractional laser treatment may be used to resurface any nonfacial part of the body, but is particularly useful on the neck, chest and hands. For selected applications, fractional laser treatment may have greater efficacy than some other non-ablative modalities with similar downtime.
Since November 2003, the Fraxel laser has received several FDA-approved indications. The first was for coagulation of soft tissue; other indications include treatment of periorbital rhytides, pigmented lesions, melasma, skin resurfacing, acne scars and surgical scars.
At this point, 2 years of clinical data and studies are available with this device, and this information has enabled us to optimize treatment parameters and improve patient outcomes. Here are tips on treating some specific conditions with the Fraxel. Review the table for more detailed parameters.
Photodamage, including pigmentation and rhytides. A greater number of “gentler” treatments (five or six) with less downtime are required to achieve the same cumulative results as fewer (perhaps three) “high-level” treatments, which entail greater down time. The probability of achieving 100% tissue coverage is far greater with five 20% treatments as opposed to 10 10% treatments.
Scars (acne and surgical). Higher-energy treatments obtain better results when compared to lower-energy treatments. At equal surface area coverage of 20%, a 20 mJ/cm2 treatment treats twice the volume of tissue as a 10 mJ/cm2 treatment. This explains the greater efficacy seen for deep rhytides and acne scars with higher-energy treatments.
Melasma. Results in treating this condition are encouraging. Before treatment, patients should be placed on a bleaching regimen and must practice strict sun avoidance and use high-SPF sunscreens. Retinoids should be stopped 1 week prior to treatment because they can interfere with rapid re-epithelialization.
Ideally, patients should be treated monthly at low energies of 6 to 8 mJ/cm2 at 1000-2000 MTZ/cm2. Three to six total treatments with a “touch-up” at 6 months is commonly prescribed, but not always necessary. Post-inflammatory changes, particularly in patients who have hyperactive melano-cytes, may occur; however, in our experience these changes are usually more homogeneous and better tolerated by patients than the mottled, uneven pigmentation of melasma. Melasma can recur, particularly when the causative melanocytes and hormonal profile are present.
Pain management. This is one of the most significant hurdles of the procedure. Discomfort from the laser treatment is managed by use of topical anesthetic prior to procedure and forced cool air during the procedure.
Post-treatment edema and possible hyperpigmentation. Some patients have little swelling; the average patient experiences 1 to 3 days, and less than 5% of patients swell for up to a week.
Studies indicate an approximately 10% to 12% overall incidence of hyperpigmentation after fractional treatments. Hyperpigmentation is uncommon in patients with light skin types (I and II).
* This piece is modified from a manuscript in press in the Skin Therapy Letter.
Dr. Dover is a Director of SkinCare Physicians in Chestnut Hill, MA. He is Associate Clinical Professor of Dermatology at Yale University School of Medicine. He is also Adjunct Professor of Medicine (Dermatology) at Dartmouth Medical School.
Dr. Alam is Chief of the Section of Cutaneous and Aesthetic Surgery, Department of Dermatology, Northwestern University in Chicago.
Dr. Rahman is Clinical Instructor of Dermatology (Affiliated) at Stanford School of Medicine. In addition, she’s Assistant Chief of Dermatology, PAVAHCS, Livermore Division.
Disclosures: Drs. Dover and Alam have no financial disclosures that are relevant to the subject matter discussed. Dr. Rahman is a consultant to Reliant Technologies.
The New “Face” of Dermal Fillers — the Hands
By Ranella J. Hirsch, M.D., F.A.A.D.
Excessive sun exposure along with the loss of subcutaneous tissue creates the appearance of aged, sagging skin that is a hallmark of cutaneous aging. While typically most pronounced on the face, the aesthetic dermatologist is now frequently called upon to treat far beyond the face in support of full-body rejuvenation. Favored areas include the neck, décolleté and hands.
Because our hands receive so much exposure in day-to-day communication, it is one of the first places to start showing signs of aging. Common visible signs include pigmented lentigos, precancerous growths, and the loss of fatty tissue leaving an unpleasant bony or string-like appearance. Multiple new technologies are now available to treat both of the aging hallmarks — a variety of laser and light therapies or topical options for the dyschromias, as well as subcutaneous tissue augmentation with injectable fillers and fat for volume restoration.
Until recently, hand rejuvenation due to volume loss was limited by the relative high price for limited duration of effect. Recently, there have been a large number of new products and developments. Hyaluronic acid is a glycosaminoglycan polysaccharide composed of alternating residues of the monosaccharides d-glucuronic acid and N-acetyl-d-glucosamine forming a linear polysaccharide chain.
Glycosamino-glycans are abundant in fetal skin and are present in low levels in adulthood. Poly-L-lactic acid is also able to replace volume in this site. An excellent older technique for replacement of volume in the hands utilizes autologous fat.
In most instances, anesthesia prior to injection consists of the application of topical medications or ice. In our experience, topical anesthetics are all that are necessary, and the procedure is one of minimal discomfort. Usual precautions regarding the pretreatment reduction of purpura apply (avoidance of NSAIDS, aspirin, and herbal procoagulant substances.)
Our preferred technique when injecting hyaluron fillers is 1 cc of Restylane in the subcutaneous “dead” space on the back of each hand between the extensor tendons, utilizing one or two puncture points slightly distal to the flexion line of the wrist. We deliver 0.1-ml aliquots and then massage distally with firm pressure using the injector’s thumbs. In our experience, the application of hand cream on the injector’s gloved hands allows for a more comfortable experience for the patient during vigorous massage. Correct placement of the needle bevel in the superficial dermis is vital to avoid deep injections into the vessels that prevail in this anatomic location.
Hand rejuvenation is a minimal downtime; high-satisfaction procedure that represents what we believe is the next wave in full-body rejuvenation.
Dr. Hirsch is Director of Skincare Doctors in Cambridge, MA, where she is a cosmetic dermatologist and laser surgeon. She is Vice President of the American Society of Cosmetic Dermatology and Aesthetic Surgery.
Disclosure: Dr. Hirsch is a researcher/clinical investigator for Candela, Palomar, ConBio, Cynosure, and Allergan. She has also received honoraria from Medicis.
Photopneumatic Therapy: A Novel Approach for Treating Acne Vulgaris
By Vic Narurkar, M.D.
Photopneumatic therapy (PPx) (Aesthera PPx System) manipulates the optical characteristics of the skin by momentarily stretching it by 25% to 35%. Melanin and hemoglobin concentration is temporarily reduced, which results in greater transmission of light to dermal targets.
Optical manipulation of the skin increases the efficiency of lower wavelength photons in the 400-nm to 500-nm range, which have better absorption of desired chromophores. This allows for safer and less painful treatment of dermal targets.
This therapy has been shown in a single-blinded clinical study to be effective for long-term hair reduction. A coincidental observation during the initial clinical trial for PPx was the improvement of moderate inflammatory acne vulgaris.
This was most evident when the treatments had to be halted for FDA clearance of long-term hair reduction. Patients universally noted a resurgence of acne lesions during this time.
This led to a multicenter study (Narurkar, Shamban, Enkobiri and Jitsukawa, Lasers Surg Med, Supp, April 2006) to study the safety and efficacy of PPx for acne vulgaris, an indication that is currently pending FDA clearance.
PPx’s mechanism lifts the sebaceous gland bringing it closer to the skin surface, and vacuum activation through a precision coupler results in opening and inverting the sebaceous gland. Congested sebum is ejected, resulting in the consequent cleansing of the pore.
These lower-wavelength photons are optimal for the absorption spectrum of Propionibacterium acnes bacteria while simultaneous sebaceous gland modification results in longer-term maintenance of clearance.
The single-blinded multicenter study demonstrated 71% of treated patients who had previously not responded to any other topical, oral or laser treatment of acne showed improvement with photopneumatic therapy. Treatments were painless and completed in less than 10 minutes. The immediate impact, speed of treatment and lack of discomfort resulted in a greater degree of patient satisfaction and compliance.
While a multitude of laser and light sources have been shown to improve acne, patient and physician acceptance have been poor due to pain, compliance, cost and length of time needed to implement treatments.
The second phase of the study involves the efficacy in conjunction with 5-aminolevulinic acid (ALA), and preliminary results indicate greater activation compared with other broadband light devices and lasers, due to optimal absorption in the 400-nm to 500-nm range.
PPx offers a novel, safe and effective treatment for moderate inflammatory acne vulgaris.
Increased patient comfort, speed of treatment and simultaneous aesthetic effects of pore cleansing produce greater patient acceptance and compliance.
Dr. Narurkar is Associate Professor of Dermatology at the University of California in Davis, CA.
Disclosure: Dr. Narurkar received funding from Aesthera Corp. in order to conduct clinical trials. In addition, he’s a member of Aesthera’s medical advisory board.
Plasma Skin Regeneration: Worthy of a Seat at the Rejuvenation Table
By Kenneth Arndt, M.D.
The emergence of a new, unique, and effective tool to the dermatologist’s armamentarium is always exciting. One of the latest innovations is the use of thermal energy delivered in the form of millisecond pulses of a plasma — ionized nitrogen — that can successfully treat mild to severe photodamage and induce skin regeneration.
The Portrait system, an FDA-approved device, delivers gradations of heat to the skin but does not depend upon a chromophore within tissue for absorption.
Use of the system has many appealing features. It can be used after topical anesthesia only, will diminish or eliminate the dyspigmentation of superficial photodamage and diminish fine lines and deeper rhytides and scars, and it can be used to treat a single cosmetic unit or the entire face in a 5- to 20-minute procedure. It also induces skin tightening. Downtime is approximately 2 to 3 days after a lower-energy treatment, and a week or more after a more intense treatment, after which period desquamation occurs.
The procedure is not ablative in that no tissue is blown off or vaporized, and there is no oozing or crusting. The injured epidermis stays in place and acts as its own dressing, beneath which there is re-epithelialization and connective tissue regeneration. Neocollagenesis is seen at considerable depths within the dermis, and this process continues for up to a year after treatment.
Plasma skin regeneration now has a legitimate seat at the table when considering the numerous ablative and non-ablative resurfacing techniques available for the treatment of photodamage and other skin textural abnormalities.
Dr. Arndt is a Director of SkinCare Physicians in Chestnut Hill, MA. He is also Clinical Professor of Dermatology at Yale and Harvard Medical Schools, and Adjunct Professor of Medicine at Dartmouth Medical School.
Disclosure: Dr. Arndt has no conflict of interest with any of the subject matter discussed here.
Recent Developments with Radiofrequency Tissue Tightening
By Michael Kaminer, M.D.
Over the last 12 months, several significant advances in tissue tightening with monopolar radiofrequency (ThermaCool, Thermage) have enabled us to perform this procedure faster and with less pain.
Most notably, the 3-cm2 treatment tip was introduced. With this tip, physicians are able to perform treatments approximately 30% faster than previously. In addition, this new tip has reduced the pain associated with the procedure, and appears to have significantly improved the results that one can obtain with treatment. By producing improved results in less time with less pain, patient satisfaction has increased considerably over the past 12 months. In fact, a soon to be published multicenter study reveals a success rate with Thermage in 94% of treated patients. This is a considerably more predictable efficacy rate than in the past.
The treatment algorithm has also evolved over the past 12 months, firmly supporting the notion that multiple passes (as many as 8 to10), at low fluences and titrated to pain is the optimum way to deploy monopolar radiofrequency. Pain perception is kept to a maximum of five or six on a 10-point scale, which enables patients to have their procedure done with minimal sedation and/or analgesia. A total of approximately 500 pulses are used to treat the lower face and forehead in one treatment session. Results are usually seen, at least to some extent, immediately at the time of treatment. Patients continue to see a progression of improvement for 6 months after treatment, and some patients report that they improve for as many as 12 months.
Treatment settings with the new 3-cm2 tip are usually in the 354 to 355 range for the first three or four passes. Reducing the settings with subsequent passes to as low as 353 sometimes is optimum to keep patient comfort at the 5 out of 10 scale. In some patients who develop significant erythema with treatment, lower settings are needed.
The optimum patient who is likely to respond appears to be both men and women, who have medium-thickness and quality skin, with a small to moderate amount of subcutaneous fat. Those patients who have extremely thin faces and only cutaneous laxity in some cases do not respond as well as one might hope. Conversely, extremely heavy patients with round full faces sometimes do not obtain as much improvement as they might like. However, some of the best results seen with Thermage treatments are sometimes in those patients who have larger faces, indicating that sometimes it is difficult to predict exactly who will be the best candidates for treatment.
Recently, Thermage has received FDA clearance to treat body parts. Areas that have been treated include the upper arms, inner thighs, knees, outer thighs, and abdomen. The home run appears to be skin tightening in the periumbilical region. The classic candidate would be a woman in her 30s or 40s, who has had children. Often, these women will have a moderate amount of skin laxity, but not a significant amount of subcutaneous fat. In these women, a single treatment with between 600 and 900 pulses using the 3-cm2 tip can produce dramatic improvement in the absence of surgery. Although stretchmarks do not directly improve with treatment, it does appear that tightening of the skin of the lower abdomen can diminish their visibility, as well as significantly improving the tone, texture, and contour of the abdominal area.
In some patients, the abdomen is more sensitive than the skin on the face, and lower treatment settings are needed. There are reports that in some patients, cellulite can be diminished when treating areas of the legs. Some patients are delighted with the improvement of the contour and cellulite of their legs, but this can be difficult to document photographically. For this reason, peer-reviewed clinical trials will be needed to determine if indeed monopolar radiofrequency treatments with Thermage can improve cellulite.
The most recent addition to the treatment arsenal of Thermage is the 0.25-cm2 treatment tip for use on the upper and lower eyelids. Much of the clinical research for this tip was performed by our ophthalmology colleague, Dr. Brian Biesman.
Early reports and data suggest that treatment of eyelid skin with Thermage can produce a modest yet predictable tightening and improvement. Clearly, this will be an exciting area to watch in the coming months to see how tightening of eyelid skin in the absence of surgery evolves.
There is now a broad consensus among many physicians from multiple specialties that the concept of tissue tightening using monopolar radiofrequency (Thermage) has been proven to be a viable technology. Many physicians have published studies that support the reliability, safety, and predictability of tissue tightening utilizing this novel radiofrequency device.
Over the past year, there have been many exciting developments, including scientific data that show 94% of patients improve with treatment of the face, two new treatment tips, FDA approval to treat areas on the body, as well as validation of a safe, minimally painful, effective algorithm and treatment strategy.
Dr. Kaminer is a Director of SkinCare Physicians in Chestnut Hill, MA. He is Assistant Clinical Professor of Dermatology at Yale Medical School and an Adjunct Professor of Medicine (Dermatology) at Dartmouth Medical School.
Disclosure: Dr. Kaminer is on the Scientific Advisory Board of Thermage and has conducted clinical research sponsored by Thermage.
ALA-PDT: Another Stellar Year
By Michael H. Gold, M.D.
Aminolevulinic acid and photodynamic therapy (ALA-PDT) has had another stellar year of acceptance from the dermatologic community. Physicians have come to realize that there are several wonderful uses for ALA-PDT, and our knowledge base for this type of therapy has continued to grow.
Presently, ALA-PDT in the United States is FDA approved for 20% 5-aminolevulinic acid (Levulan Kerastick), utilizing a 14- to 18-hour drug incubation and a blue light source, for the treatment of nonhyperkeratotic AKs of the face and scalp. A second drug, the methyl ester of ALA, Metvix (in Europe) or Metvixia (in the United States) has FDA clearance for the treatment of nonhyperkeratotic AKs of the face using a red light source with 3 hours of drug incubation under occlusion. We can expect Metvixia to appear in this country sometime in 2007.
Published peer-reviewed clinical trials have shown that ALA-PDT can be successfully used with a different method than that cleared by the FDA. Routinely, ALA is used as a short-contact, full-face procedure. The short contact is usually around 1 hour. Also, besides blue light, research has shown that both intense pulsed light devices and pulsed dye lasers can be successfully used for PDT. Studies clearly show that utilizing this short-contact technique, AKs are easily treated, as are the signs associated with photodamage, i.e., photorejuvenation. Five published split-face trials have confirmed earlier studies that suggested this type of therapy for AKs and photorejuvenation.
As well, published peer-reviewed trials have confirmed that ALA-PDT is a useful therapeutic approach for moderate to severe inflammatory acne vulgaris. At least 10 clinical trials are published in our literature as well as two split-face clinical trials confirming the effectiveness of ALA-PDT in acne vulgaris. Further-more, Phase II clinical trials are planned to further the acne vulgaris work. A second paper showing the effectiveness of ALA-PDT in the treatment of hidradeni-tis suppurativa has also appeared in the literature.
In Europe, Metvix continues to be a real player for nonmelanoma skin cancers and AKs. New clinical information with regard to photorejuvenation and acne vulgaris is beginning to emerge from well-run clinical investigations. Metvix will have a role in the U.S. market; however, this is not yet fully determined.
One of the major concerns for ALA-PDT in the U.S. market continues to be the compounding of ALA and not using the proprietary product on the market at this time. As physicians, we are violating the “use” patent for this drug. More importantly, to save a few dollars, we are risking the continued support of a company that has been very good to dermatology. They support us, they support our meetings and societies, and we should support them. Besides, it’s the law.
Finally, ALA-PDT is a therapy that is here to stay. We need to have commitments to continue clinical trials and work through protocols and initiatives that will bring this therapy to the next level. Our patients deserve this.
Dr. Gold is Director of the Gold Skin Care Center and Tennessee Clinical Research Center in Nashville. He’s also Assistant Clinical Professor at Vanderbilt University Medical School and Vanderbilt University Nursing School, both in Nashville.
Disclosure: Dr. Gold is a consultant, advisory board and speakers’ program member, performs research, owns stock, and receives honoraria from Dusa Pharmaceuticals.
Radiesse for Helical Rim Depressed Scars
By Joel L. Cohen, M.D.
I have had success using Radiesse for correcting depressed scars along helical rim in patients who have undergone Mohs surgery and full-thickness skin grafts.
In the 67-year-old man depicted below, I used 0.3 cc of Radiesse, which I placed along depressed area of the scar.
Placement of Radiesse along the perichondrium can result in a nice correction with durability of about 10 to 12 months for depressed ear or nasal scars such as those seen after reconstruction of skin cancer defects — particularly along the helical rim.
To perform this procedure, I pinch the patient’s ear with my non-injecting hand. Then, I inject the product in a retrograde fashion along the depressed scar using a 27-g needle (1 1/4 inch) and a linear threading technique. Next, I mold and shape the product to restore an even contour along the helical rim. Placing small aliquots of product to residual depressed areas can then be performed with a serial puncture technique.
Subcision with an 18-g NoKor needle can separate the adhesions in cases where creating a plane is difficult — though this significantly increases the degree of bruising and swelling post-procedure. In addition, the holes in the skin from this large subcision needle usually results in some extrusion of filler during the Radiesse injections.
Dr. Cohen is Director of AboutSkin Dermatology and DermSurgery in Englewood, CO. His practice focuses on Mohs surgery and cosmetic dermatology. He is President of the Colorado Dermatologic Society, Chair of the ASDS Patient Education Committee, and on the Board of Directors of the American Society of Cosmetic Dermatology and Aesthetic Surgery.
Disclosure: Dr. Cohen has been a consultant and a clinical trial participant for Radiesse.
Improving Skin Pigmentation and Texture with the Fractional 1550 nm Laser
By Jeffrey S. Dover, M.D., F.R.C.P.C., Murad Alam, M.D., and Zakia Rahman, M.D.
We’ve had much success in treating epidermal pigmentation, melasma, and rhytides, as well as textural abnormalities, including acne-related and surgical scars, with fractional resurfacing using the Fraxel laser (Reliant technologies). (Two other devices were released this summer: Palomar’s Lux1540, an Er:YAG-based device, and Cynosure’s Affirm 1440 nm, which is an Nd:YAG-based device. Other devices are coming.)
The Fraxel is a 30-watt, diode-pumped, 1550-nm erbium fiber laser that targets water as its chromophore. With fractional resurfacing, deep microthermal zones (70 to 100 µm wide, 250 to 800 µm deep) of tissue coagulation are produced. Tissue is not vaporized; the stratum corneum remains intact. The epidermal coagulated tissue is expelled and replaced by keratinocyte migration. Upon significant damage to the basement membrane zone, dermal contents are also expelled as microscopic epidermal and dermal necrotic debris (MENDs). In this way, epidermal and dermal pigmentation are treated without specifically targeting melanin as the chromophore. Zones of collagen denaturation in the dermis trigger the inflammatory cascade, which leads to collagen remodeling and new collagen formation.
The Fraxel SR 1500, a second-generation Fraxel device, is now available commercially, and it has a telescopic lens with variable spot size (smaller as well as larger) at varying energies.
Fractional laser treatment may be used to resurface any nonfacial part of the body, but is particularly useful on the neck, chest and hands. For selected applications, fractional laser treatment may have greater efficacy than some other non-ablative modalities with similar downtime.
Since November 2003, the Fraxel laser has received several FDA-approved indications. The first was for coagulation of soft tissue; other indications include treatment of periorbital rhytides, pigmented lesions, melasma, skin resurfacing, acne scars and surgical scars.
At this point, 2 years of clinical data and studies are available with this device, and this information has enabled us to optimize treatment parameters and improve patient outcomes. Here are tips on treating some specific conditions with the Fraxel. Review the table for more detailed parameters.
Photodamage, including pigmentation and rhytides. A greater number of “gentler” treatments (five or six) with less downtime are required to achieve the same cumulative results as fewer (perhaps three) “high-level” treatments, which entail greater down time. The probability of achieving 100% tissue coverage is far greater with five 20% treatments as opposed to 10 10% treatments.
Scars (acne and surgical). Higher-energy treatments obtain better results when compared to lower-energy treatments. At equal surface area coverage of 20%, a 20 mJ/cm2 treatment treats twice the volume of tissue as a 10 mJ/cm2 treatment. This explains the greater efficacy seen for deep rhytides and acne scars with higher-energy treatments.
Melasma. Results in treating this condition are encouraging. Before treatment, patients should be placed on a bleaching regimen and must practice strict sun avoidance and use high-SPF sunscreens. Retinoids should be stopped 1 week prior to treatment because they can interfere with rapid re-epithelialization.
Ideally, patients should be treated monthly at low energies of 6 to 8 mJ/cm2 at 1000-2000 MTZ/cm2. Three to six total treatments with a “touch-up” at 6 months is commonly prescribed, but not always necessary. Post-inflammatory changes, particularly in patients who have hyperactive melano-cytes, may occur; however, in our experience these changes are usually more homogeneous and better tolerated by patients than the mottled, uneven pigmentation of melasma. Melasma can recur, particularly when the causative melanocytes and hormonal profile are present.
Pain management. This is one of the most significant hurdles of the procedure. Discomfort from the laser treatment is managed by use of topical anesthetic prior to procedure and forced cool air during the procedure.
Post-treatment edema and possible hyperpigmentation. Some patients have little swelling; the average patient experiences 1 to 3 days, and less than 5% of patients swell for up to a week.
Studies indicate an approximately 10% to 12% overall incidence of hyperpigmentation after fractional treatments. Hyperpigmentation is uncommon in patients with light skin types (I and II).
* This piece is modified from a manuscript in press in the Skin Therapy Letter.
Dr. Dover is a Director of SkinCare Physicians in Chestnut Hill, MA. He is Associate Clinical Professor of Dermatology at Yale University School of Medicine. He is also Adjunct Professor of Medicine (Dermatology) at Dartmouth Medical School.
Dr. Alam is Chief of the Section of Cutaneous and Aesthetic Surgery, Department of Dermatology, Northwestern University in Chicago.
Dr. Rahman is Clinical Instructor of Dermatology (Affiliated) at Stanford School of Medicine. In addition, she’s Assistant Chief of Dermatology, PAVAHCS, Livermore Division.
Disclosures: Drs. Dover and Alam have no financial disclosures that are relevant to the subject matter discussed. Dr. Rahman is a consultant to Reliant Technologies.
The New “Face” of Dermal Fillers — the Hands
By Ranella J. Hirsch, M.D., F.A.A.D.
Excessive sun exposure along with the loss of subcutaneous tissue creates the appearance of aged, sagging skin that is a hallmark of cutaneous aging. While typically most pronounced on the face, the aesthetic dermatologist is now frequently called upon to treat far beyond the face in support of full-body rejuvenation. Favored areas include the neck, décolleté and hands.
Because our hands receive so much exposure in day-to-day communication, it is one of the first places to start showing signs of aging. Common visible signs include pigmented lentigos, precancerous growths, and the loss of fatty tissue leaving an unpleasant bony or string-like appearance. Multiple new technologies are now available to treat both of the aging hallmarks — a variety of laser and light therapies or topical options for the dyschromias, as well as subcutaneous tissue augmentation with injectable fillers and fat for volume restoration.
Until recently, hand rejuvenation due to volume loss was limited by the relative high price for limited duration of effect. Recently, there have been a large number of new products and developments. Hyaluronic acid is a glycosaminoglycan polysaccharide composed of alternating residues of the monosaccharides d-glucuronic acid and N-acetyl-d-glucosamine forming a linear polysaccharide chain.
Glycosamino-glycans are abundant in fetal skin and are present in low levels in adulthood. Poly-L-lactic acid is also able to replace volume in this site. An excellent older technique for replacement of volume in the hands utilizes autologous fat.
In most instances, anesthesia prior to injection consists of the application of topical medications or ice. In our experience, topical anesthetics are all that are necessary, and the procedure is one of minimal discomfort. Usual precautions regarding the pretreatment reduction of purpura apply (avoidance of NSAIDS, aspirin, and herbal procoagulant substances.)
Our preferred technique when injecting hyaluron fillers is 1 cc of Restylane in the subcutaneous “dead” space on the back of each hand between the extensor tendons, utilizing one or two puncture points slightly distal to the flexion line of the wrist. We deliver 0.1-ml aliquots and then massage distally with firm pressure using the injector’s thumbs. In our experience, the application of hand cream on the injector’s gloved hands allows for a more comfortable experience for the patient during vigorous massage. Correct placement of the needle bevel in the superficial dermis is vital to avoid deep injections into the vessels that prevail in this anatomic location.
Hand rejuvenation is a minimal downtime; high-satisfaction procedure that represents what we believe is the next wave in full-body rejuvenation.
Dr. Hirsch is Director of Skincare Doctors in Cambridge, MA, where she is a cosmetic dermatologist and laser surgeon. She is Vice President of the American Society of Cosmetic Dermatology and Aesthetic Surgery.
Disclosure: Dr. Hirsch is a researcher/clinical investigator for Candela, Palomar, ConBio, Cynosure, and Allergan. She has also received honoraria from Medicis.
Photopneumatic Therapy: A Novel Approach for Treating Acne Vulgaris
By Vic Narurkar, M.D.
Photopneumatic therapy (PPx) (Aesthera PPx System) manipulates the optical characteristics of the skin by momentarily stretching it by 25% to 35%. Melanin and hemoglobin concentration is temporarily reduced, which results in greater transmission of light to dermal targets.
Optical manipulation of the skin increases the efficiency of lower wavelength photons in the 400-nm to 500-nm range, which have better absorption of desired chromophores. This allows for safer and less painful treatment of dermal targets.
This therapy has been shown in a single-blinded clinical study to be effective for long-term hair reduction. A coincidental observation during the initial clinical trial for PPx was the improvement of moderate inflammatory acne vulgaris.
This was most evident when the treatments had to be halted for FDA clearance of long-term hair reduction. Patients universally noted a resurgence of acne lesions during this time.
This led to a multicenter study (Narurkar, Shamban, Enkobiri and Jitsukawa, Lasers Surg Med, Supp, April 2006) to study the safety and efficacy of PPx for acne vulgaris, an indication that is currently pending FDA clearance.
PPx’s mechanism lifts the sebaceous gland bringing it closer to the skin surface, and vacuum activation through a precision coupler results in opening and inverting the sebaceous gland. Congested sebum is ejected, resulting in the consequent cleansing of the pore.
These lower-wavelength photons are optimal for the absorption spectrum of Propionibacterium acnes bacteria while simultaneous sebaceous gland modification results in longer-term maintenance of clearance.
The single-blinded multicenter study demonstrated 71% of treated patients who had previously not responded to any other topical, oral or laser treatment of acne showed improvement with photopneumatic therapy. Treatments were painless and completed in less than 10 minutes. The immediate impact, speed of treatment and lack of discomfort resulted in a greater degree of patient satisfaction and compliance.
While a multitude of laser and light sources have been shown to improve acne, patient and physician acceptance have been poor due to pain, compliance, cost and length of time needed to implement treatments.
The second phase of the study involves the efficacy in conjunction with 5-aminolevulinic acid (ALA), and preliminary results indicate greater activation compared with other broadband light devices and lasers, due to optimal absorption in the 400-nm to 500-nm range.
PPx offers a novel, safe and effective treatment for moderate inflammatory acne vulgaris.
Increased patient comfort, speed of treatment and simultaneous aesthetic effects of pore cleansing produce greater patient acceptance and compliance.
Dr. Narurkar is Associate Professor of Dermatology at the University of California in Davis, CA.
Disclosure: Dr. Narurkar received funding from Aesthera Corp. in order to conduct clinical trials. In addition, he’s a member of Aesthera’s medical advisory board.
Plasma Skin Regeneration: Worthy of a Seat at the Rejuvenation Table
By Kenneth Arndt, M.D.
The emergence of a new, unique, and effective tool to the dermatologist’s armamentarium is always exciting. One of the latest innovations is the use of thermal energy delivered in the form of millisecond pulses of a plasma — ionized nitrogen — that can successfully treat mild to severe photodamage and induce skin regeneration.
The Portrait system, an FDA-approved device, delivers gradations of heat to the skin but does not depend upon a chromophore within tissue for absorption.
Use of the system has many appealing features. It can be used after topical anesthesia only, will diminish or eliminate the dyspigmentation of superficial photodamage and diminish fine lines and deeper rhytides and scars, and it can be used to treat a single cosmetic unit or the entire face in a 5- to 20-minute procedure. It also induces skin tightening. Downtime is approximately 2 to 3 days after a lower-energy treatment, and a week or more after a more intense treatment, after which period desquamation occurs.
The procedure is not ablative in that no tissue is blown off or vaporized, and there is no oozing or crusting. The injured epidermis stays in place and acts as its own dressing, beneath which there is re-epithelialization and connective tissue regeneration. Neocollagenesis is seen at considerable depths within the dermis, and this process continues for up to a year after treatment.
Plasma skin regeneration now has a legitimate seat at the table when considering the numerous ablative and non-ablative resurfacing techniques available for the treatment of photodamage and other skin textural abnormalities.
Dr. Arndt is a Director of SkinCare Physicians in Chestnut Hill, MA. He is also Clinical Professor of Dermatology at Yale and Harvard Medical Schools, and Adjunct Professor of Medicine at Dartmouth Medical School.
Disclosure: Dr. Arndt has no conflict of interest with any of the subject matter discussed here.
Recent Developments with Radiofrequency Tissue Tightening
By Michael Kaminer, M.D.
Over the last 12 months, several significant advances in tissue tightening with monopolar radiofrequency (ThermaCool, Thermage) have enabled us to perform this procedure faster and with less pain.
Most notably, the 3-cm2 treatment tip was introduced. With this tip, physicians are able to perform treatments approximately 30% faster than previously. In addition, this new tip has reduced the pain associated with the procedure, and appears to have significantly improved the results that one can obtain with treatment. By producing improved results in less time with less pain, patient satisfaction has increased considerably over the past 12 months. In fact, a soon to be published multicenter study reveals a success rate with Thermage in 94% of treated patients. This is a considerably more predictable efficacy rate than in the past.
The treatment algorithm has also evolved over the past 12 months, firmly supporting the notion that multiple passes (as many as 8 to10), at low fluences and titrated to pain is the optimum way to deploy monopolar radiofrequency. Pain perception is kept to a maximum of five or six on a 10-point scale, which enables patients to have their procedure done with minimal sedation and/or analgesia. A total of approximately 500 pulses are used to treat the lower face and forehead in one treatment session. Results are usually seen, at least to some extent, immediately at the time of treatment. Patients continue to see a progression of improvement for 6 months after treatment, and some patients report that they improve for as many as 12 months.
Treatment settings with the new 3-cm2 tip are usually in the 354 to 355 range for the first three or four passes. Reducing the settings with subsequent passes to as low as 353 sometimes is optimum to keep patient comfort at the 5 out of 10 scale. In some patients who develop significant erythema with treatment, lower settings are needed.
The optimum patient who is likely to respond appears to be both men and women, who have medium-thickness and quality skin, with a small to moderate amount of subcutaneous fat. Those patients who have extremely thin faces and only cutaneous laxity in some cases do not respond as well as one might hope. Conversely, extremely heavy patients with round full faces sometimes do not obtain as much improvement as they might like. However, some of the best results seen with Thermage treatments are sometimes in those patients who have larger faces, indicating that sometimes it is difficult to predict exactly who will be the best candidates for treatment.
Recently, Thermage has received FDA clearance to treat body parts. Areas that have been treated include the upper arms, inner thighs, knees, outer thighs, and abdomen. The home run appears to be skin tightening in the periumbilical region. The classic candidate would be a woman in her 30s or 40s, who has had children. Often, these women will have a moderate amount of skin laxity, but not a significant amount of subcutaneous fat. In these women, a single treatment with between 600 and 900 pulses using the 3-cm2 tip can produce dramatic improvement in the absence of surgery. Although stretchmarks do not directly improve with treatment, it does appear that tightening of the skin of the lower abdomen can diminish their visibility, as well as significantly improving the tone, texture, and contour of the abdominal area.
In some patients, the abdomen is more sensitive than the skin on the face, and lower treatment settings are needed. There are reports that in some patients, cellulite can be diminished when treating areas of the legs. Some patients are delighted with the improvement of the contour and cellulite of their legs, but this can be difficult to document photographically. For this reason, peer-reviewed clinical trials will be needed to determine if indeed monopolar radiofrequency treatments with Thermage can improve cellulite.
The most recent addition to the treatment arsenal of Thermage is the 0.25-cm2 treatment tip for use on the upper and lower eyelids. Much of the clinical research for this tip was performed by our ophthalmology colleague, Dr. Brian Biesman.
Early reports and data suggest that treatment of eyelid skin with Thermage can produce a modest yet predictable tightening and improvement. Clearly, this will be an exciting area to watch in the coming months to see how tightening of eyelid skin in the absence of surgery evolves.
There is now a broad consensus among many physicians from multiple specialties that the concept of tissue tightening using monopolar radiofrequency (Thermage) has been proven to be a viable technology. Many physicians have published studies that support the reliability, safety, and predictability of tissue tightening utilizing this novel radiofrequency device.
Over the past year, there have been many exciting developments, including scientific data that show 94% of patients improve with treatment of the face, two new treatment tips, FDA approval to treat areas on the body, as well as validation of a safe, minimally painful, effective algorithm and treatment strategy.
Dr. Kaminer is a Director of SkinCare Physicians in Chestnut Hill, MA. He is Assistant Clinical Professor of Dermatology at Yale Medical School and an Adjunct Professor of Medicine (Dermatology) at Dartmouth Medical School.
Disclosure: Dr. Kaminer is on the Scientific Advisory Board of Thermage and has conducted clinical research sponsored by Thermage.
ALA-PDT: Another Stellar Year
By Michael H. Gold, M.D.
Aminolevulinic acid and photodynamic therapy (ALA-PDT) has had another stellar year of acceptance from the dermatologic community. Physicians have come to realize that there are several wonderful uses for ALA-PDT, and our knowledge base for this type of therapy has continued to grow.
Presently, ALA-PDT in the United States is FDA approved for 20% 5-aminolevulinic acid (Levulan Kerastick), utilizing a 14- to 18-hour drug incubation and a blue light source, for the treatment of nonhyperkeratotic AKs of the face and scalp. A second drug, the methyl ester of ALA, Metvix (in Europe) or Metvixia (in the United States) has FDA clearance for the treatment of nonhyperkeratotic AKs of the face using a red light source with 3 hours of drug incubation under occlusion. We can expect Metvixia to appear in this country sometime in 2007.
Published peer-reviewed clinical trials have shown that ALA-PDT can be successfully used with a different method than that cleared by the FDA. Routinely, ALA is used as a short-contact, full-face procedure. The short contact is usually around 1 hour. Also, besides blue light, research has shown that both intense pulsed light devices and pulsed dye lasers can be successfully used for PDT. Studies clearly show that utilizing this short-contact technique, AKs are easily treated, as are the signs associated with photodamage, i.e., photorejuvenation. Five published split-face trials have confirmed earlier studies that suggested this type of therapy for AKs and photorejuvenation.
As well, published peer-reviewed trials have confirmed that ALA-PDT is a useful therapeutic approach for moderate to severe inflammatory acne vulgaris. At least 10 clinical trials are published in our literature as well as two split-face clinical trials confirming the effectiveness of ALA-PDT in acne vulgaris. Further-more, Phase II clinical trials are planned to further the acne vulgaris work. A second paper showing the effectiveness of ALA-PDT in the treatment of hidradeni-tis suppurativa has also appeared in the literature.
In Europe, Metvix continues to be a real player for nonmelanoma skin cancers and AKs. New clinical information with regard to photorejuvenation and acne vulgaris is beginning to emerge from well-run clinical investigations. Metvix will have a role in the U.S. market; however, this is not yet fully determined.
One of the major concerns for ALA-PDT in the U.S. market continues to be the compounding of ALA and not using the proprietary product on the market at this time. As physicians, we are violating the “use” patent for this drug. More importantly, to save a few dollars, we are risking the continued support of a company that has been very good to dermatology. They support us, they support our meetings and societies, and we should support them. Besides, it’s the law.
Finally, ALA-PDT is a therapy that is here to stay. We need to have commitments to continue clinical trials and work through protocols and initiatives that will bring this therapy to the next level. Our patients deserve this.
Dr. Gold is Director of the Gold Skin Care Center and Tennessee Clinical Research Center in Nashville. He’s also Assistant Clinical Professor at Vanderbilt University Medical School and Vanderbilt University Nursing School, both in Nashville.
Disclosure: Dr. Gold is a consultant, advisory board and speakers’ program member, performs research, owns stock, and receives honoraria from Dusa Pharmaceuticals.
Radiesse for Helical Rim Depressed Scars
By Joel L. Cohen, M.D.
I have had success using Radiesse for correcting depressed scars along helical rim in patients who have undergone Mohs surgery and full-thickness skin grafts.
In the 67-year-old man depicted below, I used 0.3 cc of Radiesse, which I placed along depressed area of the scar.
Placement of Radiesse along the perichondrium can result in a nice correction with durability of about 10 to 12 months for depressed ear or nasal scars such as those seen after reconstruction of skin cancer defects — particularly along the helical rim.
To perform this procedure, I pinch the patient’s ear with my non-injecting hand. Then, I inject the product in a retrograde fashion along the depressed scar using a 27-g needle (1 1/4 inch) and a linear threading technique. Next, I mold and shape the product to restore an even contour along the helical rim. Placing small aliquots of product to residual depressed areas can then be performed with a serial puncture technique.
Subcision with an 18-g NoKor needle can separate the adhesions in cases where creating a plane is difficult — though this significantly increases the degree of bruising and swelling post-procedure. In addition, the holes in the skin from this large subcision needle usually results in some extrusion of filler during the Radiesse injections.
Dr. Cohen is Director of AboutSkin Dermatology and DermSurgery in Englewood, CO. His practice focuses on Mohs surgery and cosmetic dermatology. He is President of the Colorado Dermatologic Society, Chair of the ASDS Patient Education Committee, and on the Board of Directors of the American Society of Cosmetic Dermatology and Aesthetic Surgery.
Disclosure: Dr. Cohen has been a consultant and a clinical trial participant for Radiesse.
Improving Skin Pigmentation and Texture with the Fractional 1550 nm Laser
By Jeffrey S. Dover, M.D., F.R.C.P.C., Murad Alam, M.D., and Zakia Rahman, M.D.
We’ve had much success in treating epidermal pigmentation, melasma, and rhytides, as well as textural abnormalities, including acne-related and surgical scars, with fractional resurfacing using the Fraxel laser (Reliant technologies). (Two other devices were released this summer: Palomar’s Lux1540, an Er:YAG-based device, and Cynosure’s Affirm 1440 nm, which is an Nd:YAG-based device. Other devices are coming.)
The Fraxel is a 30-watt, diode-pumped, 1550-nm erbium fiber laser that targets water as its chromophore. With fractional resurfacing, deep microthermal zones (70 to 100 µm wide, 250 to 800 µm deep) of tissue coagulation are produced. Tissue is not vaporized; the stratum corneum remains intact. The epidermal coagulated tissue is expelled and replaced by keratinocyte migration. Upon significant damage to the basement membrane zone, dermal contents are also expelled as microscopic epidermal and dermal necrotic debris (MENDs). In this way, epidermal and dermal pigmentation are treated without specifically targeting melanin as the chromophore. Zones of collagen denaturation in the dermis trigger the inflammatory cascade, which leads to collagen remodeling and new collagen formation.
The Fraxel SR 1500, a second-generation Fraxel device, is now available commercially, and it has a telescopic lens with variable spot size (smaller as well as larger) at varying energies.
Fractional laser treatment may be used to resurface any nonfacial part of the body, but is particularly useful on the neck, chest and hands. For selected applications, fractional laser treatment may have greater efficacy than some other non-ablative modalities with similar downtime.
Since November 2003, the Fraxel laser has received several FDA-approved indications. The first was for coagulation of soft tissue; other indications include treatment of periorbital rhytides, pigmented lesions, melasma, skin resurfacing, acne scars and surgical scars.
At this point, 2 years of clinical data and studies are available with this device, and this information has enabled us to optimize treatment parameters and improve patient outcomes. Here are tips on treating some specific conditions with the Fraxel. Review the table for more detailed parameters.
Photodamage, including pigmentation and rhytides. A greater number of “gentler” treatments (five or six) with less downtime are required to achieve the same cumulative results as fewer (perhaps three) “high-level” treatments, which entail greater down time. The probability of achieving 100% tissue coverage is far greater with five 20% treatments as opposed to 10 10% treatments.
Scars (acne and surgical). Higher-energy treatments obtain better results when compared to lower-energy treatments. At equal surface area coverage of 20%, a 20 mJ/cm2 treatment treats twice the volume of tissue as a 10 mJ/cm2 treatment. This explains the greater efficacy seen for deep rhytides and acne scars with higher-energy treatments.
Melasma. Results in treating this condition are encouraging. Before treatment, patients should be placed on a bleaching regimen and must practice strict sun avoidance and use high-SPF sunscreens. Retinoids should be stopped 1 week prior to treatment because they can interfere with rapid re-epithelialization.
Ideally, patients should be treated monthly at low energies of 6 to 8 mJ/cm2 at 1000-2000 MTZ/cm2. Three to six total treatments with a “touch-up” at 6 months is commonly prescribed, but not always necessary. Post-inflammatory changes, particularly in patients who have hyperactive melano-cytes, may occur; however, in our experience these changes are usually more homogeneous and better tolerated by patients than the mottled, uneven pigmentation of melasma. Melasma can recur, particularly when the causative melanocytes and hormonal profile are present.
Pain management. This is one of the most significant hurdles of the procedure. Discomfort from the laser treatment is managed by use of topical anesthetic prior to procedure and forced cool air during the procedure.
Post-treatment edema and possible hyperpigmentation. Some patients have little swelling; the average patient experiences 1 to 3 days, and less than 5% of patients swell for up to a week.
Studies indicate an approximately 10% to 12% overall incidence of hyperpigmentation after fractional treatments. Hyperpigmentation is uncommon in patients with light skin types (I and II).
* This piece is modified from a manuscript in press in the Skin Therapy Letter.
Dr. Dover is a Director of SkinCare Physicians in Chestnut Hill, MA. He is Associate Clinical Professor of Dermatology at Yale University School of Medicine. He is also Adjunct Professor of Medicine (Dermatology) at Dartmouth Medical School.
Dr. Alam is Chief of the Section of Cutaneous and Aesthetic Surgery, Department of Dermatology, Northwestern University in Chicago.
Dr. Rahman is Clinical Instructor of Dermatology (Affiliated) at Stanford School of Medicine. In addition, she’s Assistant Chief of Dermatology, PAVAHCS, Livermore Division.
Disclosures: Drs. Dover and Alam have no financial disclosures that are relevant to the subject matter discussed. Dr. Rahman is a consultant to Reliant Technologies.
The New “Face” of Dermal Fillers — the Hands
By Ranella J. Hirsch, M.D., F.A.A.D.
Excessive sun exposure along with the loss of subcutaneous tissue creates the appearance of aged, sagging skin that is a hallmark of cutaneous aging. While typically most pronounced on the face, the aesthetic dermatologist is now frequently called upon to treat far beyond the face in support of full-body rejuvenation. Favored areas include the neck, décolleté and hands.
Because our hands receive so much exposure in day-to-day communication, it is one of the first places to start showing signs of aging. Common visible signs include pigmented lentigos, precancerous growths, and the loss of fatty tissue leaving an unpleasant bony or string-like appearance. Multiple new technologies are now available to treat both of the aging hallmarks — a variety of laser and light therapies or topical options for the dyschromias, as well as subcutaneous tissue augmentation with injectable fillers and fat for volume restoration.
Until recently, hand rejuvenation due to volume loss was limited by the relative high price for limited duration of effect. Recently, there have been a large number of new products and developments. Hyaluronic acid is a glycosaminoglycan polysaccharide composed of alternating residues of the monosaccharides d-glucuronic acid and N-acetyl-d-glucosamine forming a linear polysaccharide chain.
Glycosamino-glycans are abundant in fetal skin and are present in low levels in adulthood. Poly-L-lactic acid is also able to replace volume in this site. An excellent older technique for replacement of volume in the hands utilizes autologous fat.
In most instances, anesthesia prior to injection consists of the application of topical medications or ice. In our experience, topical anesthetics are all that are necessary, and the procedure is one of minimal discomfort. Usual precautions regarding the pretreatment reduction of purpura apply (avoidance of NSAIDS, aspirin, and herbal procoagulant substances.)
Our preferred technique when injecting hyaluron fillers is 1 cc of Restylane in the subcutaneous “dead” space on the back of each hand between the extensor tendons, utilizing one or two puncture points slightly distal to the flexion line of the wrist. We deliver 0.1-ml aliquots and then massage distally with firm pressure using the injector’s thumbs. In our experience, the application of hand cream on the injector’s gloved hands allows for a more comfortable experience for the patient during vigorous massage. Correct placement of the needle bevel in the superficial dermis is vital to avoid deep injections into the vessels that prevail in this anatomic location.
Hand rejuvenation is a minimal downtime; high-satisfaction procedure that represents what we believe is the next wave in full-body rejuvenation.
Dr. Hirsch is Director of Skincare Doctors in Cambridge, MA, where she is a cosmetic dermatologist and laser surgeon. She is Vice President of the American Society of Cosmetic Dermatology and Aesthetic Surgery.
Disclosure: Dr. Hirsch is a researcher/clinical investigator for Candela, Palomar, ConBio, Cynosure, and Allergan. She has also received honoraria from Medicis.
Photopneumatic Therapy: A Novel Approach for Treating Acne Vulgaris
By Vic Narurkar, M.D.
Photopneumatic therapy (PPx) (Aesthera PPx System) manipulates the optical characteristics of the skin by momentarily stretching it by 25% to 35%. Melanin and hemoglobin concentration is temporarily reduced, which results in greater transmission of light to dermal targets.
Optical manipulation of the skin increases the efficiency of lower wavelength photons in the 400-nm to 500-nm range, which have better absorption of desired chromophores. This allows for safer and less painful treatment of dermal targets.
This therapy has been shown in a single-blinded clinical study to be effective for long-term hair reduction. A coincidental observation during the initial clinical trial for PPx was the improvement of moderate inflammatory acne vulgaris.
This was most evident when the treatments had to be halted for FDA clearance of long-term hair reduction. Patients universally noted a resurgence of acne lesions during this time.
This led to a multicenter study (Narurkar, Shamban, Enkobiri and Jitsukawa, Lasers Surg Med, Supp, April 2006) to study the safety and efficacy of PPx for acne vulgaris, an indication that is currently pending FDA clearance.
PPx’s mechanism lifts the sebaceous gland bringing it closer to the skin surface, and vacuum activation through a precision coupler results in opening and inverting the sebaceous gland. Congested sebum is ejected, resulting in the consequent cleansing of the pore.
These lower-wavelength photons are optimal for the absorption spectrum of Propionibacterium acnes bacteria while simultaneous sebaceous gland modification results in longer-term maintenance of clearance.
The single-blinded multicenter study demonstrated 71% of treated patients who had previously not responded to any other topical, oral or laser treatment of acne showed improvement with photopneumatic therapy. Treatments were painless and completed in less than 10 minutes. The immediate impact, speed of treatment and lack of discomfort resulted in a greater degree of patient satisfaction and compliance.
While a multitude of laser and light sources have been shown to improve acne, patient and physician acceptance have been poor due to pain, compliance, cost and length of time needed to implement treatments.
The second phase of the study involves the efficacy in conjunction with 5-aminolevulinic acid (ALA), and preliminary results indicate greater activation compared with other broadband light devices and lasers, due to optimal absorption in the 400-nm to 500-nm range.
PPx offers a novel, safe and effective treatment for moderate inflammatory acne vulgaris.
Increased patient comfort, speed of treatment and simultaneous aesthetic effects of pore cleansing produce greater patient acceptance and compliance.
Dr. Narurkar is Associate Professor of Dermatology at the University of California in Davis, CA.
Disclosure: Dr. Narurkar received funding from Aesthera Corp. in order to conduct clinical trials. In addition, he’s a member of Aesthera’s medical advisory board.
Plasma Skin Regeneration: Worthy of a Seat at the Rejuvenation Table
By Kenneth Arndt, M.D.
The emergence of a new, unique, and effective tool to the dermatologist’s armamentarium is always exciting. One of the latest innovations is the use of thermal energy delivered in the form of millisecond pulses of a plasma — ionized nitrogen — that can successfully treat mild to severe photodamage and induce skin regeneration.
The Portrait system, an FDA-approved device, delivers gradations of heat to the skin but does not depend upon a chromophore within tissue for absorption.
Use of the system has many appealing features. It can be used after topical anesthesia only, will diminish or eliminate the dyspigmentation of superficial photodamage and diminish fine lines and deeper rhytides and scars, and it can be used to treat a single cosmetic unit or the entire face in a 5- to 20-minute procedure. It also induces skin tightening. Downtime is approximately 2 to 3 days after a lower-energy treatment, and a week or more after a more intense treatment, after which period desquamation occurs.
The procedure is not ablative in that no tissue is blown off or vaporized, and there is no oozing or crusting. The injured epidermis stays in place and acts as its own dressing, beneath which there is re-epithelialization and connective tissue regeneration. Neocollagenesis is seen at considerable depths within the dermis, and this process continues for up to a year after treatment.
Plasma skin regeneration now has a legitimate seat at the table when considering the numerous ablative and non-ablative resurfacing techniques available for the treatment of photodamage and other skin textural abnormalities.
Dr. Arndt is a Director of SkinCare Physicians in Chestnut Hill, MA. He is also Clinical Professor of Dermatology at Yale and Harvard Medical Schools, and Adjunct Professor of Medicine at Dartmouth Medical School.
Disclosure: Dr. Arndt has no conflict of interest with any of the subject matter discussed here.
Recent Developments with Radiofrequency Tissue Tightening
By Michael Kaminer, M.D.
Over the last 12 months, several significant advances in tissue tightening with monopolar radiofrequency (ThermaCool, Thermage) have enabled us to perform this procedure faster and with less pain.
Most notably, the 3-cm2 treatment tip was introduced. With this tip, physicians are able to perform treatments approximately 30% faster than previously. In addition, this new tip has reduced the pain associated with the procedure, and appears to have significantly improved the results that one can obtain with treatment. By producing improved results in less time with less pain, patient satisfaction has increased considerably over the past 12 months. In fact, a soon to be published multicenter study reveals a success rate with Thermage in 94% of treated patients. This is a considerably more predictable efficacy rate than in the past.
The treatment algorithm has also evolved over the past 12 months, firmly supporting the notion that multiple passes (as many as 8 to10), at low fluences and titrated to pain is the optimum way to deploy monopolar radiofrequency. Pain perception is kept to a maximum of five or six on a 10-point scale, which enables patients to have their procedure done with minimal sedation and/or analgesia. A total of approximately 500 pulses are used to treat the lower face and forehead in one treatment session. Results are usually seen, at least to some extent, immediately at the time of treatment. Patients continue to see a progression of improvement for 6 months after treatment, and some patients report that they improve for as many as 12 months.
Treatment settings with the new 3-cm2 tip are usually in the 354 to 355 range for the first three or four passes. Reducing the settings with subsequent passes to as low as 353 sometimes is optimum to keep patient comfort at the 5 out of 10 scale. In some patients who develop significant erythema with treatment, lower settings are needed.
The optimum patient who is likely to respond appears to be both men and women, who have medium-thickness and quality skin, with a small to moderate amount of subcutaneous fat. Those patients who have extremely thin faces and only cutaneous laxity in some cases do not respond as well as one might hope. Conversely, extremely heavy patients with round full faces sometimes do not obtain as much improvement as they might like. However, some of the best results seen with Thermage treatments are sometimes in those patients who have larger faces, indicating that sometimes it is difficult to predict exactly who will be the best candidates for treatment.
Recently, Thermage has received FDA clearance to treat body parts. Areas that have been treated include the upper arms, inner thighs, knees, outer thighs, and abdomen. The home run appears to be skin tightening in the periumbilical region. The classic candidate would be a woman in her 30s or 40s, who has had children. Often, these women will have a moderate amount of skin laxity, but not a significant amount of subcutaneous fat. In these women, a single treatment with between 600 and 900 pulses using the 3-cm2 tip can produce dramatic improvement in the absence of surgery. Although stretchmarks do not directly improve with treatment, it does appear that tightening of the skin of the lower abdomen can diminish their visibility, as well as significantly improving the tone, texture, and contour of the abdominal area.
In some patients, the abdomen is more sensitive than the skin on the face, and lower treatment settings are needed. There are reports that in some patients, cellulite can be diminished when treating areas of the legs. Some patients are delighted with the improvement of the contour and cellulite of their legs, but this can be difficult to document photographically. For this reason, peer-reviewed clinical trials will be needed to determine if indeed monopolar radiofrequency treatments with Thermage can improve cellulite.
The most recent addition to the treatment arsenal of Thermage is the 0.25-cm2 treatment tip for use on the upper and lower eyelids. Much of the clinical research for this tip was performed by our ophthalmology colleague, Dr. Brian Biesman.
Early reports and data suggest that treatment of eyelid skin with Thermage can produce a modest yet predictable tightening and improvement. Clearly, this will be an exciting area to watch in the coming months to see how tightening of eyelid skin in the absence of surgery evolves.
There is now a broad consensus among many physicians from multiple specialties that the concept of tissue tightening using monopolar radiofrequency (Thermage) has been proven to be a viable technology. Many physicians have published studies that support the reliability, safety, and predictability of tissue tightening utilizing this novel radiofrequency device.
Over the past year, there have been many exciting developments, including scientific data that show 94% of patients improve with treatment of the face, two new treatment tips, FDA approval to treat areas on the body, as well as validation of a safe, minimally painful, effective algorithm and treatment strategy.
Dr. Kaminer is a Director of SkinCare Physicians in Chestnut Hill, MA. He is Assistant Clinical Professor of Dermatology at Yale Medical School and an Adjunct Professor of Medicine (Dermatology) at Dartmouth Medical School.
Disclosure: Dr. Kaminer is on the Scientific Advisory Board of Thermage and has conducted clinical research sponsored by Thermage.
ALA-PDT: Another Stellar Year
By Michael H. Gold, M.D.
Aminolevulinic acid and photodynamic therapy (ALA-PDT) has had another stellar year of acceptance from the dermatologic community. Physicians have come to realize that there are several wonderful uses for ALA-PDT, and our knowledge base for this type of therapy has continued to grow.
Presently, ALA-PDT in the United States is FDA approved for 20% 5-aminolevulinic acid (Levulan Kerastick), utilizing a 14- to 18-hour drug incubation and a blue light source, for the treatment of nonhyperkeratotic AKs of the face and scalp. A second drug, the methyl ester of ALA, Metvix (in Europe) or Metvixia (in the United States) has FDA clearance for the treatment of nonhyperkeratotic AKs of the face using a red light source with 3 hours of drug incubation under occlusion. We can expect Metvixia to appear in this country sometime in 2007.
Published peer-reviewed clinical trials have shown that ALA-PDT can be successfully used with a different method than that cleared by the FDA. Routinely, ALA is used as a short-contact, full-face procedure. The short contact is usually around 1 hour. Also, besides blue light, research has shown that both intense pulsed light devices and pulsed dye lasers can be successfully used for PDT. Studies clearly show that utilizing this short-contact technique, AKs are easily treated, as are the signs associated with photodamage, i.e., photorejuvenation. Five published split-face trials have confirmed earlier studies that suggested this type of therapy for AKs and photorejuvenation.
As well, published peer-reviewed trials have confirmed that ALA-PDT is a useful therapeutic approach for moderate to severe inflammatory acne vulgaris. At least 10 clinical trials are published in our literature as well as two split-face clinical trials confirming the effectiveness of ALA-PDT in acne vulgaris. Further-more, Phase II clinical trials are planned to further the acne vulgaris work. A second paper showing the effectiveness of ALA-PDT in the treatment of hidradeni-tis suppurativa has also appeared in the literature.
In Europe, Metvix continues to be a real player for nonmelanoma skin cancers and AKs. New clinical information with regard to photorejuvenation and acne vulgaris is beginning to emerge from well-run clinical investigations. Metvix will have a role in the U.S. market; however, this is not yet fully determined.
One of the major concerns for ALA-PDT in the U.S. market continues to be the compounding of ALA and not using the proprietary product on the market at this time. As physicians, we are violating the “use” patent for this drug. More importantly, to save a few dollars, we are risking the continued support of a company that has been very good to dermatology. They support us, they support our meetings and societies, and we should support them. Besides, it’s the law.
Finally, ALA-PDT is a therapy that is here to stay. We need to have commitments to continue clinical trials and work through protocols and initiatives that will bring this therapy to the next level. Our patients deserve this.
Dr. Gold is Director of the Gold Skin Care Center and Tennessee Clinical Research Center in Nashville. He’s also Assistant Clinical Professor at Vanderbilt University Medical School and Vanderbilt University Nursing School, both in Nashville.
Disclosure: Dr. Gold is a consultant, advisory board and speakers’ program member, performs research, owns stock, and receives honoraria from Dusa Pharmaceuticals.
Radiesse for Helical Rim Depressed Scars
By Joel L. Cohen, M.D.
I have had success using Radiesse for correcting depressed scars along helical rim in patients who have undergone Mohs surgery and full-thickness skin grafts.
In the 67-year-old man depicted below, I used 0.3 cc of Radiesse, which I placed along depressed area of the scar.
Placement of Radiesse along the perichondrium can result in a nice correction with durability of about 10 to 12 months for depressed ear or nasal scars such as those seen after reconstruction of skin cancer defects — particularly along the helical rim.
To perform this procedure, I pinch the patient’s ear with my non-injecting hand. Then, I inject the product in a retrograde fashion along the depressed scar using a 27-g needle (1 1/4 inch) and a linear threading technique. Next, I mold and shape the product to restore an even contour along the helical rim. Placing small aliquots of product to residual depressed areas can then be performed with a serial puncture technique.
Subcision with an 18-g NoKor needle can separate the adhesions in cases where creating a plane is difficult — though this significantly increases the degree of bruising and swelling post-procedure. In addition, the holes in the skin from this large subcision needle usually results in some extrusion of filler during the Radiesse injections.
Dr. Cohen is Director of AboutSkin Dermatology and DermSurgery in Englewood, CO. His practice focuses on Mohs surgery and cosmetic dermatology. He is President of the Colorado Dermatologic Society, Chair of the ASDS Patient Education Committee, and on the Board of Directors of the American Society of Cosmetic Dermatology and Aesthetic Surgery.
Disclosure: Dr. Cohen has been a consultant and a clinical trial participant for Radiesse.
