A s the concept of non-surgical total facial restoration (NSTFR) continues to evolve in aesthetic dermatology, new products and procedures are shaping our menu of offerings. These new and continuously improving treatments expand our ability to not only restore damaged and aged skin, but also to rejuvenate the appearance to approximate a younger and healthier look. The challenge for aesthetic dermatologists, however, has been our limited ability to provide enhancing treatments, especially in a minimally invasive approach. Simply, we have lacked in our armamentarium the tools necessary to broadly alter the facial appearance in such a way as to provide durable (greater than 1 year), reproducible, malleable, and perhaps most importantly, correctable results in a non-surgical fashion. That is, until August of this year when the FDA approved poly-L-lactic acid (Sculptra) for the restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with HIV. Who’s Affected by Lipoatrophy Lipoatrophy as a phenotypic presentation of the facial appearance may arise from a multitude of factors including the inherent genetic expression of the aging process. Facial lipoatrophy may also be associated with the treatment of HIV with the highly active anti-retroviral treatments known as HAART therapy. While the exact mechanism of facial fat loss in HAART therapy remains unknown, its appearance is sudden, common and progressive. Even worse, the alteration in facial appearance can be a difficult to conceal “scarlet letter” of HIV infection, which in some individuals can lead to discontinuation of HAART therapy, with the resultant increased risk of progression of the disease. Facial lipoatrophy can also develop secondarily as a result of endurance exercise (long distance running), starvation/fad diets, diabetes, cancer, and genetically controlled (inherited) disorders of metabolism. Exploring Corrective Options Until recently, individuals with facial lipoatrophy were limited in options for correction. They could choose traditional invasive plastic surgery, perhaps with facial implants, fat transfer/grafting, silicone injections, or voluminous amounts of temporary (less than 1 year) dermal fillers such as collagen or hyaluronic acid. Clearly, none of these options were ideal, especially in the context of NSTFR (regardless of the motivation being restoration, rejuvenation or enhancement), where one approaches the aesthetic patient’s requests with a minimally invasive procedure list. The hallmark of which is characterized by a “low risk” and “high reward/satisfaction” profile. Ideally, these procedures are low in cost, low in “downtime” or recovery, low in risk of complications; they are also high in satisfaction, high in longevity, and high in “maintainability” or reproducibility, and highly (easily) correctable, if necessary. Again, in the context of NSTFR, there are standout procedures, such as Botox for the upper face; dermal fillers (collagen, hyalurons, and calcium hydroxyapitite) for the lower face/perioral region; a multitude of resurfacing options ranging from AHAs and retinoids through chemical peels, IPL with or without Levulan, and extending to CO2 laser resurfacing. Finally, there is maintenance with skincare products that at a minimum include the daily use of sunscreen. What has been missing (and sorely missed) from our checklist is the ability to shape or define, to correct, enhance or reduce in a broader sense the structural features of the face, especially the mid-face, so as to achieve a redefinition of the three-dimensional context of appearance, both concavity and convexity. Regardless of the motivation for alteration or correction, all patients enjoy certain facial proportions that from their perspective meet an ideal visage. For some it may be a sharpening of selected feature(s), for others perhaps a softening or contouring. For most, it means a reapportionment of ratios between areas of the face that re-approximates a healthy and youthful appearance. For many, this means a reduction in the concavity and a return to the convexity of the mid-face, a repair of deepening nasojugal, nasolabial, and mentolabial folds, lip enhancement, and re-establishing a sharp mandibular sweep with an appropriate cervico-mental angle. While there is no single agent that will perform all of these duties, our European colleagues have for the past 5 or more years been able to use poly-L-lactic acid, which is known as New-Fill outside the United States, for many of these aesthetic indications. Long Track Record of Success More than 150,000 patients have been treated outside the United States, principally for aesthetic concerns, with poly-L-lactic acid, or Sculptra as it is known in this country. The clinical responses of these patients have been reviewed and presented at essentially all major scientific and aesthetic meetings in the United States and abroad. The studies that have been performed have also been presented to the U.S. FDA as part of the approval process granted this summer. Clinical trials are ongoing for new indications, and perhaps most importantly, patients in this country have been able to enjoy the benefits of Sculptra for a variety of indications, both on and off label, for treatments including restoration, rejuvenation and enhancement. Additionally, some of the clinical experience gained with Sculptra has also been through its use in the repair and restoration of a normal facial appearance after Mohs surgery. Sculptra has been used post-surgically by the author (GLB) to repair soft tissue volume loss after extirpation of tumors in the mid-face region. Beginning 6 months post-repair, the depressed scar area(s) have been treated with a series of Sculptra injections at 3-week intervals to stimulate neocollagenesis. The results to date are very encouraging, and will be presented further in another format. Taking a Step-by-Step Approach The goal of this article is to share experience and knowledge gained from both clinical and trial use of poly-L-lactic acid, to assist the aesthetic dermatology practice in the rapid uptake and efficient use of Sculptra for the benefit of all aesthetic patients, including those who suffer from facial lipoatrophy of HIV infection and HAART therapy. Here, we’ll share six steps that we’ve found to be essential in attaining optimum outcomes with Sculptra. Step 1: Stress Patience Sculptra is an interesting product in that, in and of itself, Sculptra is not a dermal filler. In fact, Sculptra is not actually a filler at all, it is a biocompatible, biodegradable synthetic polymer akin to Vicryl suture. There is no requirement for pre-treatment skin testing. Sculptra is actually more of a “seed” or a catalyst that serves to stimulate the process of neocollagenesis in the areas where it is injected. The Sculptra that is injected is ultimately metabolized through non-enzymatic hydrolysis into glucose and CO2. The filling effect of dermal thickening is achieved through the process of native collagen formation, and this takes time (and patience)! When Sculptra is injected into an area, there is an immediate and transient volume correction secondary to the physical volume of the reconstituted product and tissue edema. The injection related volume resolves generally in 24 hours or less, leaving behind a paradoxical depression. Over the following weeks to months, there is a foreign body giant cell reaction as part of the tissue response, ultimately resolving in the production of collagen as the polymer degrades. Because of this delayed timeline of weeks to months, the full effects of Sculptra injections may take 3 to 6 months to develop. There will also be the need to do multiple injection sessions at 3- to 6-week intervals, with the average aesthetic patient requiring at least 3 injection sessions of a least one vial per session to achieve a complete response. Additionally, the total treatment benefit of Sculptra is not achieved in equal amounts with each injection; rather the results are “back-end loaded.” Proportionally more correction appears with the final treatment compared to the initial injection. Whether this is due the up-regulation of collagen synthesis over time, the effect of increasing amounts of the poly-L-lactic acid injected, or some other factor, is unknown at this time. What is important is the education to both the injector and patient to “be patient.” This timeline has several advantages for the novice injector, the primary one being results are achieved over time. This means the beginning injector has more room for error than with traditional fillers, as any irregularity of results stemming from injector inexperience may be compensated for on subsequent injection sessions. Step 2: Sign Consent Because Sculptra has a number of features (duration, cost, longevity, etc.) that differ from other dermal fillers, be sure to use an educational style consent form. Have the patient read, sign and take home a copy of the consent. This can serve to allay fears that the product is not working, or that it “disappeared” overnight. The consent can also serve as a gentle reminder that follow-up visits for multiple treatments are necessary to achieve optimal results. Ideally, the consent form will have multiple paragraphs where patients can initial to confirm that they have read the entire document. A sample consent form follows this article (available for download in PDF format). Sculptra users may wish to compare their existing consent to the sample and revise as necessary. As always, if there are any questions specific to your practice, consultation with your attorney and/or malpractice carrier is urged, and the sample consent is for educational purposes only and is not intended for patient use as a legal document. Step 3: take Photographs Because Sculptra therapy is a process which takes place over time, photographs taken before the procedure begins are an absolute must for every patient treated. Incremental results can be problematic as some patients may have less than ideal visual memories. The comparison of a baseline photograph can help reassure a patient partway through Sculptra therapy that improvement is indeed occurring. For the patient who has completed therapy, a before-and-after view can confirm results, guide follow-up treatments and serve as documentation in the medical record of treatment success. Also, with Sculptra the presence of photographs can help guide treatment decisions by comparing baseline and in-progress results to desired outcome, the final result may end up different than the initial intention. This is where the “artistic” component of Sculptra therapy plays a role, as the injector can literally “sculpt” the facial appearance one injection session at a time. For those offices that forget baseline photographs, simply have the patient return 1 or 2 days later after the injection, after the edema of the diluent (sterile water) has dissipated and the patient has returned to baseline. Finally, don’t forget to specifically obtain permission to take photographs! Step 4: Offer Packages Because Sculptra is a process that takes multiple injection sessions to achieve optimal correction, it is important to help the patient mentally obligate themselves. Think of Sculptra as a “fitness training program for the face,” and results take time. If the patient is not willing or able to complete the program, then the best results will never be obtained. By offering a package of treatment sessions, the full effect of the treatment program can be realized, and the patient is far less likely to stop partway through the recommended regimen. For most aesthetic patients, the package will be 1 vial of Sculptra per session, for 3 sessions, at 4-week intervals. Patients can purchase the package of three vials as one treatment program. If the patient needs less, a refund or credit toward other procedures can be given; if he or she needs more, then it is simple to sell additional treatments (vials). Consider offering a package discount to patients if they pay up front. This can be an incentive to commit to the full recommended treatment program, and helps to secure follow-up. The actual number of vials needed for any specific patient can only be estimated, as the clinical response is not completely predictable due to an individual patient’s variability in producing collagen after Sculptra injections. The amount of Sculptra used per treatment session is less of a variable than the total amount (number of treatment sessions) necessary to achieve full correction. This is a very important concept. The amount of Sculptra used per treatment session is relatively fixed, and is reflective of the surface area being treated, a two-dimensional effect. This is similar to the number of square feet of carpet needed to cover the floor of a room; it all depends on how big the room is, not how high the ceiling is. The amount of Sculptra needed per injection is reflective of how big the area being treated is, and how many areas are being treated each time — not how deep the areas are or how high you want to make them. Do not over-correct with Sculptra, use the fixed amount recommended per injection area (usually 0.1 ml to 0.2 ml) when using a 1/2-inch, 26-gauge needle in the tunneling or threading technique. If more correction is needed within a treated area, wait until the next treatment session. The degree of correction needed or desired, which is a 3-D effect, determines the number of treatments, not how much is used per treatment, which is fixed as above. Remember the TWA acronym: Treat – Wait – Assess. Step 5: Stay Deep The actual injection techniques used for Sculptra will vary based on the skills and experience of the injector, and the specific experience of the individual patient and his or her treatment areas. However, there are some general guidelines to help assure success and minimize complications. The most important concept is to remember that Sculptra is not a dermal filler, and as such, is not placed where one would typically inject a filler such as collagen or hyaluronic acid. Sculptra should be placed in the deep dermis or subcutaneously. European experience indicates that Sculptra can also be placed in the fat and muscle without complication. It does appear, however, that if Sculptra is placed too superficially in the dermis, or if not diluted sufficiently (5 ml per vial) that micro-nodules can form, leading to palpable or even visible elevations. Remember to stay deep and avoid complications. I also ask my patients to remember the 5-5-5 rule: gently massage the treated areas for 5 minutes, 5 times per day for 5 days post injection. If they have any problems remembering, I tell them to think of how many fingers they have on one hand. I personally like to use a 25-gauge needle, which is available in 5/8-, 1-, and 1.5-inch lengths. This gives me two advantages; the first is flexibility in tunneling or threading techniques, whereby using a longer needle, I am able to minimize percutaneous punctures and cover larger areas. The second is that the 25-gauge needle bore minimizes clogging during injections. Reconstituted Sculptra resembles a Kenalog suspension in its viscosity, and as such is prone to clogging. This is especially true if the product is not left to stand for at least 2 hours, although I prefer 12 to 18 hours as a minimum. Sculptra can be left standing for up to 72 hours after reconstitution as per FDA labeling. Regarding diluents, I always use 4 ml of sterile water for injection, and at the time of injection, I add 1 ml of 1% lidocaine (with or without epinephrine) to the vial for a total of 5 ml of diluent per vial. Additionally, leaving Sculptra in the vial rather than pre-filling syringes allows the injector to gently shake the product at the time of use to maintain the suspension. When holding the product in a syringe, keep a gentle rocking motion going to prevent clogging, and prior to each injection, gently pull back on the plunger to clear any sediment from the hub of the needle where clogging tends to occur. It also helps to inject quickly. If a clog does occur while injecting, gently pull back on the plunger to see if it will clear. If it doesn’t, then withdraw the needle from the patient and try clearing again. If the needle remains clogged, then exchange it for another, and try again. Step 6: Secure Comfort As with any injection, Sculptra can hurt, and with the multiple injections needed to complete a treatment session, pain can become a factor. There are a number of approaches that can be used including facial nerve blocks, topical anesthesia, talk-esthesia, chilling (both before and after injections), and others. The best approach is of course that which works best in your office, however, some general guidelines are as follows: • Sculptra injections are sub-dermal, this tissue plane is not as tender as intradermal injections. • Nerve blocks are usually not needed. • Topical anesthetic creams are very effective at dulling each needle puncture through the skin. • Also, remember to change your needle frequently to maintain a sharp point. • There is lidocaine in the reconstitution, which helps to develop a zone of anesthesia if used wisely. • Chilling the treatment areas both before and after can be very effective at not only reducing pain, but also in reducing bruising. • A smooth hand and a calm voice go a long way in reducing patients’ anxiety. Achieving Outstanding Results In summary, Sculptra as a tissue molding and collagen building product has become another valuable addition to our armamentarium of aesthetic treatments. It is capable of being much more than just another dermal filler, and in fact is highly compatible with dermal filling agents such as hyaluronic acids, where it can be used in conjunction to achieve outstanding clinical improvement. Sculptra joins a rapidly growing list of aesthetic products and procedures in NSTFR, where it enjoys a unique niche as a foundation for facial sculpting. Perhaps easier to use than traditional dermal fillers, Sculptra is very forgiving by its very nature of multiple treatment sessions, where each previous treatment is assessed prior to initiation of the next treatment. As with all new products and procedures, Sculptra has a learning curve that when closely examined appears quite negotiable. The most important take- away messages are not to overcorrect, inject deeply, wait and assess each treatment session, and properly educate your patients and staff. Following these general recommendations will help assure success with Sculptra in simple steps, and bring an entirely new approach for developing the best methods for NSTFR.
6 Simple Steps to Sculptra Success
A s the concept of non-surgical total facial restoration (NSTFR) continues to evolve in aesthetic dermatology, new products and procedures are shaping our menu of offerings. These new and continuously improving treatments expand our ability to not only restore damaged and aged skin, but also to rejuvenate the appearance to approximate a younger and healthier look. The challenge for aesthetic dermatologists, however, has been our limited ability to provide enhancing treatments, especially in a minimally invasive approach. Simply, we have lacked in our armamentarium the tools necessary to broadly alter the facial appearance in such a way as to provide durable (greater than 1 year), reproducible, malleable, and perhaps most importantly, correctable results in a non-surgical fashion. That is, until August of this year when the FDA approved poly-L-lactic acid (Sculptra) for the restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with HIV. Who’s Affected by Lipoatrophy Lipoatrophy as a phenotypic presentation of the facial appearance may arise from a multitude of factors including the inherent genetic expression of the aging process. Facial lipoatrophy may also be associated with the treatment of HIV with the highly active anti-retroviral treatments known as HAART therapy. While the exact mechanism of facial fat loss in HAART therapy remains unknown, its appearance is sudden, common and progressive. Even worse, the alteration in facial appearance can be a difficult to conceal “scarlet letter” of HIV infection, which in some individuals can lead to discontinuation of HAART therapy, with the resultant increased risk of progression of the disease. Facial lipoatrophy can also develop secondarily as a result of endurance exercise (long distance running), starvation/fad diets, diabetes, cancer, and genetically controlled (inherited) disorders of metabolism. Exploring Corrective Options Until recently, individuals with facial lipoatrophy were limited in options for correction. They could choose traditional invasive plastic surgery, perhaps with facial implants, fat transfer/grafting, silicone injections, or voluminous amounts of temporary (less than 1 year) dermal fillers such as collagen or hyaluronic acid. Clearly, none of these options were ideal, especially in the context of NSTFR (regardless of the motivation being restoration, rejuvenation or enhancement), where one approaches the aesthetic patient’s requests with a minimally invasive procedure list. The hallmark of which is characterized by a “low risk” and “high reward/satisfaction” profile. Ideally, these procedures are low in cost, low in “downtime” or recovery, low in risk of complications; they are also high in satisfaction, high in longevity, and high in “maintainability” or reproducibility, and highly (easily) correctable, if necessary. Again, in the context of NSTFR, there are standout procedures, such as Botox for the upper face; dermal fillers (collagen, hyalurons, and calcium hydroxyapitite) for the lower face/perioral region; a multitude of resurfacing options ranging from AHAs and retinoids through chemical peels, IPL with or without Levulan, and extending to CO2 laser resurfacing. Finally, there is maintenance with skincare products that at a minimum include the daily use of sunscreen. What has been missing (and sorely missed) from our checklist is the ability to shape or define, to correct, enhance or reduce in a broader sense the structural features of the face, especially the mid-face, so as to achieve a redefinition of the three-dimensional context of appearance, both concavity and convexity. Regardless of the motivation for alteration or correction, all patients enjoy certain facial proportions that from their perspective meet an ideal visage. For some it may be a sharpening of selected feature(s), for others perhaps a softening or contouring. For most, it means a reapportionment of ratios between areas of the face that re-approximates a healthy and youthful appearance. For many, this means a reduction in the concavity and a return to the convexity of the mid-face, a repair of deepening nasojugal, nasolabial, and mentolabial folds, lip enhancement, and re-establishing a sharp mandibular sweep with an appropriate cervico-mental angle. While there is no single agent that will perform all of these duties, our European colleagues have for the past 5 or more years been able to use poly-L-lactic acid, which is known as New-Fill outside the United States, for many of these aesthetic indications. Long Track Record of Success More than 150,000 patients have been treated outside the United States, principally for aesthetic concerns, with poly-L-lactic acid, or Sculptra as it is known in this country. The clinical responses of these patients have been reviewed and presented at essentially all major scientific and aesthetic meetings in the United States and abroad. The studies that have been performed have also been presented to the U.S. FDA as part of the approval process granted this summer. Clinical trials are ongoing for new indications, and perhaps most importantly, patients in this country have been able to enjoy the benefits of Sculptra for a variety of indications, both on and off label, for treatments including restoration, rejuvenation and enhancement. Additionally, some of the clinical experience gained with Sculptra has also been through its use in the repair and restoration of a normal facial appearance after Mohs surgery. Sculptra has been used post-surgically by the author (GLB) to repair soft tissue volume loss after extirpation of tumors in the mid-face region. Beginning 6 months post-repair, the depressed scar area(s) have been treated with a series of Sculptra injections at 3-week intervals to stimulate neocollagenesis. The results to date are very encouraging, and will be presented further in another format. Taking a Step-by-Step Approach The goal of this article is to share experience and knowledge gained from both clinical and trial use of poly-L-lactic acid, to assist the aesthetic dermatology practice in the rapid uptake and efficient use of Sculptra for the benefit of all aesthetic patients, including those who suffer from facial lipoatrophy of HIV infection and HAART therapy. Here, we’ll share six steps that we’ve found to be essential in attaining optimum outcomes with Sculptra. Step 1: Stress Patience Sculptra is an interesting product in that, in and of itself, Sculptra is not a dermal filler. In fact, Sculptra is not actually a filler at all, it is a biocompatible, biodegradable synthetic polymer akin to Vicryl suture. There is no requirement for pre-treatment skin testing. Sculptra is actually more of a “seed” or a catalyst that serves to stimulate the process of neocollagenesis in the areas where it is injected. The Sculptra that is injected is ultimately metabolized through non-enzymatic hydrolysis into glucose and CO2. The filling effect of dermal thickening is achieved through the process of native collagen formation, and this takes time (and patience)! When Sculptra is injected into an area, there is an immediate and transient volume correction secondary to the physical volume of the reconstituted product and tissue edema. The injection related volume resolves generally in 24 hours or less, leaving behind a paradoxical depression. Over the following weeks to months, there is a foreign body giant cell reaction as part of the tissue response, ultimately resolving in the production of collagen as the polymer degrades. Because of this delayed timeline of weeks to months, the full effects of Sculptra injections may take 3 to 6 months to develop. There will also be the need to do multiple injection sessions at 3- to 6-week intervals, with the average aesthetic patient requiring at least 3 injection sessions of a least one vial per session to achieve a complete response. Additionally, the total treatment benefit of Sculptra is not achieved in equal amounts with each injection; rather the results are “back-end loaded.” Proportionally more correction appears with the final treatment compared to the initial injection. Whether this is due the up-regulation of collagen synthesis over time, the effect of increasing amounts of the poly-L-lactic acid injected, or some other factor, is unknown at this time. What is important is the education to both the injector and patient to “be patient.” This timeline has several advantages for the novice injector, the primary one being results are achieved over time. This means the beginning injector has more room for error than with traditional fillers, as any irregularity of results stemming from injector inexperience may be compensated for on subsequent injection sessions. Step 2: Sign Consent Because Sculptra has a number of features (duration, cost, longevity, etc.) that differ from other dermal fillers, be sure to use an educational style consent form. Have the patient read, sign and take home a copy of the consent. This can serve to allay fears that the product is not working, or that it “disappeared” overnight. The consent can also serve as a gentle reminder that follow-up visits for multiple treatments are necessary to achieve optimal results. Ideally, the consent form will have multiple paragraphs where patients can initial to confirm that they have read the entire document. A sample consent form follows this article (available for download in PDF format). Sculptra users may wish to compare their existing consent to the sample and revise as necessary. As always, if there are any questions specific to your practice, consultation with your attorney and/or malpractice carrier is urged, and the sample consent is for educational purposes only and is not intended for patient use as a legal document. Step 3: take Photographs Because Sculptra therapy is a process which takes place over time, photographs taken before the procedure begins are an absolute must for every patient treated. Incremental results can be problematic as some patients may have less than ideal visual memories. The comparison of a baseline photograph can help reassure a patient partway through Sculptra therapy that improvement is indeed occurring. For the patient who has completed therapy, a before-and-after view can confirm results, guide follow-up treatments and serve as documentation in the medical record of treatment success. Also, with Sculptra the presence of photographs can help guide treatment decisions by comparing baseline and in-progress results to desired outcome, the final result may end up different than the initial intention. This is where the “artistic” component of Sculptra therapy plays a role, as the injector can literally “sculpt” the facial appearance one injection session at a time. For those offices that forget baseline photographs, simply have the patient return 1 or 2 days later after the injection, after the edema of the diluent (sterile water) has dissipated and the patient has returned to baseline. Finally, don’t forget to specifically obtain permission to take photographs! Step 4: Offer Packages Because Sculptra is a process that takes multiple injection sessions to achieve optimal correction, it is important to help the patient mentally obligate themselves. Think of Sculptra as a “fitness training program for the face,” and results take time. If the patient is not willing or able to complete the program, then the best results will never be obtained. By offering a package of treatment sessions, the full effect of the treatment program can be realized, and the patient is far less likely to stop partway through the recommended regimen. For most aesthetic patients, the package will be 1 vial of Sculptra per session, for 3 sessions, at 4-week intervals. Patients can purchase the package of three vials as one treatment program. If the patient needs less, a refund or credit toward other procedures can be given; if he or she needs more, then it is simple to sell additional treatments (vials). Consider offering a package discount to patients if they pay up front. This can be an incentive to commit to the full recommended treatment program, and helps to secure follow-up. The actual number of vials needed for any specific patient can only be estimated, as the clinical response is not completely predictable due to an individual patient’s variability in producing collagen after Sculptra injections. The amount of Sculptra used per treatment session is less of a variable than the total amount (number of treatment sessions) necessary to achieve full correction. This is a very important concept. The amount of Sculptra used per treatment session is relatively fixed, and is reflective of the surface area being treated, a two-dimensional effect. This is similar to the number of square feet of carpet needed to cover the floor of a room; it all depends on how big the room is, not how high the ceiling is. The amount of Sculptra needed per injection is reflective of how big the area being treated is, and how many areas are being treated each time — not how deep the areas are or how high you want to make them. Do not over-correct with Sculptra, use the fixed amount recommended per injection area (usually 0.1 ml to 0.2 ml) when using a 1/2-inch, 26-gauge needle in the tunneling or threading technique. If more correction is needed within a treated area, wait until the next treatment session. The degree of correction needed or desired, which is a 3-D effect, determines the number of treatments, not how much is used per treatment, which is fixed as above. Remember the TWA acronym: Treat – Wait – Assess. Step 5: Stay Deep The actual injection techniques used for Sculptra will vary based on the skills and experience of the injector, and the specific experience of the individual patient and his or her treatment areas. However, there are some general guidelines to help assure success and minimize complications. The most important concept is to remember that Sculptra is not a dermal filler, and as such, is not placed where one would typically inject a filler such as collagen or hyaluronic acid. Sculptra should be placed in the deep dermis or subcutaneously. European experience indicates that Sculptra can also be placed in the fat and muscle without complication. It does appear, however, that if Sculptra is placed too superficially in the dermis, or if not diluted sufficiently (5 ml per vial) that micro-nodules can form, leading to palpable or even visible elevations. Remember to stay deep and avoid complications. I also ask my patients to remember the 5-5-5 rule: gently massage the treated areas for 5 minutes, 5 times per day for 5 days post injection. If they have any problems remembering, I tell them to think of how many fingers they have on one hand. I personally like to use a 25-gauge needle, which is available in 5/8-, 1-, and 1.5-inch lengths. This gives me two advantages; the first is flexibility in tunneling or threading techniques, whereby using a longer needle, I am able to minimize percutaneous punctures and cover larger areas. The second is that the 25-gauge needle bore minimizes clogging during injections. Reconstituted Sculptra resembles a Kenalog suspension in its viscosity, and as such is prone to clogging. This is especially true if the product is not left to stand for at least 2 hours, although I prefer 12 to 18 hours as a minimum. Sculptra can be left standing for up to 72 hours after reconstitution as per FDA labeling. Regarding diluents, I always use 4 ml of sterile water for injection, and at the time of injection, I add 1 ml of 1% lidocaine (with or without epinephrine) to the vial for a total of 5 ml of diluent per vial. Additionally, leaving Sculptra in the vial rather than pre-filling syringes allows the injector to gently shake the product at the time of use to maintain the suspension. When holding the product in a syringe, keep a gentle rocking motion going to prevent clogging, and prior to each injection, gently pull back on the plunger to clear any sediment from the hub of the needle where clogging tends to occur. It also helps to inject quickly. If a clog does occur while injecting, gently pull back on the plunger to see if it will clear. If it doesn’t, then withdraw the needle from the patient and try clearing again. If the needle remains clogged, then exchange it for another, and try again. Step 6: Secure Comfort As with any injection, Sculptra can hurt, and with the multiple injections needed to complete a treatment session, pain can become a factor. There are a number of approaches that can be used including facial nerve blocks, topical anesthesia, talk-esthesia, chilling (both before and after injections), and others. The best approach is of course that which works best in your office, however, some general guidelines are as follows: • Sculptra injections are sub-dermal, this tissue plane is not as tender as intradermal injections. • Nerve blocks are usually not needed. • Topical anesthetic creams are very effective at dulling each needle puncture through the skin. • Also, remember to change your needle frequently to maintain a sharp point. • There is lidocaine in the reconstitution, which helps to develop a zone of anesthesia if used wisely. • Chilling the treatment areas both before and after can be very effective at not only reducing pain, but also in reducing bruising. • A smooth hand and a calm voice go a long way in reducing patients’ anxiety. Achieving Outstanding Results In summary, Sculptra as a tissue molding and collagen building product has become another valuable addition to our armamentarium of aesthetic treatments. It is capable of being much more than just another dermal filler, and in fact is highly compatible with dermal filling agents such as hyaluronic acids, where it can be used in conjunction to achieve outstanding clinical improvement. Sculptra joins a rapidly growing list of aesthetic products and procedures in NSTFR, where it enjoys a unique niche as a foundation for facial sculpting. Perhaps easier to use than traditional dermal fillers, Sculptra is very forgiving by its very nature of multiple treatment sessions, where each previous treatment is assessed prior to initiation of the next treatment. As with all new products and procedures, Sculptra has a learning curve that when closely examined appears quite negotiable. The most important take- away messages are not to overcorrect, inject deeply, wait and assess each treatment session, and properly educate your patients and staff. Following these general recommendations will help assure success with Sculptra in simple steps, and bring an entirely new approach for developing the best methods for NSTFR.
A s the concept of non-surgical total facial restoration (NSTFR) continues to evolve in aesthetic dermatology, new products and procedures are shaping our menu of offerings. These new and continuously improving treatments expand our ability to not only restore damaged and aged skin, but also to rejuvenate the appearance to approximate a younger and healthier look. The challenge for aesthetic dermatologists, however, has been our limited ability to provide enhancing treatments, especially in a minimally invasive approach. Simply, we have lacked in our armamentarium the tools necessary to broadly alter the facial appearance in such a way as to provide durable (greater than 1 year), reproducible, malleable, and perhaps most importantly, correctable results in a non-surgical fashion. That is, until August of this year when the FDA approved poly-L-lactic acid (Sculptra) for the restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with HIV. Who’s Affected by Lipoatrophy Lipoatrophy as a phenotypic presentation of the facial appearance may arise from a multitude of factors including the inherent genetic expression of the aging process. Facial lipoatrophy may also be associated with the treatment of HIV with the highly active anti-retroviral treatments known as HAART therapy. While the exact mechanism of facial fat loss in HAART therapy remains unknown, its appearance is sudden, common and progressive. Even worse, the alteration in facial appearance can be a difficult to conceal “scarlet letter” of HIV infection, which in some individuals can lead to discontinuation of HAART therapy, with the resultant increased risk of progression of the disease. Facial lipoatrophy can also develop secondarily as a result of endurance exercise (long distance running), starvation/fad diets, diabetes, cancer, and genetically controlled (inherited) disorders of metabolism. Exploring Corrective Options Until recently, individuals with facial lipoatrophy were limited in options for correction. They could choose traditional invasive plastic surgery, perhaps with facial implants, fat transfer/grafting, silicone injections, or voluminous amounts of temporary (less than 1 year) dermal fillers such as collagen or hyaluronic acid. Clearly, none of these options were ideal, especially in the context of NSTFR (regardless of the motivation being restoration, rejuvenation or enhancement), where one approaches the aesthetic patient’s requests with a minimally invasive procedure list. The hallmark of which is characterized by a “low risk” and “high reward/satisfaction” profile. Ideally, these procedures are low in cost, low in “downtime” or recovery, low in risk of complications; they are also high in satisfaction, high in longevity, and high in “maintainability” or reproducibility, and highly (easily) correctable, if necessary. Again, in the context of NSTFR, there are standout procedures, such as Botox for the upper face; dermal fillers (collagen, hyalurons, and calcium hydroxyapitite) for the lower face/perioral region; a multitude of resurfacing options ranging from AHAs and retinoids through chemical peels, IPL with or without Levulan, and extending to CO2 laser resurfacing. Finally, there is maintenance with skincare products that at a minimum include the daily use of sunscreen. What has been missing (and sorely missed) from our checklist is the ability to shape or define, to correct, enhance or reduce in a broader sense the structural features of the face, especially the mid-face, so as to achieve a redefinition of the three-dimensional context of appearance, both concavity and convexity. Regardless of the motivation for alteration or correction, all patients enjoy certain facial proportions that from their perspective meet an ideal visage. For some it may be a sharpening of selected feature(s), for others perhaps a softening or contouring. For most, it means a reapportionment of ratios between areas of the face that re-approximates a healthy and youthful appearance. For many, this means a reduction in the concavity and a return to the convexity of the mid-face, a repair of deepening nasojugal, nasolabial, and mentolabial folds, lip enhancement, and re-establishing a sharp mandibular sweep with an appropriate cervico-mental angle. While there is no single agent that will perform all of these duties, our European colleagues have for the past 5 or more years been able to use poly-L-lactic acid, which is known as New-Fill outside the United States, for many of these aesthetic indications. Long Track Record of Success More than 150,000 patients have been treated outside the United States, principally for aesthetic concerns, with poly-L-lactic acid, or Sculptra as it is known in this country. The clinical responses of these patients have been reviewed and presented at essentially all major scientific and aesthetic meetings in the United States and abroad. The studies that have been performed have also been presented to the U.S. FDA as part of the approval process granted this summer. Clinical trials are ongoing for new indications, and perhaps most importantly, patients in this country have been able to enjoy the benefits of Sculptra for a variety of indications, both on and off label, for treatments including restoration, rejuvenation and enhancement. Additionally, some of the clinical experience gained with Sculptra has also been through its use in the repair and restoration of a normal facial appearance after Mohs surgery. Sculptra has been used post-surgically by the author (GLB) to repair soft tissue volume loss after extirpation of tumors in the mid-face region. Beginning 6 months post-repair, the depressed scar area(s) have been treated with a series of Sculptra injections at 3-week intervals to stimulate neocollagenesis. The results to date are very encouraging, and will be presented further in another format. Taking a Step-by-Step Approach The goal of this article is to share experience and knowledge gained from both clinical and trial use of poly-L-lactic acid, to assist the aesthetic dermatology practice in the rapid uptake and efficient use of Sculptra for the benefit of all aesthetic patients, including those who suffer from facial lipoatrophy of HIV infection and HAART therapy. Here, we’ll share six steps that we’ve found to be essential in attaining optimum outcomes with Sculptra. Step 1: Stress Patience Sculptra is an interesting product in that, in and of itself, Sculptra is not a dermal filler. In fact, Sculptra is not actually a filler at all, it is a biocompatible, biodegradable synthetic polymer akin to Vicryl suture. There is no requirement for pre-treatment skin testing. Sculptra is actually more of a “seed” or a catalyst that serves to stimulate the process of neocollagenesis in the areas where it is injected. The Sculptra that is injected is ultimately metabolized through non-enzymatic hydrolysis into glucose and CO2. The filling effect of dermal thickening is achieved through the process of native collagen formation, and this takes time (and patience)! When Sculptra is injected into an area, there is an immediate and transient volume correction secondary to the physical volume of the reconstituted product and tissue edema. The injection related volume resolves generally in 24 hours or less, leaving behind a paradoxical depression. Over the following weeks to months, there is a foreign body giant cell reaction as part of the tissue response, ultimately resolving in the production of collagen as the polymer degrades. Because of this delayed timeline of weeks to months, the full effects of Sculptra injections may take 3 to 6 months to develop. There will also be the need to do multiple injection sessions at 3- to 6-week intervals, with the average aesthetic patient requiring at least 3 injection sessions of a least one vial per session to achieve a complete response. Additionally, the total treatment benefit of Sculptra is not achieved in equal amounts with each injection; rather the results are “back-end loaded.” Proportionally more correction appears with the final treatment compared to the initial injection. Whether this is due the up-regulation of collagen synthesis over time, the effect of increasing amounts of the poly-L-lactic acid injected, or some other factor, is unknown at this time. What is important is the education to both the injector and patient to “be patient.” This timeline has several advantages for the novice injector, the primary one being results are achieved over time. This means the beginning injector has more room for error than with traditional fillers, as any irregularity of results stemming from injector inexperience may be compensated for on subsequent injection sessions. Step 2: Sign Consent Because Sculptra has a number of features (duration, cost, longevity, etc.) that differ from other dermal fillers, be sure to use an educational style consent form. Have the patient read, sign and take home a copy of the consent. This can serve to allay fears that the product is not working, or that it “disappeared” overnight. The consent can also serve as a gentle reminder that follow-up visits for multiple treatments are necessary to achieve optimal results. Ideally, the consent form will have multiple paragraphs where patients can initial to confirm that they have read the entire document. A sample consent form follows this article (available for download in PDF format). Sculptra users may wish to compare their existing consent to the sample and revise as necessary. As always, if there are any questions specific to your practice, consultation with your attorney and/or malpractice carrier is urged, and the sample consent is for educational purposes only and is not intended for patient use as a legal document. Step 3: take Photographs Because Sculptra therapy is a process which takes place over time, photographs taken before the procedure begins are an absolute must for every patient treated. Incremental results can be problematic as some patients may have less than ideal visual memories. The comparison of a baseline photograph can help reassure a patient partway through Sculptra therapy that improvement is indeed occurring. For the patient who has completed therapy, a before-and-after view can confirm results, guide follow-up treatments and serve as documentation in the medical record of treatment success. Also, with Sculptra the presence of photographs can help guide treatment decisions by comparing baseline and in-progress results to desired outcome, the final result may end up different than the initial intention. This is where the “artistic” component of Sculptra therapy plays a role, as the injector can literally “sculpt” the facial appearance one injection session at a time. For those offices that forget baseline photographs, simply have the patient return 1 or 2 days later after the injection, after the edema of the diluent (sterile water) has dissipated and the patient has returned to baseline. Finally, don’t forget to specifically obtain permission to take photographs! Step 4: Offer Packages Because Sculptra is a process that takes multiple injection sessions to achieve optimal correction, it is important to help the patient mentally obligate themselves. Think of Sculptra as a “fitness training program for the face,” and results take time. If the patient is not willing or able to complete the program, then the best results will never be obtained. By offering a package of treatment sessions, the full effect of the treatment program can be realized, and the patient is far less likely to stop partway through the recommended regimen. For most aesthetic patients, the package will be 1 vial of Sculptra per session, for 3 sessions, at 4-week intervals. Patients can purchase the package of three vials as one treatment program. If the patient needs less, a refund or credit toward other procedures can be given; if he or she needs more, then it is simple to sell additional treatments (vials). Consider offering a package discount to patients if they pay up front. This can be an incentive to commit to the full recommended treatment program, and helps to secure follow-up. The actual number of vials needed for any specific patient can only be estimated, as the clinical response is not completely predictable due to an individual patient’s variability in producing collagen after Sculptra injections. The amount of Sculptra used per treatment session is less of a variable than the total amount (number of treatment sessions) necessary to achieve full correction. This is a very important concept. The amount of Sculptra used per treatment session is relatively fixed, and is reflective of the surface area being treated, a two-dimensional effect. This is similar to the number of square feet of carpet needed to cover the floor of a room; it all depends on how big the room is, not how high the ceiling is. The amount of Sculptra needed per injection is reflective of how big the area being treated is, and how many areas are being treated each time — not how deep the areas are or how high you want to make them. Do not over-correct with Sculptra, use the fixed amount recommended per injection area (usually 0.1 ml to 0.2 ml) when using a 1/2-inch, 26-gauge needle in the tunneling or threading technique. If more correction is needed within a treated area, wait until the next treatment session. The degree of correction needed or desired, which is a 3-D effect, determines the number of treatments, not how much is used per treatment, which is fixed as above. Remember the TWA acronym: Treat – Wait – Assess. Step 5: Stay Deep The actual injection techniques used for Sculptra will vary based on the skills and experience of the injector, and the specific experience of the individual patient and his or her treatment areas. However, there are some general guidelines to help assure success and minimize complications. The most important concept is to remember that Sculptra is not a dermal filler, and as such, is not placed where one would typically inject a filler such as collagen or hyaluronic acid. Sculptra should be placed in the deep dermis or subcutaneously. European experience indicates that Sculptra can also be placed in the fat and muscle without complication. It does appear, however, that if Sculptra is placed too superficially in the dermis, or if not diluted sufficiently (5 ml per vial) that micro-nodules can form, leading to palpable or even visible elevations. Remember to stay deep and avoid complications. I also ask my patients to remember the 5-5-5 rule: gently massage the treated areas for 5 minutes, 5 times per day for 5 days post injection. If they have any problems remembering, I tell them to think of how many fingers they have on one hand. I personally like to use a 25-gauge needle, which is available in 5/8-, 1-, and 1.5-inch lengths. This gives me two advantages; the first is flexibility in tunneling or threading techniques, whereby using a longer needle, I am able to minimize percutaneous punctures and cover larger areas. The second is that the 25-gauge needle bore minimizes clogging during injections. Reconstituted Sculptra resembles a Kenalog suspension in its viscosity, and as such is prone to clogging. This is especially true if the product is not left to stand for at least 2 hours, although I prefer 12 to 18 hours as a minimum. Sculptra can be left standing for up to 72 hours after reconstitution as per FDA labeling. Regarding diluents, I always use 4 ml of sterile water for injection, and at the time of injection, I add 1 ml of 1% lidocaine (with or without epinephrine) to the vial for a total of 5 ml of diluent per vial. Additionally, leaving Sculptra in the vial rather than pre-filling syringes allows the injector to gently shake the product at the time of use to maintain the suspension. When holding the product in a syringe, keep a gentle rocking motion going to prevent clogging, and prior to each injection, gently pull back on the plunger to clear any sediment from the hub of the needle where clogging tends to occur. It also helps to inject quickly. If a clog does occur while injecting, gently pull back on the plunger to see if it will clear. If it doesn’t, then withdraw the needle from the patient and try clearing again. If the needle remains clogged, then exchange it for another, and try again. Step 6: Secure Comfort As with any injection, Sculptra can hurt, and with the multiple injections needed to complete a treatment session, pain can become a factor. There are a number of approaches that can be used including facial nerve blocks, topical anesthesia, talk-esthesia, chilling (both before and after injections), and others. The best approach is of course that which works best in your office, however, some general guidelines are as follows: • Sculptra injections are sub-dermal, this tissue plane is not as tender as intradermal injections. • Nerve blocks are usually not needed. • Topical anesthetic creams are very effective at dulling each needle puncture through the skin. • Also, remember to change your needle frequently to maintain a sharp point. • There is lidocaine in the reconstitution, which helps to develop a zone of anesthesia if used wisely. • Chilling the treatment areas both before and after can be very effective at not only reducing pain, but also in reducing bruising. • A smooth hand and a calm voice go a long way in reducing patients’ anxiety. Achieving Outstanding Results In summary, Sculptra as a tissue molding and collagen building product has become another valuable addition to our armamentarium of aesthetic treatments. It is capable of being much more than just another dermal filler, and in fact is highly compatible with dermal filling agents such as hyaluronic acids, where it can be used in conjunction to achieve outstanding clinical improvement. Sculptra joins a rapidly growing list of aesthetic products and procedures in NSTFR, where it enjoys a unique niche as a foundation for facial sculpting. Perhaps easier to use than traditional dermal fillers, Sculptra is very forgiving by its very nature of multiple treatment sessions, where each previous treatment is assessed prior to initiation of the next treatment. As with all new products and procedures, Sculptra has a learning curve that when closely examined appears quite negotiable. The most important take- away messages are not to overcorrect, inject deeply, wait and assess each treatment session, and properly educate your patients and staff. Following these general recommendations will help assure success with Sculptra in simple steps, and bring an entirely new approach for developing the best methods for NSTFR.
