Efficacy and tolerability of a hyaluronic acid-based serum and a peptide-rich cream for the face and neck in subjects with photodamaged skin.

BACKGROUND: Barrier properties of the stratum corneum inhibit delivery of topical ingredients containing large molecules to desired targets in the skin. This study evaluated the efficacy and tolerability of a skincare regimen comprised of a hyaluronic acid-based serum (InF-HA) and a peptide-rich cream (InF-PEP) containing large molecular ingredients designed to improve the appearance and overall quality of skin. METHODS: This 12-week study evaluated changes from baseline in skin tone, skin texture, and lines/wrinkles (6-point grading scale) of twice-daily application of a two-part skincare regimen to the face and neck in female subjects with mild to moderate photodamage. Subject satisfaction was assessed, and Adverse Events (AEs) were captured throughout. RESULTS: Seventeen subjects with a mean age of 52 years completed the study. Improvements from baseline in the appearance of facial skin texture (79%), lines/wrinkles (50%), and skin tone (44%) occurred at week 12. Improvements in neck appearance from baseline were demonstrated in skin texture (68%), skin tone (48%), and lines/wrinkles (36%). No AEs occurred related to the use of study products. All subjects reported an overall improvement in the appearance of their skin and that their skin looked and felt smoother; 88% reported their skin looked more radiant, and 82% reported their skin looked firmer. CONCLUSIONS: Application of a skincare regimen comprised of an HA-based serum and a peptide-rich cream led to substantial improvements in skin texture, skin tone, and lines/wrinkles on the face and neck over 12 weeks. Both products were well-tolerated with a high level of subject satisfaction.

Treatment of Mild to Moderate Facial Chrono- and Photodamage with a Novel Intense Liquid Trichloroacetic Acid Peel.

Background: Chemical peeling with trichloroacetic acid (TCA) is a well-established modality to improve the appearance of chrono- and photodamaged skin. Objective: We sought to evaluate the efficacy and safety of a novel formulation of TCA and hydrogen peroxide for the treatment of chrono- and photodamaged skin. Methods: Healthy subjects (N=5, 100% female) aged 49 to 72 years and Fitzpatrick Skin Types II (n=2) and III (n=3) enrolled in the Institutional Review Board-approved study. Subjects had mild to moderate facial wrinkles. Subjects were treated with a TCA-peroxide product four times at one-week intervals and applied at-home care products daily between visits. Investigator Global Assessments (IGA), investigator tolerability assessments, and subjective tolerability assessments were conducted on all subjects at each visit. The median score at each visit was calculated and compared to baseline using the Friedman test for repeated measures. Results: Among IGA attributes, differences in median scores from baseline were significant among the four visits for tone (p=0.0174), smoothness (p=0.0014), texture (p=0.0017), redness, ((p=0.0013) and overall appearance (p=0.0073), while the difference approached significance for radiance (p=0.0749). Twenty percent of subjects showed immediate improvement in radiance, tone, smoothness, and texture (Visit 1, immediately after the initial treatment) while 100 percent of subjects showed improvement by Visit 3 for smoothness, texture, and redness, and the improvements persisted to the end of the study. The treatment was well-tolerated and adverse events were not observed. Conclusion: The TCA-peroxide and at-home care products appear to provide rapid and consistent improvement of chrono- and photodamaged skin without adverse effects.

A topical regimen improves skin healing and aesthetic outcomes when combined with a radiofrequency microneedling procedure.

INTRODUCTION: Novel topical products formulated using tri- and hexapeptide technology (TriHex Technology® ; Alastin Skincare® , Inc) are used to clear the extracellular matrix, stimulate neocollagenesis and elastogenesis, decrease inflammation, and accelerate the epidermal healing process. AIMS: This study assessed the efficacy of two topical tri- and hexapeptide-containing products pre- and post-treatment with radiofrequency (RF) microneedling of the photoaged neck with respect to healing and aesthetic outcomes. SUBJECTS/METHODS: In this open-label, nonrandomized study, eligible subjects underwent one screening visit, one RF microneedling procedure and follow-up visits on post-treatment Days 3, 7, 30, and 90. Subjects were instructed to apply one product to the neck for 2 weeks prior to treatment and 7 days post-treatment. On post-treatment Day 7, subjects switched to the other product until the end of the study. At each visit, subject and investigator questionnaires were completed and standardized digital images were obtained. RESULTS: Female subjects (N = 10) with a mean age of 51.3 years (range, 44-59 years) completed the study. All subjects achieved statistically significant improvements in Investigator Global Assessment scales at post-treatment Day 90 and reported improvement in all Skin Quality Assessments. Among Subjective Tolerability Assessments, all post-treatment reports of tingling and burning resolved by Day 3. 90% of stinging resolved by Day 3 with 100% resolving by Day 7. 40% of subjects had minimal itching on Day 3 which resolved by Day 7. Among the Investigator Post-treatment Tolerability Assessments, edema resolved in all subjects by Day 3 and erythema settled between Day 3 and Day 7. CONCLUSION: Pre- and post-treatment use of topical products formulated with tri- and hexapeptide technology appears to hasten healing and complement aesthetic outcomes associated with RF microneedling of the neck.

Randomized, side-by-side comparison of a topical photo-enhancer gel for hair removal: an efficacy and safety study.

Background: Novel protocols are evolving to enhance hair follicle damage while preserving safety and improving efficacy. Objectives: The safety and tolerability of a 755-nm diode laser was compared to a combined laser with topical photo-enhancer gel ("combined") versus laser alone ("solo"). Methods: Twenty women (age 23-33 years old), Fitzpatrick skin type I-V, were randomized to side-by-side comparisons with a laser hair removal protocol. The combined side received reduced laser energy compared to the solo side. The laser used in-motion super hair removal technology. Subjects received up to four treatments. Subjects were assessed at baseline and at 1 and 6 months after the last treatment. Results: At the 1-month follow-up, there were no statistical differences in percent hair reduction between the combined (81 ± 16%) versus the solo (77 ± 15%) protocols (p > 0.05). Similarly, at 6-month follow-up, there are no statistical differences between the combined (71 ± 24%) versus the solo (70 ± 23%) treatment protocols (p > 0.05). The average accumulative laser energy in the combined side was half of the solo side (4.2 ± 1.6 vs. 7.6 ± 2.7 kJ, respectively). Pain during the procedure was significantly higher in the solo (5.5 ± 1.8) versus the combined (3.8 ± 1.7) protocol (p < 0.001). Conclusion: A laser hair removal paradigm that combines a 755-nm diode laser with a photo-enhancer gel (reduced kJ protocol) is clinically effective as a solo treatment protocol.

An open-label, single-site study to evaluate the tolerability, safety, and efficacy of using a novel facial moisturizer for preparation and accelerated healing pre and post a single full-face radiofrequency microneedling treatment.

BACKGROUND: Skincare cosmeceutical products have been shown to address intrinsic and extrinsic skin aging. Radiofrequency (RF) with microneedling is effective and safe in improving skin laxity and texture. Pairing skincare cosmeceutical products pre- and post-procedure is beneficial as it enhances patient results, patient results, patient experience, and reduces patient downtime. OBJECTIVE: To evaluate the tolerability, safety, and efficacy of a multi-ingredient anti-aging facial moisturizer when applied pre- and post-procedure consisting of a single RF microneedling treatment. METHOD: Fifteen female patients, aged 37-60, Fitzpatrick skin types I-IV, with mild-to-moderate wrinkles were included in the study. Patients applied a multi-ingredient anti-aging facial moisturizer twice a day (morning and night) two weeks prior to RF microneedling and four weeks post-RF microneedling (twice a day). At each time point, investigator objective assessment, self-assessments, and clinical photography were taken. RESULT: There were no adverse events as evaluated by the investigator. For this combined treatment and procedure patient scored comfort as the highest for satisfaction. Tolerability parameters erythema and edema were reported after RF microneedling treatment and were significant compared to the pre-procedure timepoint. Eighty percent of patients showed an improvement in Glogau Wrinkle Scale, but improvement was not statistically significant between baseline and end of study. Improvements in all skin attributes (radiance, tone, smoothness, texture, redness, dryness, and overall appearance) were statistically significant at the end of the study. Self-perceived skin attribute improvements included overall improvement, brightness, texture, pigmentation, redness, and tightness. The combination of the anti-aging facial moisturizer and RF microneedling was recommended by the patients in this study. CONCLUSION: This clinical study positively supports the hypothesis that combining the multi-ingredient anti-aging facial moisturizer pre- and post-RF microneedling was safe and tolerable for the patients.

Facial skin rejuvenation by combination treatment of IPL followed by continuous and fractional radiofrequency.

OBJECTIVE: The objective of this study was to evaluate the safety and efficacy of combination facial treatment by 3 technologies. MATERIALS AND METHODS: Eleven patients completed the clinical trial that consisted of alternate treatments of intense pulsed light (IPL) in 3 sessions and continuous + fractional bipolar radiofrequency (RF) in 3 alternating sessions, 3 weeks apart. Follow-up visits were made at 6 and 12 weeks following the last treatment. Lesions were evaluated by photographs taken at baseline and at follow-up time points according to predetermined scales. RESULTS: Results showed statistically significant improvement in wrinkling (24% after 6 weeks and 33% after 12 weeks), pigmentation (38% after 6 weeks and 62% after 12 weeks), vascular lesions (29% after 6 weeks and 67% after 12 weeks), and laxity (37% after 6 weeks and 40% after 12 weeks). CONCLUSIONS: Combination facial treatment by IPL, and continuous and fractional RF is safe and enables the treatment of a variety of facial lesions, taking advantage of accessible applicators for different clinical indications on the same device. Thus, comprehensive facial skin rejuvenation has become feasible.

Clinical Evaluation of a Novel Intense Pulsed Light Source for Facial Skin Hair Removal for Home Use.

OBJECTIVE: The purpose of this Institutional Review Board-approved, open label, prospective study was to study the safety and efficacy of a novel pulsed light home hair removal device in patients with unwanted facial hair. MATERIALS AND METHODS: Seventeen patients were recruited into the clinical trial; two patients were lost to follow-up. Patients received six biweekly treatments with the novel home-pulsed light device in the facial areas below the level of the cheekbone. Follow-up visits were made at one and three months following the last treatment. RESULTS: The results showed statistically significant hair reduction numbers (22.7 at baseline to 4.4 at the end of the one-month follow-up time period and 7.0 at the end of the three-month follow-up time period) and percentages of 83.3 percent at one month post home-pulsed light device treatments and 78.1 percent at three months following the novel home-pulsed light device treatments. No adverse events with the device in the clinical evaluation were observed. CONCLUSION: This novel home use pulsed light device is a safe and effective at-home intense pulsed light device for facial hair removal.

Clinical and usability study to determine the safety and efficacy of the Silk'n Blue Device for the treatment of mild to moderate inflammatory acne vulgaris.

INTRODUCTION: Home devices for acne vulgaris have emerged as a way to utilize our current light based technology for the care of our patients suffering from acne vulgaris. MATERIALS AND METHODS: Patient received eight treatments with the Silk'n Blue device over a 4-week period. Follow-up visits were at 1 month and 3 months. RESULTS: Seventeen subjects were entered into this institutional review board (IRB) approved clinical research project. There was a statistically significant decrease in mean acne counts from baseline through the follow-up visits, p = 0.002. Percent reduction was also statistically significant, p = 0.041. The study also showed that 36.4% of the patients had complete clearance with the study device. 100% of the patients showed full comprehension with the label for the device. There were no adverse events. Photos were captured. DISCUSSION: The Silk'n Blue device has an array of 24 LEDs emitting a spectrum of light in the blue-violet range of light (405-460 nm). Subjects enrolled in this clinical trial clearly were able to understand the labeling for the device. CONCLUSIONS: The Silk'n Blue device is a safe efficacious at home device for the treatment of mild to moderate inflammatory acne vulgaris.

Safety and Cosmetic Effects of Photodynamic Therapy using Hexyl Aminolevulinate and Intense Pulsed Light: A Pilot Study Conducted in Subjects with Mild-to-moderate Facial Photodamage.

OBJECTIVE: To assess the cosmetic effects of photodynamic therapy with hexyl aminolevulinate cream and intense pulsed light in subjects with mild-to-moderate facial photodamage. DESIGN: Six-month, open-label, single-center, pilot study comprising three study treatments, each separated by 30 days, and two follow-up visits (one and four months following third treatment). SETTING: Tennessee Clinical Research Center, Nashville, Tennessee. PARTICIPANTS: Ten women (ages 36 to 64 years) with skin color classified as Fitzpatrick I to III. MEASUREMENTS: The investigator evaluated erythema, dryness, bruising, crusts and erosions, and stinging/burning immediately before and after each treatment and at each follow-up visit. In addition, the investigator rated cosmetic appearance at each follow-up visit. Subjects rated stinging, tingling, itching, and burning 15 minutes after each treatment and cosmetic effects (radiance, smoothness, pore appearance, evenness of skin tone, and overall effect) at each follow-up visit. RESULTS: Mean (standard error of the mean) objective cosmetic appearance scores were 0.900 (0.233) and 1.400 (0.267) (0=very much improved; l=much improved; 2=improved) one and four months following treatment, respectively. Mean subjective assessments of radiance, smoothness, pore appearance, evenness of skin tone, and overall effect ranged from 2.200 to 2.800 (2=much improved; 3=improved) one and four months following treatment. Mean objective erythema, dryness, bruising, and stinging/burning scores were <1 (minimal/slight) at all time points. Mean subjective post-treatment stinging, tingling, itching, and burning scores were <1 (mild) at all time points. CONCLUSION: Photodynamic therapy with hexyl aminolevulinate and intense pulsed light improved cosmetic appearance and was generally well tolerated. Further investigation in larger patient populations is warranted.

Treatment of facial photodamage using a novel retinol formulation.

BACKGROUND: Photoaged skin is characterized by a variety of clinical, histologic, and biochemical features. OBJECTIVE: To determine the efficacy of a new topical formulation of 1% retinol and the effects of this same formulation using a 0.5% retinol concentration to minimize irritation. METHODS: Patients at 2 sites (n=6, n=5) with photodamaged skin applied a novel suspension of retinol (1%) daily to their faces for 8 to 12 weeks. Clinicians graded improvement in ultraviolet-induced features at 4 to 6 weeks and at 8 to 12 weeks. Positive results of the observational pilot study warranted a follow-up study on the low concentration. At a third site, females (n=30) with facial photodamage applied the same formulation with or without retinol (0.5%) daily for 8 weeks. Twenty-two subjects applied the test product and 8 applied vehicle according to a randomized, double-blinded, institutional review board-approved protocol. Improvements in photodamage features were graded at 4 and 8 weeks. RESULTS: In the observational pilot study, most participants showed improvement in overall photodamage, crow's feet, elasticity,wrinkles, brightness, and hyperpigmentation at 60 to 80 days. Improvements at 60 to 80 days were greater than at 30 to 46 days. In the low-concentration study with 0.5% retinol, improvements were modest, most likely due to the lower retinol concentration. Burning, pruritus, dryness, and erythema were minimal with the 0.5% retinol concentration. CONCLUSIONS: The topical formulation of 1% retinol improves photodamaged skin for at least 8 to 12 weeks. Although improvements with the 0.5% retinol were more modest, side effects such as burning, dryness, pruritus, and erythema during the 8-week study period were minimal. These encouraging results justify a longer-term study to determine whether topically applied 0.5% retinol can provide benefits comparable with those seen with topically applied 1% retinol.

Treatment of acne scars by fractional bipolar radiofrequency energy.

BACKGROUND/OBJECTIVE: A variety of modalities are available for the treatment of acne scars. This prospective, IRB-approved study evaluates the efficacy and tolerance of fractional bipolar RF energy in the treatment of facial acne scars. METHODS: Healthy subjects (n = 15, 13 females, aged 35.7 ± 5.6 years [mean ± SD], skin types I-V) with mild to moderate acne scars received three monthly treatments with a fractional bipolar RF device. Improvement and tolerance were evaluated at each visit, including a 1-month and 3-month follow-up visit. RESULTS: Ten subjects completed the study. Physician-assessed acne scar severity was significantly reduced at 1 month and 3 months. Adverse effects were limited to transient erythema. Dryness, bruising and crusting erosion were limited. Subject-assessed stinging/burning, stinging (alone), tingling, itching and burning were also limited and consistent with each treatment. Subject-assessed fine lines and wrinkles, brightness, tightness, acne scar texture, pigmentation were all improved significantly. Satisfaction was high in 67-92% of subjects. CONCLUSION: Fractional bipolar RF energy is a safe and effective modality for the treatment of acne scars.

Combined superficial & deep fractional skin treatment for photodamaged skin--a prospective clinical trial.

BACKGROUND AND OBJECTIVES: Deep microthermal zones targeted by Fractional CO(2) lasers stimulate fibroblast activity, whereas superficial microthermal zones target the epidermal layer pigment. The new combination modality enables targeting both deep and superficial disorders. The study is designed to evaluate the improvement in photodamage and determine downtime. MATERIALS AND METHODS: This IRB approved study was aimed to evaluate histology phenotype of combined deep and superficial skin resurfacing. A 120-micron, focused CO(2) laser beam was used to create both deep and superficial fractional skin resurfacing using ultrapulse and continuous wave laser modes, respectively. Fifteen patients (skin types II-V) underwent combined treatment and returned for assessment at 1 week, 1 and 3 months to evaluate the clinical outcome. Additional histological analysis of human tissue was performed to elucidate the combined impact on tissue. RESULTS: Pre-clinical histologies demonstrated the ability to achieve fractional discrete 1.3-mm-diameter spots of superficial ablation with a uniform shallow and narrow area of coagulation while maintaining the deep, fractional 120-micron-ablation spot capabilities. Histologies of the human tissue confirmed the ability to control both superficial and deep fractional treatment using a single handpiece. Pigmentation was greatly reduced at the 1 month follow-up with significant textural improvement. No unexpected AEs or SAEs were reported. CONCLUSION: The new modality enables combined superficial and deep fractional impact and improvements that are demonstrated at both the phenotype and tissue level.

Clinical efficacy of home-use blue-light therapy for mild-to moderate acne.

INTRODUCTION: Blue-light light-emitting diode (LED) therapy has become widely used for the treatment of inflammatory acne. In this study we evaluated the efficacy of a home use blue-light LED application in improving lesions and shortening their time to clearance. METHODS: This was an IRB approved randomized self-control study. For each patient (n = 30), 2 similar lesions, one of each side of the face were chosen for treatment with either a blue-light LED hand-held or sham device. Treatments (n = 4) were conducted twice daily in the clinic and lesions were followed-up till resolution. Reduction in blemishes size and erythema and the overall improvement were evaluated by both the physician and the patients. Time to lesion resolution was recorded. RESULTS: There was a significant difference in the response of lesions to the blue-light LED application as opposed to the placebo in terms of reduction in lesion size and lesion erythema as well as the improvement in the overall skin condition (p < 0.025). Signs of improvement were observed as early as post 2 treatments. Time to resolution was significantly shorter for the blue-light LED therapy. CONCLUSION: The results support the effectiveness of using blue-light LED therapy on a daily basis for better improvement and faster resolution of inflammatory acne lesions.

Tolerability and Efficacy of Retinoic Acid Given after Full-face Peel Treatment of Photodamaged Skin.

OBJECTIVE: All-trans retinoic acid is a well-established topical treatment of photodamaged skin. This study assessed the tolerance and efficacy of all-trans retinoic acid after full-face treatment with a chemical peel. DESIGN: This was a split-face, randomized study. One side of each face was treated with peel and the other side with peel and all-trans retinoic acid (3%). Four treatments were given during the 10-week study period. SETTING: Physician office. PARTICIPANTS: Fifteen female subjects 39 to 55 years of age. MEASUREMENTS: RESULTS were evaluated at Baseline; Weeks 4, 7, and 10; and at a 13-week follow-up visit by dermal grading of visual symptoms of irritation, subjective experiences of irritation, clinical grading of skin condition, and self-assessment questionnaires. RESULTS: Both peel and peel plus all-trans retinoic acid treatments achieved significant improvement in fine lines, radiance, roughness, skin tone clarity, skin tone evenness, and hyperpigmentation appearance. Improvement in wrinkles and firmness was not observed in the peel plus all-trans retinoic acid arm, while pore appearance failed to improve in either treatment arm. Improvement in overall facial appearance was greater in the peel alone arm. Peel alone and the addition of all-trans retinoic acid did not cause dryness, edema, or peeling, and the frequency of peel-induced erythema did not increase with the addition of all-trans retinoic acid. Subject-perceived improvements with the peel treatment did not differ significantly from subject-perceived improvements of the peel plus all-trans retinoic acid treatment. Adverse events requiring intervention or discontinuing treatment were not observed in either treatment arm. CONCLUSION: The addition of all-trans retinoic acid after peel treatment does not significantly enhance peel-induced improvement in photoaging parameters, peel-induced adverse effects, and subject-perceived improvements.

Low-energy intense pulsed light for hair removal at home.

Low-energy intense pulsed light for hair removal at home was evaluated in this clinical trial. Twenty-two female patients were enrolled into an institutional review board-approved clinical trial. Patients received six biweekly treatments with the device, and clinical results with hair counts and pictures were performed at four weeks and three months following the last treatment. Ninety-five percent of the patients noted hair count reduction at the end of this clinical trial. Overall hair reduction was 78 percent at the one-month follow up and 72 percent at the three-month follow up. No serious adverse events were noted. This clinical trial confirmed the safety and efficacy of this device for hair removal at home.

Clinical evaluation of the SmartSkin fractional laser for the treatment of photodamage and acne scars.

BACKGROUND AND OBJECTIVE: Fractional photothermolysis with a CO2 laser shows promise in the treatment of photodamaged skin. The purpose of this study was to evaluate a fractional CO2 laser device (SmartSkin, Cynosure, Westford, MA) for the treatment of facial photodamage. METHODS: Twelve subjects seeking treatment of facial hyperpigmentation, skin laxity, wrinkles and fine lines, enlarged pores and acne scars enrolled in the study. Each subject was treated twice with the SmartSkin device at three- to five-week intervals. Results were evaluated at one week, one month and three months after the final treatment. RESULTS: All 12 subjects completed the study. Physician and subject assessments both indicated that clinical improvements in all photodamage parameters were apparent at one month and persisted at least three months. Improvements in acne scars were noted but not graded. Eleven subjects would recommend the treatment to family and friends. The median pain scores during the initial and final treatments were 2.00 and 2.00, respectively, on a scale of 0-5. Only one adverse effect, facial edema, was judged "probably related to treatment." CONCLUSION: The SmartSkin fractional laser device improves photodamaged skin for at least three months. The treatment was well tolerated and adverse effects were limited to transient facial edema.

Treatment of moderate to severe inflammatory acne vulgaris: photodynamic therapy with 5-aminolevulinic acid and a novel advanced fluorescence technology pulsed light source.

The use of photodynamic therapy (PDT) with 20% 5-aminolevulinic acid (ALA) for the treatment of acne vulgaris has been explored. This study evaluates the safety and efficacy of a new Advanced Fluorescence Technology (AFT) pulsed light source (420-950 nm) for photoactivation in ALA PDT for the treatment of moderate to severe inflammatory facial acne vulgaris. Nineteen subjects received 4 ALA PDT treatments with the AFT pulsed light source. Treatments were spaced 2 weeks apart. ALA was incubated for 15 to 30 minutes. At the end of the fourth treatment, the total reductions in inflammatory and noninflammatory lesion counts were 54.5% and 37.5%, respectively. Median Global Severity Scores suggest a trend toward reduction after several treatments. Investigator and subject assessments show moderate to marked improvement in most patients. The new AFT pulsed light source with ALA PDT appears to be a safe and effective modality for the treatment of moderate to severe inflammatory acne vulgaris.

Prospective clinical evaluation of 1440-nm laser delivered by microarray for treatment of photoaging and scars.

BACKGROUND AND OBJECTIVES: The use of thermal heating in microscopic zones is generically termed "microrejuvenation." The objective of this study was to evaluate the benefits of using a novel 1440-nm Nd:YAG laser (Affirm, Cynosure, Westford, MA) with a novel approach for microscopic heating. This device utilizes a microarray of lenses delivering a 10-mm beam as hundreds of high-fluence beamlets interspersed with a relatively uniform low-fluence background irradiation. STUDY DESIGN: Forty subjects (N = 40) at 2 study sites presenting with superficial rhytides and other symptoms of photoaging or scars received 3 treatments at 4-week intervals using a T-250 lens array. Total fluence ranged from 3.0 to 7.0 J/cm2. Zimmer air cooling was used for all treatments. No topical anesthetic was required. RESULTS: The most common immediate and expected clinical effects were erythema and edema lasting less than 24 hours, although 6 patients reported edema lasting for up to 1 week. There were no permanent side effects. In total, 2.7% of treatments resulted in temporary side effects, the most significant of which was a slight depression on the cheek (n = 1), which completely resolved within 3.5 months. Other side effects included localized areas of acneiform subcutaneous erythematous papules (n = 4) and a linear superficial crust (n = 1) with the original tip, all of which resolved within 1 week. One patient reported small erythematous subcutaneous nodules resolving in 17 days. Tenderness of the neck lasting from 2 weeks (n = 2) to 3 weeks (n = 1) was also reported. RESULTS: In all, 92% of the patients completed 3 treatments. Of these, 85% completed the 1-month follow-up. At the follow-up, 94% of subjects exhibited improvement in one or more categories, 82% exhibited mild to moderate improvement, and 12% exhibited good improvement. Side effects were minimal and included mild posttreatment erythema and edema resolving within 24 hours. Pain during treatment was judged minimal to moderate. Postauricular histology showed areas of thermal injury up to 250 microm deep and 150 microm wide. CONCLUSIONS: A 1440-nm beam split by a microlens array is a promising new approach for inducing nonablative neocollagenesis in the remodeling of scars and rhytids. Histologic evidence confirms the microcolumnar nature of collagen heating using this microarray.

Split-face comparison of photodynamic therapy with 5-aminolevulinic acid and intense pulsed light versus intense pulsed light alone for photodamage.

BACKGROUND: Photodynamic therapy (PDT) with a 5-aminolevulinic acid (ALA) photosensitizing agent and a variety of lasers and light sources has been shown to enhance the treatment of photodamaged skin and its associated actinic keratoses (AKs). The efficacy of short-contact, full-face ALA by PDT in photorejuvenation has also been demonstrated. OBJECTIVE: To evaluate short-contact (30 to 60 min) ALA-PDT with intense pulsed light (IPL) activation by comparing ALA-PDT-IPL with IPL alone. METHODS Sixteen patients were enrolled in a split-face study. One side of each patient's face received ALA-PDT-IPL and the other side received IPL alone. Three treatments were given at 1-month intervals, and follow-up visits occurred at 1 and 3 months after the final treatment. RESULTS: Thirteen patients completed the trial. Three months after the final treatment, improvement was greater in the ALA-PDT-IPL side than in IPL-alone side for all facets of photodamage-crow's feet appearance (55 vs 29.5%), tactile skin roughness (55 vs 29.5%), mottled hyperpigmentation (60.3 vs 37.2%), and telangectasias (84.6 vs 53.8%). The clearance rate of AK lesions was also higher (78 vs 53.6%). CONCLUSION: Short-contact ALA-PDT-IPL brings about greater improvement in photodamaged skin and greater clearance of AK lesions than IPL alone, further confirming the usefulness of ALA-PDT in photorejuvenation.

Treatment of sebaceous gland hyperplasia by photodynamic therapy with 5-aminolevulinic acid and a blue light source or intense pulsed light source.

Treatment of SGH by ALA-PDT with Blue Light Source or Intense Pulsed Light Activation. Sebaceous gland hyperplasia (SGH) lesions often present as a sign of photoaging and have proven difficult to treat. Photodynamic therapy (PDT) may be an effective treatment option. Twelve patients with SGH received PDT with 5-aminolevulinic acid (ALA, Levulan Kerastick, DUSA Pharmaceuticals, Inc) photosensitizing agent topically applied with a 30- to 60-minute drug incubation period. Patients received either 405-420 nm blue light (ClearLight PhotoClearing System, CureLight, Lumenis) for 15 minutes or intense pulsed light (IPL), 500-1,200 nm and 550 nm cut-off filter (VascuLight System, Lumenis) according to a randomization protocol. ALA-PDT was administered once per month for 4 consecutive months. Progress was evaluated at 4 and 12 weeks after the final treatment. More than a 50% reduction in the number of SGH lesions was achieved for patients in both treatment arms without lesional recurrence during the treatment and follow-up periods. All treatments were well-tolerated. Adverse effects were limited to mild, transient erythema (n = 2) and blisters (n = 1), which resolved without sequelae. ALA-PDT with either blue light or IPL photoactivation may provide therapeutic benefit without significant adverse effects in patients with SGH.