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Newer Treatments Offer Advantages

August 2003

D ermatologists are finding that lasers, light-based devices, radiofrequency and some of the other newer technological devices can be quite effective in treating acne. Treating acne with one of these devices — sometimes in combination with a topical medication — has the potential to have a sea change effect in the way patients are now treated for this condition, some dermatologists believe. The downside, however, is that many of these devices are still experimental when it comes to treating acne and no one is sure how many treatments patients will need and how often re-treatment will be necessary. However, devices and treatment techniques are rapidly changing and improving, so many promising therapies continue to emerge. What the FDA has Cleared or Approved for Treating Acne In August 2002, the ClearLight (Lumenis) was the first device cleared to treat acne. The FDA cleared this device, which uses high-intensity, narrow-band light, for treatment of moderate inflammatory acne vulgaris. Next came approval for the Smoothbeam laser (Candela) in October of last year. The Smoothbeam was the first laser to receive 510K clearance to treat acne. This 1450 nm diode laser is indicated for treating acne lesions on the back. In addition, Smoothbeam also received FDA clearance this past January to use the laser for treating atrophic acne scars. Then, this past May, the CoolTouch 1320 nm laser system (New Star Lasers) received clearance from the FDA for treating back acne and acne scars. The latest laser to receive clearance from the FDA is the NLite-V laser system (Photonics). Cleared in late June, this 585 nm pulsed dye laser is the first laser to be cleared by the FDA for treatment of inflammatory acne vulgaris on the face. Lastly, in June a new type of treatment utilizing light emitting diodes received marketing clearance from the FDA. The OmniLux Blue (Alderm LLC) is specifically indicated to treat moderate inflammatory acne vulgaris. This article will further discuss and highlight cases from each of these approved therapies as well as some others that are seeking FDA approval or are still experimental but hold promise. ClearLight As mentioned above, the ClearLight (Lumenis) was the first device cleared to treat acne. The FDA cleared this device, which uses high-intensity, narrow-band light, for treatment of moderate inflammatory acne vulgaris. The device works by targeting the bacterium Propionibacterium acnes by using high-intensity light to excite P. acnes porphyrins and in turn destroy them without damaging surrounding tissue. According to Lumenis, a multi-center clinical study of 120 patients at six centers was conducted using a 400-watt 407 nm to 420 nm halide lamp to deliver high-intensity light to areas of acne-affected areas of the skin. Patients underwent eight bi-weekly treatments and 80% of patients who had mild-to-moderate papulo-pustular acne experienced significant improvement in both inflammatory and non-inflammatory lesions. Inflammatory lesion counts decreased by a mean of more than 60% after treatment ended and by nearly 70% 2 weeks following the last treatment. Smoothbeam The first laser to receive 510K clearance to treat acne, the Smoothbeam (Candela) is a 1450 nm diode laser indicated for treating acne lesions on the back. The laser also received FDA clearance for treating atrophic acne scars. A multi-year study, which researched the Smoothbeam’s affect on back acne, was conducted at the Naval Medical center in San Diego. This study found that lesion counts were significantly reduced after one treatment and that patients had a reduction in lesions of more than 98% after four, 20-minute laser sessions. In addition, patients experienced a 6-month remission of acne lesions following treatment. CoolTouch The CoolTouch 1320 nm laser system (New Star Lasers) is indicated for treatment of back acne and acne scars. The laser targets the sebaceous glands without damaging the skin’s surface. According to New Star Lasers, the CoolTouch is also experimentally being used to treat acne scarring. A recent study by Jeffrey Dover, M.D., associate clinical professor of dermatology at Yale University School of Medicine, found positive results with the CoolTouch for treating acne scars. In his study, 60 patients with acne scarring underwent a series of six treatments at monthly intervals. Patients reported that the treatment was nearly pain-free, and all but two patients said they were highly satisfied with their outcomes. None of the patients in the study reported any adverse effects. NLite-V This 585 nm pulsed dye laser is the first laser to be cleared by the FDA for treatment of inflammatory acne vulgaris on the face. The NLite-V (Photonics) laser emits a wavelength of yellow light that heats small blood vessels, encouraging healing and stimulating collagen production. In clinical trials conducted at Hammersmith Hospital in London, 41 patients underwent treatment with the NLite-V for their acne. According to Photonics, patients experienced a 50% improvement in acne lesion counts after one 5-minute treatment session. Results typically lasted for up to 3 months. OmniLux Blue In June, the FDA gave marketing clearance to the OmniLux Blue (Alderm LLC), a device that uses a hinged planar array of light emitting diodes. Emitting narrowband 415 nm blue light at 40 mW/cm2, the OmniLux Blue is specifically cleared by the FDA to treat mild-to-moderate inflammatory acne vulgaris. Data from an open study of 30 patients (mean age of 18) received eight, 20-minute light treatments (415 nm, 40 mW/cm2) over a period of 4 weeks. Patients were assessed at weeks 1, 4 and 8 and voluntary assessment after that. For the 29 patients who completed the study, 28% achieved optimum clearance at 4 weeks post-treatment (average clearance was 76%); 55% achieved optimum clearance at 8 weeks (average clearance was 71%) and 17% achieved optimum clearance at 12 weeks (average clearance was 73%). Treatment was tolerated well, and patients reported few minor adverse events. IPL device pending FDA clearance The LuxV Handpiece, which is pending FDA clearance, can be used with both the MediLux and EsteLux Pulsed Light Systems (Palomar Medical Technologies). The LuxV has a spot size of 16 mm by 46 mm, a fluence range up to 20 J/cm2, pulse durations of 10 ms to 100 ms and a pulse rate of 0.5 Hz to 1 Hz. Radiofrequency Radiofrequency energy is produced by an electrical current instead of a light source. It’s not scattered by tissue or absorbed by melanin, making it possible for patients with Fitzpatrick skin types V and VI to undergo treatment. This type of energy can also penetrate more deeply into the dermis (3 mm to 6 mm) and subcutaneous tissue to heat or denature collagen and stimulate fibroblasts to form new collagen over time, subsequently tightening tissue. At right in the two photos are examples of radiofrequency in combination with blue light therapy in a patient whose acne was treated. This type of combination treatment (the Aurora by Syneron) is seeking approval from the FDA for treating acne. The Aurora combines optical energy at a 480 nm to 980 nm wavelength while also delivering radiofrequency electrical energy at 5 to 20 J/cm3. Another radiofrequency device, also not yet FDA approved for treating acne, is the ThermaCool TC (Thermage). In the two photos in the first column on page 71, you can see before and after examples of a patient treated for acne with this device. In the two photos in the second column on page 71, the patient was treated with 5-amino levulinic acid (ALA) and ELOS, a device that combines intense pulsed light and radiofrequency. 5-amino levulinic acid (Levulan) and photodynamic therapy An experimental treatment, ALA/PDT is successfully being tapped as a treatment for moderate to severe acne. Physicians are applying ALA for as little as 15 minutes and then using either an intense pulsed light device or pulsed dye laser to activate the areas where ALA was applied. The results have significant promise for treating severe cystic acne, as well as a whole host of other conditions, including actinic damage, rosacea (see photos above) and for certain types of skin cancers. In the two photos at the top of the page, a patient with severe acne benefited from this combination treatment. The patient case depicted in the patient case in the bottom two photos underwent treatment for rosacea. (For more information about how this new technique is being utilized, see the article "New Perspectives on Photorejuvenation" in the May 2003 issue of Skin & Aging.)

D ermatologists are finding that lasers, light-based devices, radiofrequency and some of the other newer technological devices can be quite effective in treating acne. Treating acne with one of these devices — sometimes in combination with a topical medication — has the potential to have a sea change effect in the way patients are now treated for this condition, some dermatologists believe. The downside, however, is that many of these devices are still experimental when it comes to treating acne and no one is sure how many treatments patients will need and how often re-treatment will be necessary. However, devices and treatment techniques are rapidly changing and improving, so many promising therapies continue to emerge. What the FDA has Cleared or Approved for Treating Acne In August 2002, the ClearLight (Lumenis) was the first device cleared to treat acne. The FDA cleared this device, which uses high-intensity, narrow-band light, for treatment of moderate inflammatory acne vulgaris. Next came approval for the Smoothbeam laser (Candela) in October of last year. The Smoothbeam was the first laser to receive 510K clearance to treat acne. This 1450 nm diode laser is indicated for treating acne lesions on the back. In addition, Smoothbeam also received FDA clearance this past January to use the laser for treating atrophic acne scars. Then, this past May, the CoolTouch 1320 nm laser system (New Star Lasers) received clearance from the FDA for treating back acne and acne scars. The latest laser to receive clearance from the FDA is the NLite-V laser system (Photonics). Cleared in late June, this 585 nm pulsed dye laser is the first laser to be cleared by the FDA for treatment of inflammatory acne vulgaris on the face. Lastly, in June a new type of treatment utilizing light emitting diodes received marketing clearance from the FDA. The OmniLux Blue (Alderm LLC) is specifically indicated to treat moderate inflammatory acne vulgaris. This article will further discuss and highlight cases from each of these approved therapies as well as some others that are seeking FDA approval or are still experimental but hold promise. ClearLight As mentioned above, the ClearLight (Lumenis) was the first device cleared to treat acne. The FDA cleared this device, which uses high-intensity, narrow-band light, for treatment of moderate inflammatory acne vulgaris. The device works by targeting the bacterium Propionibacterium acnes by using high-intensity light to excite P. acnes porphyrins and in turn destroy them without damaging surrounding tissue. According to Lumenis, a multi-center clinical study of 120 patients at six centers was conducted using a 400-watt 407 nm to 420 nm halide lamp to deliver high-intensity light to areas of acne-affected areas of the skin. Patients underwent eight bi-weekly treatments and 80% of patients who had mild-to-moderate papulo-pustular acne experienced significant improvement in both inflammatory and non-inflammatory lesions. Inflammatory lesion counts decreased by a mean of more than 60% after treatment ended and by nearly 70% 2 weeks following the last treatment. Smoothbeam The first laser to receive 510K clearance to treat acne, the Smoothbeam (Candela) is a 1450 nm diode laser indicated for treating acne lesions on the back. The laser also received FDA clearance for treating atrophic acne scars. A multi-year study, which researched the Smoothbeam’s affect on back acne, was conducted at the Naval Medical center in San Diego. This study found that lesion counts were significantly reduced after one treatment and that patients had a reduction in lesions of more than 98% after four, 20-minute laser sessions. In addition, patients experienced a 6-month remission of acne lesions following treatment. CoolTouch The CoolTouch 1320 nm laser system (New Star Lasers) is indicated for treatment of back acne and acne scars. The laser targets the sebaceous glands without damaging the skin’s surface. According to New Star Lasers, the CoolTouch is also experimentally being used to treat acne scarring. A recent study by Jeffrey Dover, M.D., associate clinical professor of dermatology at Yale University School of Medicine, found positive results with the CoolTouch for treating acne scars. In his study, 60 patients with acne scarring underwent a series of six treatments at monthly intervals. Patients reported that the treatment was nearly pain-free, and all but two patients said they were highly satisfied with their outcomes. None of the patients in the study reported any adverse effects. NLite-V This 585 nm pulsed dye laser is the first laser to be cleared by the FDA for treatment of inflammatory acne vulgaris on the face. The NLite-V (Photonics) laser emits a wavelength of yellow light that heats small blood vessels, encouraging healing and stimulating collagen production. In clinical trials conducted at Hammersmith Hospital in London, 41 patients underwent treatment with the NLite-V for their acne. According to Photonics, patients experienced a 50% improvement in acne lesion counts after one 5-minute treatment session. Results typically lasted for up to 3 months. OmniLux Blue In June, the FDA gave marketing clearance to the OmniLux Blue (Alderm LLC), a device that uses a hinged planar array of light emitting diodes. Emitting narrowband 415 nm blue light at 40 mW/cm2, the OmniLux Blue is specifically cleared by the FDA to treat mild-to-moderate inflammatory acne vulgaris. Data from an open study of 30 patients (mean age of 18) received eight, 20-minute light treatments (415 nm, 40 mW/cm2) over a period of 4 weeks. Patients were assessed at weeks 1, 4 and 8 and voluntary assessment after that. For the 29 patients who completed the study, 28% achieved optimum clearance at 4 weeks post-treatment (average clearance was 76%); 55% achieved optimum clearance at 8 weeks (average clearance was 71%) and 17% achieved optimum clearance at 12 weeks (average clearance was 73%). Treatment was tolerated well, and patients reported few minor adverse events. IPL device pending FDA clearance The LuxV Handpiece, which is pending FDA clearance, can be used with both the MediLux and EsteLux Pulsed Light Systems (Palomar Medical Technologies). The LuxV has a spot size of 16 mm by 46 mm, a fluence range up to 20 J/cm2, pulse durations of 10 ms to 100 ms and a pulse rate of 0.5 Hz to 1 Hz. Radiofrequency Radiofrequency energy is produced by an electrical current instead of a light source. It’s not scattered by tissue or absorbed by melanin, making it possible for patients with Fitzpatrick skin types V and VI to undergo treatment. This type of energy can also penetrate more deeply into the dermis (3 mm to 6 mm) and subcutaneous tissue to heat or denature collagen and stimulate fibroblasts to form new collagen over time, subsequently tightening tissue. At right in the two photos are examples of radiofrequency in combination with blue light therapy in a patient whose acne was treated. This type of combination treatment (the Aurora by Syneron) is seeking approval from the FDA for treating acne. The Aurora combines optical energy at a 480 nm to 980 nm wavelength while also delivering radiofrequency electrical energy at 5 to 20 J/cm3. Another radiofrequency device, also not yet FDA approved for treating acne, is the ThermaCool TC (Thermage). In the two photos in the first column on page 71, you can see before and after examples of a patient treated for acne with this device. In the two photos in the second column on page 71, the patient was treated with 5-amino levulinic acid (ALA) and ELOS, a device that combines intense pulsed light and radiofrequency. 5-amino levulinic acid (Levulan) and photodynamic therapy An experimental treatment, ALA/PDT is successfully being tapped as a treatment for moderate to severe acne. Physicians are applying ALA for as little as 15 minutes and then using either an intense pulsed light device or pulsed dye laser to activate the areas where ALA was applied. The results have significant promise for treating severe cystic acne, as well as a whole host of other conditions, including actinic damage, rosacea (see photos above) and for certain types of skin cancers. In the two photos at the top of the page, a patient with severe acne benefited from this combination treatment. The patient case depicted in the patient case in the bottom two photos underwent treatment for rosacea. (For more information about how this new technique is being utilized, see the article "New Perspectives on Photorejuvenation" in the May 2003 issue of Skin & Aging.)

D ermatologists are finding that lasers, light-based devices, radiofrequency and some of the other newer technological devices can be quite effective in treating acne. Treating acne with one of these devices — sometimes in combination with a topical medication — has the potential to have a sea change effect in the way patients are now treated for this condition, some dermatologists believe. The downside, however, is that many of these devices are still experimental when it comes to treating acne and no one is sure how many treatments patients will need and how often re-treatment will be necessary. However, devices and treatment techniques are rapidly changing and improving, so many promising therapies continue to emerge. What the FDA has Cleared or Approved for Treating Acne In August 2002, the ClearLight (Lumenis) was the first device cleared to treat acne. The FDA cleared this device, which uses high-intensity, narrow-band light, for treatment of moderate inflammatory acne vulgaris. Next came approval for the Smoothbeam laser (Candela) in October of last year. The Smoothbeam was the first laser to receive 510K clearance to treat acne. This 1450 nm diode laser is indicated for treating acne lesions on the back. In addition, Smoothbeam also received FDA clearance this past January to use the laser for treating atrophic acne scars. Then, this past May, the CoolTouch 1320 nm laser system (New Star Lasers) received clearance from the FDA for treating back acne and acne scars. The latest laser to receive clearance from the FDA is the NLite-V laser system (Photonics). Cleared in late June, this 585 nm pulsed dye laser is the first laser to be cleared by the FDA for treatment of inflammatory acne vulgaris on the face. Lastly, in June a new type of treatment utilizing light emitting diodes received marketing clearance from the FDA. The OmniLux Blue (Alderm LLC) is specifically indicated to treat moderate inflammatory acne vulgaris. This article will further discuss and highlight cases from each of these approved therapies as well as some others that are seeking FDA approval or are still experimental but hold promise. ClearLight As mentioned above, the ClearLight (Lumenis) was the first device cleared to treat acne. The FDA cleared this device, which uses high-intensity, narrow-band light, for treatment of moderate inflammatory acne vulgaris. The device works by targeting the bacterium Propionibacterium acnes by using high-intensity light to excite P. acnes porphyrins and in turn destroy them without damaging surrounding tissue. According to Lumenis, a multi-center clinical study of 120 patients at six centers was conducted using a 400-watt 407 nm to 420 nm halide lamp to deliver high-intensity light to areas of acne-affected areas of the skin. Patients underwent eight bi-weekly treatments and 80% of patients who had mild-to-moderate papulo-pustular acne experienced significant improvement in both inflammatory and non-inflammatory lesions. Inflammatory lesion counts decreased by a mean of more than 60% after treatment ended and by nearly 70% 2 weeks following the last treatment. Smoothbeam The first laser to receive 510K clearance to treat acne, the Smoothbeam (Candela) is a 1450 nm diode laser indicated for treating acne lesions on the back. The laser also received FDA clearance for treating atrophic acne scars. A multi-year study, which researched the Smoothbeam’s affect on back acne, was conducted at the Naval Medical center in San Diego. This study found that lesion counts were significantly reduced after one treatment and that patients had a reduction in lesions of more than 98% after four, 20-minute laser sessions. In addition, patients experienced a 6-month remission of acne lesions following treatment. CoolTouch The CoolTouch 1320 nm laser system (New Star Lasers) is indicated for treatment of back acne and acne scars. The laser targets the sebaceous glands without damaging the skin’s surface. According to New Star Lasers, the CoolTouch is also experimentally being used to treat acne scarring. A recent study by Jeffrey Dover, M.D., associate clinical professor of dermatology at Yale University School of Medicine, found positive results with the CoolTouch for treating acne scars. In his study, 60 patients with acne scarring underwent a series of six treatments at monthly intervals. Patients reported that the treatment was nearly pain-free, and all but two patients said they were highly satisfied with their outcomes. None of the patients in the study reported any adverse effects. NLite-V This 585 nm pulsed dye laser is the first laser to be cleared by the FDA for treatment of inflammatory acne vulgaris on the face. The NLite-V (Photonics) laser emits a wavelength of yellow light that heats small blood vessels, encouraging healing and stimulating collagen production. In clinical trials conducted at Hammersmith Hospital in London, 41 patients underwent treatment with the NLite-V for their acne. According to Photonics, patients experienced a 50% improvement in acne lesion counts after one 5-minute treatment session. Results typically lasted for up to 3 months. OmniLux Blue In June, the FDA gave marketing clearance to the OmniLux Blue (Alderm LLC), a device that uses a hinged planar array of light emitting diodes. Emitting narrowband 415 nm blue light at 40 mW/cm2, the OmniLux Blue is specifically cleared by the FDA to treat mild-to-moderate inflammatory acne vulgaris. Data from an open study of 30 patients (mean age of 18) received eight, 20-minute light treatments (415 nm, 40 mW/cm2) over a period of 4 weeks. Patients were assessed at weeks 1, 4 and 8 and voluntary assessment after that. For the 29 patients who completed the study, 28% achieved optimum clearance at 4 weeks post-treatment (average clearance was 76%); 55% achieved optimum clearance at 8 weeks (average clearance was 71%) and 17% achieved optimum clearance at 12 weeks (average clearance was 73%). Treatment was tolerated well, and patients reported few minor adverse events. IPL device pending FDA clearance The LuxV Handpiece, which is pending FDA clearance, can be used with both the MediLux and EsteLux Pulsed Light Systems (Palomar Medical Technologies). The LuxV has a spot size of 16 mm by 46 mm, a fluence range up to 20 J/cm2, pulse durations of 10 ms to 100 ms and a pulse rate of 0.5 Hz to 1 Hz. Radiofrequency Radiofrequency energy is produced by an electrical current instead of a light source. It’s not scattered by tissue or absorbed by melanin, making it possible for patients with Fitzpatrick skin types V and VI to undergo treatment. This type of energy can also penetrate more deeply into the dermis (3 mm to 6 mm) and subcutaneous tissue to heat or denature collagen and stimulate fibroblasts to form new collagen over time, subsequently tightening tissue. At right in the two photos are examples of radiofrequency in combination with blue light therapy in a patient whose acne was treated. This type of combination treatment (the Aurora by Syneron) is seeking approval from the FDA for treating acne. The Aurora combines optical energy at a 480 nm to 980 nm wavelength while also delivering radiofrequency electrical energy at 5 to 20 J/cm3. Another radiofrequency device, also not yet FDA approved for treating acne, is the ThermaCool TC (Thermage). In the two photos in the first column on page 71, you can see before and after examples of a patient treated for acne with this device. In the two photos in the second column on page 71, the patient was treated with 5-amino levulinic acid (ALA) and ELOS, a device that combines intense pulsed light and radiofrequency. 5-amino levulinic acid (Levulan) and photodynamic therapy An experimental treatment, ALA/PDT is successfully being tapped as a treatment for moderate to severe acne. Physicians are applying ALA for as little as 15 minutes and then using either an intense pulsed light device or pulsed dye laser to activate the areas where ALA was applied. The results have significant promise for treating severe cystic acne, as well as a whole host of other conditions, including actinic damage, rosacea (see photos above) and for certain types of skin cancers. In the two photos at the top of the page, a patient with severe acne benefited from this combination treatment. The patient case depicted in the patient case in the bottom two photos underwent treatment for rosacea. (For more information about how this new technique is being utilized, see the article "New Perspectives on Photorejuvenation" in the May 2003 issue of Skin & Aging.)

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