Efficacy and safety of high-intensity, high-frequency, non-focused ultrasound parallel beams for facial skin laxity.

BACKGROUND: Ultrasound energy has been used for dermal rejuvenation to treat fine lines, wrinkles and to lift lax skin. High intensity ultrasound waves induce thermal injury in the dermis, stimulating neocollagenesis and neoelastinogenesis. OBJECTIVE: To assess the efficacy, utility, and safety of a novel ultrasound device that uses high-intensity, high-frequency, non-focused ultrasound parallel beams to lift lax facial skin in the eyebrow, submental, and neck areas. MATERIALS AND METHODS: Fifteen subjects aged 40-69 years were enrolled in a prospective clinical trial. Two treatment sessions were performed with the high-intensity non-focused ultrasound parallel beam device followed by 3- and 6-month follow-up visits. Treatment results were assessed by study investigators, evaluating baseline and posttreatment photographs by applying physician global aesthetic improvement scale. Pain was evaluated immediately after each treatment using 0-10 visual analog scale. Any adverse event that occurred during the study period was documented and examined. RESULTS: Fifteen subjects with a mean age of 55 ± 2 years completed the study. Photographs that were taken at baseline and follow-up visits were compared and examined. An improvement pattern was detected in all treated areas in both follow-up visits and persisted stably throughout the study. The mean pain score was 5.6 according to the visual analog scale. CONCLUSION: The novel ultrasound device that uses high-intensity, high-frequency, non-focused ultrasound parallel beam was shown to improve safely and efficiently facial lax skin resulting in eyebrow, submental, and neck skin lift while experiencing tolerable pain.

Novel laser hair removal in all skin types.

BACKGROUND: Laser has been long accepted as a solution for excess or unwanted hair growth yet traditional lasers are not always ideal for safe and effective outcome for all skin types and hair characteristics. A diode laser module combining three wavelengths (755, 810, and 1064 nm) in a single pulse was developed to provide a fast and long-term solution for subjects with various profiles. AIMS: To evaluate the safety and efficacy of a Triple wavelength diode laser module for hair removal treatment in all skin types (Fitzpatrick I-VI). SUBJECTS AND METHODS: This was a prospective, dual centered, single-arm study. Subjects were treated with a novel diode laser module. Thirty-six subjects were enrolled, sixteen with Fitzpatrick skin types I-IV (46%) and twenty with Fitzpatrick skin types V-VI (54%). Treatment areas were axilla and bikini lines. Subjects underwent 4 treatment sessions at 6 weeks ± 5 days intervals and attended a follow-up visit 3 months after the last treatment session. 2D digital photographs were taken at baseline and at the follow-up visit, and a hair count was conducted by three blinded evaluators. RESULTS: A significant reduction in hair count between baseline and the 3-month follow-up visit was observed in both axilla and bikini lines for all skin types. The mean hair reduction was 41.5 ± 19.4% and 48.1 ± 20.9% in the axilla and bikini line, respectively. A significant hair reduction was also observed within skin type groups; mean hair reduction 45.5 ± 16.9% and 40.3 ± 17.2% in skin types I-IV and V-VI, respectively, indicating similar efficacy for both light and dark skin types. No serious adverse events were reported. CONCLUSIONS: This study demonstrates that the Soprano Titanium laser platform is safe and effective for hair removal treatment in all skin types.

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.

Safety and efficacy for hair removal in dark skin types III and IV with a high-powered, combined wavelength (810, 940 and 1060 nm) diode laser: A single-site pilot study.

BACKGROUND: Previous studies have demonstrated the superior efficacy of a high-power diode laser (4800 W) with a wavelength of 810 nm over others with less power and the same wavelength, while also being safe and comfortable for the patient. However, the use of this laser is limited on dark skin. OBJECTIVES: This study aims to compare the efficacy, safety, and comfort of a 4800 W diode laser (810 nm) with that of the new Blend diode laser (810 nm, 940 nm, and 1064 nm). Furthermore, the study aims to demonstrate that the Blend diode laser delivers better results on darker skin. MATERIALS AND METHODS: A 810 nm diode laser was compared with the Blend diode laser (810, 940 and 1064 nm) (Primelase, Cocoon Medical). A side-by-side comparative study was carried out over three sessions involving fourteen participants with skin types III and IV, with evaluation of the results 6 months after treatment. The study was performed at the Tennessee Clinical Research Center, Nashville, Tennessee, USA. This evaluation was based on efficacy, safety, comfort, and participant satisfaction. RESULTS: Blend diode laser treatments were performed with fluences 40% (SE = 0.04%) higher than those of the 810 nm. Besides mild-to-moderate transient discomfort during the procedure, the Blend diode laser also produced an increased pricking sensation that was 1.8 points higher on a 10-point scale (p < 0.05), due to the higher fluence used. Hair reduction was 12% higher with the Blend diode laser, with a confidence level of 70%. Moreover, participants were more satisfied with the results of the Blend diode laser than with the diode laser (50% very satisfied vs. 36%, respectively). No long-term adverse effects were observed. CONCLUSIONS: The new Blend diode laser has been shown to be more effective and satisfactory than 810 nm diode laser on dark skin types III and IV, while also being safe and comfortable for participants.

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.

Improvement of wrinkles and skin tightening using TriPollar® radiofrequency with Dynamic Muscle Activation (DMA™).

BACKGROUND: Radiofrequency (RF) energy promotes skin renewal by inducing tissue remodeling through dermal heating and neocollagenesis. AIM: To evaluate the safety and effectiveness of a medical esthetic system that combines simultaneously TriPollar® RF energy with Dynamic Muscle Activation (DMA™) for improving facial skin tightness and wrinkles. METHODS: A prospective, open-label study. Eleven subjects (mean age, 43 years; Fitzpatrick skin type II-IV) with Fitzpatrick Elastosis Scale (FES) score 3-6 were treated. The participants underwent six weekly treatments. Effectiveness of the treatments was evaluated at 1 and 3 months follow-ups after the last treatment, using the FES and evaluator- and subject-rated Global Aesthetic Improvement Scale (GAIS). Treatment safety and tolerance were evaluated as well. Pain was evaluated on a visual analog scale (VAS) of 0-10. RESULTS: Treatment was safe, with minimal pain (VAS score less than 1), no adverse events, and no downtime. At 1 and 3 months follow-up evaluation, mean physician-rated FES statistically significantly improved from baseline (4.63 ± 0.88) by 2.27 ± 0.45 for both time points (P < .0001). According to investigator GAI scale at 3 months follow-up evaluations, 81.8% of patients were improved and 18.2% were much improved in fine lines, wrinkles and skin tightness. CONCLUSIONS: Treatment with RF TriPollar® combined with DMA™ is effective and well-tolerated treatment for improving skin tightness and reducing wrinkles.

Improvement of skin texture and wrinkles using radiofrequency ultra-thin electrode technology.

BACKGROUND: Application of radiofrequency (RF) energy with microneedles to facial skin shown to promote skin renewal. AIM: To evaluate the safety and efficacy of the VoluDerm technology with 100 ultra-thin electrodes gen100 tip for improvement of skin texture and wrinkles. METHODS: A prospective, open-label, intra-individual-controlled trial. Twelve subjects (mean age, 45.5; Fitzpatrick skin types II-III) with Fitzpatrick Elastosis Scale (FES) score 3-6 were treated with VoluDerm RF technology using the gen100 ultra-thin electrodes disposable tip. The participants underwent three treatments at 3-week intervals. Treatment safety was evaluated at each treatment visit and at the follow-up visits (1 and 3 months post last treatment). Efficacy of treatment evaluated at 1 and 3 months after the last treatment using the FES as well as evaluator- and subject-rated Global Aesthetic Improvement Scale (GAIS). RESULTS: Treatment was well tolerated, with no downtime or adverse events. One and three months after the last treatment session, physician-rated FES showed statistically significant improvement of 2.67 ± 1.18 and 2.33 ± 1.03, respectively (P < .0001), from baseline (4.83 ± 0.69). According to the investigator assessment of improvement using the GAIS scale, all subjects had an improvement in skin texture and pigmentation and most of the patients (91.7%) had an improvement in skin brightness, tightness, and wrinkles. CONCLUSION: This is the first study evaluating the Legend+ RF System with VoluDerm technology using the novel gen100 ultra-thin electrodes tip. This study demonstrated effective and well-tolerated treatment for improving skin texture and appearance with minimal to no downtime.

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.

Evaluation of a new diode laser for the treatment of lower extremity leg veins.

INTRODUCTION: Visible leg veins are a common cosmetic concern treated mostly by 1064 nm Nd:YAG laser that has become the chosen laser therapy for treating all leg veins up to 3 mm in size. The objective of the current prospective study was to evaluate the safety and efficacy of a new 1064 nm diode laser for leg veins and spider veins on the lower extremities. METHODS: A total of 15 female subjects seeking leg veins and spider veins treatment were recruited to this study. The treatment protocol included two treatment sessions 6 weeks apart and two follow-up visits at three and 6 months after the last diode laser treatment. Results were evaluated by photographs and an investigator classification of the treated vascular lesions appearance on five scores scale from 0 (normal) to 4 (severe). RESULTS: Treatment area photos demonstrated improvement in vascular lesions appearance. Average vascular lesions classification was reduced by approximately one score from baseline score of 2.9 (score 3 is moderate) to an average score 2 (mild) at the 3-month follow-up visit. This improved classification sustained also at 6-month follow-up visit, indicating the long-term effect of the treatment impact. No significant or unexpected adverse events were detected in any of the patients as a result of the treatments. CONCLUSIONS: This study has demonstrated that the new 1064 nm diode laser is safe and effective for the treatment of leg vascular lesions on the lower extremities.

Randomized, single-blinded, crossover study of a novel wound dressing vs current clinical practice after percutaneous collagen induction therapy.

INTRODUCTION: Skin rejuvenation procedures have become common with sophisticated technologies with reduced downtime and related risks. Recently, microneedling has been paired with radiofrequency to create Fractional Radiofrequency Microneedling (FRFM) to induce neocollagenesis. Frequently, topical products are applied immediately after the needling. This procedure is known as percutaneous collagen induction therapy (PCIT). Postoperative topical wound care is critical for prompt rapid and safe healing, with moist wound healing deemed of primary importance for fast and correct scarring process. An ideal dressing enables a moist environment while reducing postprocedural inflammatory responses in the first stages of wound healing. OBJECTIVE: To evaluate whether an innovative silicone-based wound dressing is superior than standard of care therapy in decreasing severity and duration of treatment-site acute inflammatory reactions post PCIT. MATERIALS AND METHODS: Endymed PRO Intensif Handpiece (Endymed, Israel) was used for the full-face FRFM procedure. Subjects (n = 20) applied treatment (Stratacel® -Stratpharma SG, Switzerland) and control (Aquaphor® -Beiersdorf Inc, USA) immediately after the procedure and daily; they were evaluated immediately postprocedure (baseline assessment), at 2, 3 and 7 days postprocedure. Digital and 3D pictures (Antera 3D Camera for Skin Analysis-Miravex, Ireland) were taken at each assessment. RESULTS: All patients healed properly without reporting adverse reactions to any of the studied products. Erythema at each study visit was significantly reduced with the use of the novel wound dressing (P < 0.001). A statistically significant difference in favor of the innovative wound dressing also emerged with respect to the patient-rated product properties (P = 0.008), such as feel on skin, drying time and stickiness. CONCLUSIONS: The novel wound dressing reduced signs of acute inflammation following PCIT when compared to standard of care, without reporting adverse events and resulting in a more favorable outcome from a patient perspective.

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.

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.

Safety, efficacy, and usage compliance of home-use device utilizing RF and light energies for treating periorbital wrinkles.

BACKGROUND: The aging process is often associated with undesirable effects on facial skin such as skin redundancy, reduction of elasticity, and increased wrinkling. Radiofrequency (RF) and light-emitting diodes (LEDs) are widely used, clinically proven technologies for skin rejuvenation. STUDY OBJECTIVE: This study aimed to evaluate the safety, efficacy, and usage compliance of the home-use device, utilizing RF and LED energies, for self-treatment of periorbital wrinkles and improvement of skin appearance. STUDY DESIGN: Thirty-three subjects performed 21 treatment sessions every other day, over 6 weeks on the periorbital areas. In addition, two maintenance treatments were conducted 1 and 2 months following treatment end. Each subject served as his/her own control, comparing results before treatment, and 3 months following treatment end. RESULTS: Thirty subjects completed the study. A blinded, independent photographs assessment of three dermatologists demonstrated an average reduction of 1.49 Fitzpatrick scores (P < 0.001). Analysis revealed improvement (downgrade of at least 1 score) in almost all subjects. No unexpected adverse events were reported. Post-treatment erythema was seen in all subjects and disappeared within 1 h. In some subjects, post-treatment edema was detected and resolved within 24 h. High satisfaction with the device operation, ease of treatments, safety, and wrinkle reduction was reported. CONCLUSIONS: The Silk'n Home Skin Tightening (HST) device offers a safe and effective in-home noninvasive technique to improve the appearance of age-related periorbital wrinkles.

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.

Use of micro-focused ultrasound with visualization to lift and tighten lax knee skin (1.).

INTRODUCTION: Public interest in noninvasive, aesthetic treatments for the rejuvenation of appearance continues to grow. The following prospective, open-label, nonrandomized trial was conducted to evaluate the safety and efficacy of micro-focused ultrasound with visualization (MFU-V) for achieving lift and tightening of lax skin above the knee. MATERIALS AND METHODS: Healthy adult women (N = 30) with mild- to moderate bilateral skin laxity above the knees were enrolled. MFU-V was applied to a grid of eight 25 mm(2) squares above each knee. MFU-V was first applied using a 4 MHz, 4.5 mm transducer followed by a 7 MHz, 3.0 mm transducer. Approximately 320 treatment lines applied to each knee [corrected]. The primary efficacy endpoint was lifting and tightening of lax skin above the knee as determined by the principle investigator using the Physician Global Aesthetic Improvement Scale (PGAIS). RESULTS: Among 28 evaluable subjects, 24 subjects (86%) showed improved lifting and tightening of knee skin laxity at 90- and 180-day follow-up visits. Three subjects showed no change and the appearance of one subject worsened. There were no adverse events or evidence of skin injury. CONCLUSION: Similar to its safety and efficacy for tightening facial skin and reducing wrinkles, MFU-V is an effective, noninvasive method for reducing skin laxity and improving the appearance of skin above the knee. ClinicalTrials.gov Identifier: NCT01708434.

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.

Fractional Q-switched 1,064-nm laser for the treatment of photoaged-photodamaged skin.

INTRODUCTION: The Q-switched 1064-nm laser is associated with rapid vaporization and thermal expansion stresses leading to skin mechanical damage and is typically used for correction of exogenous and endogenous deep pigmentation. Giving the common place of fractional, infrared-domain milliseconds non-ablative lasers in aesthetic dermatology, a novel non-ablative fractional Q-switched 1,064-nm laser was studied for photoaged skin concerns. MATERIALS AND METHODS: Ten healthy female subjects (Age range: 35-53 years, mean: 44.3) and skin types I-IV were diagnosed with mild-to-moderate facial photo-damage, hyper-pigmentation, telangiectasia, laxity, skin roughness, and actinic keratosis. Subjects were treated with a new non-ablative fractional Q-Switched 1,064-nm Nd: YAG laser (Harmony XL, Alma Lasers Ltd.). Treatments consisted of four sessions at 2-4 week intervals. Follow-up (FU) visits were 1 and 3 months following the final treatment. RESULTS: Utilizing the Glogau scale, six Subjects were graded Type II (means wrinkles in motion), and four Subjects were graded Type III (means wrinkles at rest) at Baseline. At the FU2, 3-month post final treatment, 60% of the subjects were graded with at least a one-point improvement in the overall Glogau global assessment. Between baseline and FU2, Investigator assessments showed the following improvements: Hyperpigmentation 70%, Telangiectasias 80%, Laxity 80%, Tactile Roughness 60%, and actinic keratoses 60%. Pain assessment was reported between 0 and 2 in all treatments (scale 0-10). Of expected side effects, erythema was most common, occasionally being reported as high as a 2(scale 0-10). No unexpected adverse effects were reported. CONCLUSION: The non-ablative fractional Q-Switched 1,064-nm Nd: YAG laser is safe and effective in improving signs of mild-to-moderate photodamage skin irregularities with no downtime, no pain to only minimal pain, and without any adverse side effects.

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.