Clinical evaluation of a new fractional ablative 2910 nm erbium laser on photodamaged skin: A pilot study.

OBJECTIVE: To examine the efficacy and safety of a new fractional, ablative erbium:glass fiber (Er:glass) laser (2910 nm) at improving clinical signs of photodamaged skin. MATERIALS AND METHODS: Thirty-seven healthy participants aged 38-75 years with photodamaged skin were enrolled into two treatment groups. Group A (n = 14) received up to four laser treatments with mild settings, and focal facial subunits were treated with deeper settings. Group B (n = 23) received a single treatment using deeper settings. Following treatment, pain scores and severity and duration of skin responses (erythema, edema, and pinpoint bleeding) were assessed. Primary outcome was the improvement in participant and investigator Global Aesthetic Improvement Scale (GAIS) at 3-month follow-up. Secondary outcomes were participant satisfaction with treatment and whether they would repeat treatment. RESULTS: Thirty-five participants completed the study (n = 1 lost to follow up in each group). Both groups had similar mean participant and investigator GAIS scores of 3/5 corresponding to "Improvement." All but two patients (both from Group A) reported improvement, satisfaction with treatment, and would repeat treatment. Posttreatment skin responses were mild-to-moderate, lasting up to 5 days. There was no scarring or dyspigmentation. CONCLUSION: The 2910 nm Er:glass laser provided improvement in photoaging with high patient satisfaction.

Feasibility Study of Electromagnetic Muscle Stimulation and Cryolipolysis for Abdominal Contouring.

BACKGROUND: In addition to reducing subcutaneous fat for body contouring, some patients are interested in toning the underlying muscle layer. OBJECTIVE: This feasibility study evaluated the safety and efficacy of electromagnetic muscle stimulation (EMMS) alone, cryolipolysis alone, and cryolipolysis with EMMS for noninvasive contouring of abdomen. METHODS: Abdomens of 50 subjects were treated in a study with 3 cohorts: EMMS alone, Cryolipolysis alone, and Cryolipolysis + EMMS in combination. Electromagnetic muscle stimulation treatments were delivered in 4 sessions over 2 weeks. Cryolipolysis treatments were delivered in one session. Combination treatments consisted of one cryolipolysis and 4 EMMS visits. Efficacy was assessed by independent physician Global Aesthetic Improvement Scale (GAIS), circumferential measurement, Subject GAIS (SGAIS), and Body Satisfaction Questionnaire (BSQ). RESULTS: Safety was demonstrated for all study cohorts with no device- or procedure-related adverse events. Independent photo review showed greatest mean GAIS score for the Cryolipolysis + EMMS cohort followed by Cryolipolysis only, then EMMS only cohort. BSQ showed greatest average score increase for Cryolipolysis + EMMS cohort followed by Cryolipolysis only cohort, then EMMS only cohort. Mean circumferential reduction measurements were greatest for Cryolipolysis + EMMS cohort followed by Cryolipolysis only, and then EMMS only cohort. The mean SGAIS improvement score was equal for the Cryolipolysis only and Cryolipolysis + EMMS cohorts, followed by the EMMS only cohort. CONCLUSION: A multimodal approach using cryolipolysis and EMMS was safe and demonstrated enhanced body contouring efficacy for this feasibility study.

Long-term Facial and Body Hair Removal With a Combined Radiofrequency and Optical Home-Use Device for All Skin Types.

OBJECTIVES: To evaluate long term effectiveness and safety with the use of a combined radiofrequency and optical home hair removal device in all skin types and over both facial and body areas. METHODS: A combined intense pulsed light (IPL) and radiofrequency (RF) home device was used for hair removal. Two separate study designs were evaluated. In the first design, bilateral body areas were treated with 7 weekly procedures and then unilateral areas received up to 12 monthly maintenance treatments while the corresponding other side received no further therapy. For the second design, facial areas received 4 procedures in 2 to 5 days visits, followed by 2 weekly, and then 6 biweekly procedures. All patients in both study designs had hair count evaluations up to 12 months post their last procedure. The highest energy used was 4 J/cm². RESULTS: In the first design, 58 subjects participated of which 15% were skin types V-VI. A total of 188 anatomical sites were treated. Hair reduction at 6 and 12 months post the last procedure was 56% and 52% respectively for the maintenance side and 47% and 37% for the non-maintenance side. For the second design, 19 subjects had 59 facial sites treated. Fifteen percent were skin types V –VI. The overall hair reduction at the end of receiving their procedures was 45%. At 12 months post the last procedure, the hair reduction was 42%. Aside for transient mild erythema, there were no adverse effects noted. CONCLUSIONS: Long term persistent hair reduction was achieved using an RF/IPL home-use hair reduction device. The combination of RF and optical energies allowed for the effective application of low energy usage. All skin types and both facial and body anatomical regions tolerated the procedures very well. J Drugs Dermatol. 2020;19(5):498-503. doi:10.36849/JDD.2020.4741.

Nano-Pulse Stimulation Induces Changes in the Intracellular Organelles in Rat Liver Tumors Treated In Situ.

BACKGROUND AND OBJECTIVES: Nano-pulse stimulation (NPS) therapy is the application of ultrafast pulses of high amplitude electrical energy to tissues to influence cell function. Unique characteristics of these pulses enable electric field penetration into the interior of cells and organelles to generate transient nanopores in both organelle and plasma membranes. The purpose of this study is to document the temporal and physical changes in intracellular organelles following NPS therapy using electron microscopy. STUDY DESIGN/MATERIALS AND METHODS: Liver tumors were induced in five buffalo rats by implanting syngeneic McA-RH7777 hepatocellular carcinoma cells into the surgically exposed livers. Tumors were allowed to grow for 1 week and then the surgically exposed livers were treated in situ with NPS energy delivered at a sufficient level to trigger regulated cell death in the tumor. Samples of NPS-treated and control tissue were removed and fixed for electron microscopy at 1 minute, 5 minutes, 30 minutes, 2 hours and 4 hours after exposure. RESULTS: Measurements of cellular organelles indicate strong swelling following NPS therapy exposure compared with untreated controls. The mean diameter of the mitochondria increased by 55% within 1 minute and then by 2.5-fold by 2 hours post-NPS therapy. The rough endoplasmic reticulum (RER) cisternae swelled immediately after NPS therapy with reduced swelling by 30 minutes and loss of structural integrity by 2 hours. The Golgi apparatus appears swollen in images collected 1 and 5 minutes after NPS therapy and was no longer detected at 30 minutes and 2 hours post-NPS therapy. By 4 hours after NPS therapy, a nascent Golgi apparatus was detected in many of the images. The plasma membrane lost its well-defined morphology and became less linear, exhibiting discontinuities as early as 1 minute post-NPS energy exposure and the nuclear envelope became subjectively less distinct over time. CONCLUSIONS: NPS therapy at sufficient energy levels causes the rapid swelling of organelles, disintegration of the RER, breaks in the plasma membrane and blurs the borders of the nuclear envelope. These changes in the mitochondria and RER are indicative of a regulated cell death process. These immediate physical changes to vital cell organelles are likely to trigger subsequent regulated cell death mechanisms observed in other studies of NPS therapy. Lasers Surg. Med. © 2020 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals, Inc.

Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Sebaceous Gland Hyperplasia.

BACKGROUND: Nanosecond pulsed electric field (nsPEF) technology involves delivery of ultrashort pulses of electrical energy and is a nonthermal, drug-free technology that has demonstrated favorable effects on cellular structures of the dermis and epidermis. OBJECTIVE: Determine the tolerability and effectiveness of nsPEF treatment of sebaceous gland hyperplasia (SGH). METHODS: This study was a prospective, randomized, open-label, multisite, nonsignificant risk trial in which each subject served as their own control. After injection of local anesthetic, high-intensity, ultrashort pulses of electrical energy were used to treat 72 subjects resulting in a total of 222 treated lesions. Subjects returned for 3 to 4 follow-up evaluations with photographs. RESULTS: At the final study visit, 99.6% of treated SGH lesions were rated clear or mostly clear and 79.3% of the subjects were satisfied or mostly satisfied with the outcome. At 60 days after nsPEF treatment, 55% of the lesions were judged to have no hyperpigmentation and 31% exhibited mild post-treatment hyperpigmentation. At the last observation for all lesions, 32% of the 222 lesions were noted as having slight volume loss. CONCLUSION: Nanosecond pulsed electric field procedure is well tolerated and is very effective in the removal of SGHs. TRIAL REGISTRATION: ClinicalTrials.gov NCT03612570.

Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Seborrheic Keratoses.

BACKGROUND: Nanosecond pulsed electric field technology (also known as Nano-Pulse Stimulation or NPS) is a nonthermal, drug-free, energy-based technology that has demonstrated effects on cellular structures of the dermis and epidermis in previous clinical studies. OBJECTIVE: To evaluate the safety and efficacy of a single NPS treatment for clearing seborrheic keratoses (SKs). MATERIALS AND METHODS: This study was a prospective, randomized, open-label, multisite, nonsignificant risk trial in which each subject served as their own control. Fifty-eight subjects had 3 of 4 confirmed SK lesions treated, resulting in 174 total treated lesions. Subjects returned for 5 to 6 follow-up evaluations and photographs. RESULTS: At 106 days after NPS treatment, 82% of treated seborrheic keratoses were rated clear or mostly clear by the assessing physician. Seventy-one percent of lesions were rated clear or mostly clear by the 3 independent reviewers based on the 106-day photographs. All treated subjects returned for all study visits, and 78% of the subjects were satisfied or mostly satisfied with the outcome of the treatment. No adverse events were reported. CONCLUSION: The NPS procedure was well tolerated and effective in the removal of SKs.

In-Vivo Histological Analysis of a Fractional CO2 Laser System Intended for Treatment of Soft Tissue.

BACKGROUND: Fractional ablative lasers have been shown to be safe and effective for improving wrinkles, scars, skin texture, and dyspigmentation. However, the exact effects of this technology in vivo on epidermal and dermal skin constituents have not been delineated. This study evaluated the in vivo histological effects over time of treatment with a fractional ablative CO2 system, using different treatment parameters. MATERIALS AND METHODS: Healthy adult volunteers were enrolled in this multicenter clinical study. Study participants, previously scheduled for abdominoplasty, received fractional CO2 laser treatment on the abdomen at a predetermined time prior to surgery. Biopsies were taken at baseline and after CO2 treatment. Morphological and morphometric analyses were performed in the ablated and coagulated tissue areas. RESULTS: Nine healthy adult volunteers were treated. Histologic evaluation showed 800-900 micron diameter zones of ablation and coagulation confined to the upper most layer of the skin in the mode with the greatest fractional skin coverage using Light Mode 30 - 50% (spot diameter of 150 microns, 30-60 millijoules fluence), while ablation to levels of up to 900 microns in depth using the Deep Mode (spot diameter 150 microns, 50-80 millijoules). Healing times of treated tissue varied from 1-day post-treatment with the Light Mode, and up to 10 days post-treatment with the Deep Mode. No remnants of ablation or coagulation were seen after 30 days post CO2 treatment with either mode. There were no adverse events associated with treatments. CONCLUSION: Treatment of the skin using the fractional CO2 device leads to skin resurfacing via ablation and coagulation of the treated area at a depth proportional to the delivered energy. The higher the energy used, the greater the degree of ablation and coagulation in tissue, which can lead to a greater tissue response in terms of fibroblast activity, collagen remodeling, and new collagen formation.

J Drugs Dermatol. 2017;16(11):1085-1090.

A Prospective Study of Axillary Hair Reduction in Patients Treated With Microwave Technology.

BACKGROUND: Removing unwanted body hair is a growing trend in society today, and there are many laser-based devices for hair reduction. There are some limitations to those methods, including the lack of efficacy for lighter color hair. OBJECTIVE: The objective was to quantify hair reduction in the axillae after treatment with a noninvasive microwave energy device. MATERIALS AND METHODS: A prospective, multicenter study was performed at 3 private dermatology clinics. Fifty-six adult subjects seeking axillary hair reduction were enrolled and treated with the device in 1 or 2 treatment sessions 3 months apart at various energy levels, and followed for 12 months. The primary analysis was monitoring reduction of hair counts from baseline to follow-up visits. A subject assessment of overall satisfaction, odor ratings, and sweat reduction ratings was provided at follow-up visits. RESULTS: Fifty-six subjects received treatment, with an average total underarm hair reduction of approximately 70% for both light and dark hair. Percentage of patients with hair reduction of 30% or more was significantly higher than 50% at all follow-up visits. Half of treated subjects reported expected mild transient post-treatment effects such as localized edema, discomfort, and bruising. Other reported events were mild. CONCLUSION: This clinical study provides evidence for safe and permanent axillary hair reduction, showing stable average reduction that lasted through the year of follow-up. Most notably, the study has shown the treatment's efficacy for reduction of light-colored axillary hair.

Evaluation of Micro-Focused Ultrasound for Lifting and Tightening Neck Laxity.

BACKGROUND: A novel device using micro-focused ultrasound with high-resolution ultrasound visualization (MFU-V) produces non-invasive lifting and tightening of lax skin on the face and neck when treatment is delivered at a single focal depth (Ulthera® System; Ulthera, Inc., Mesa, AZ).
OBJECTIVE: The following study was performed to test the hypothesis that customized application of MFU-V at two focal depths will produce clinical results that are superior to treatment at a single focal depth.
METHODS AND MATERIALS: Adult subjects (N=71) with skin laxity in the lower face and neck were enrolled; 64 met all entrance criteria and received treatment. On the basis of physical and anatomical characteristics, patients were assigned in nonrandomized fashion to one of three treatment groups to undergo treatment on the submental, submandibular, lower neck, and platysmal areas with MFU-V at single or dual depths.
RESULTS: Among evaluable subjects (N=64), investigator-assessment and subject-self-assessment demonstrated improved aesthetic changes at 60, 90, and 180 days after treatment. Overall, subjects that received MFU-V at two focal depths to the entire treatment area achieved slightly greater aesthetic improvement than subjects receiving MFU-V at single focal depths. There were no unexpected adverse events.
CONCLUSION: Applying treatment with MFU-V at two focal depths may provide improved aesthetic results in some subjects.

J Drugs Dermatol. 2016;15(5):607-614.

Comparative Study of Professional vs Mass Market Topical Products for Treatment of Facial Photodamage.

BACKGROUND: Many over the counter topical products claim to reverse the signs of cutaneous photo-damage. To date, the two most studied ingredients for improving the texture, tone, and pigmentation of the skin are topical retinoids and hydroquinone. OBJECTIVE: This split face study compares a mass market skincare regimen with a prescription skin care regimen for improvement in photo damaged skin. METHODS: Twenty-seven subjects with moderate photo damaged facial skin were enrolled. Each subject was consented and assigned with the mass market anti-aging system (Treatment A) to one side of the face and the prescription anti-aging system (Treatment B or Treatment C) to the other side of the face. Treatment B contained 13 subjects whom did not use 0.025% Retinol cream. Treatment C contained 14 subjects who used a 0.025% Retinol Cream. Subjects had 4 visits over 12 weeks for digital photography and surveys. Photographs were evaluated by blinded physicians. RESULTS: Physician objective analysis showed all three systems to have a statistically significant clinical improvement in photoaged skin seen in as little as 4 weeks of use. Participant's surveys rated the mass market system higher than both of the professional systems for visible skin changes, ease of use, and likelihood to recommend to a friend. Twelve of twenty-seven subjects preferred the mass market system for overall improvement while twelve thought each system gave the same improvement. CONCLUSION: This study demonstrates that a mass marketed skin care system can give similar clinical improvements in photo-aged skin as a professionally dispensed prescription system and the majority of participants preferred the mass-marketed system.

Safety and efficacy of cryolipolysis for non-invasive reduction of submental fat.

BACKGROUND AND OBJECTIVES: Cryolipolysis has previously received FDA clearance for fat reduction in the abdomen, flanks, and thighs. There is also interest in small volume fat reduction for areas such as the chin, knees, and axilla. This article reports the results of a cryolipolysis pivotal IDE study for reduction of submental fullness. STUDY DESIGN/MATERIAL AND METHODS: A prototype small volume vacuum applicator (CoolMini applicator, CoolSculpting System, ZELTIQ Aesthetics) was used to treat 60 subjects in the submental area. At each treatment visit, a single treatment cycle was delivered at -10°C for 60 minutes, the same temperature and duration used in current commercially-available cryolipolysis vacuum applicators. At the investigator's discretion, an optional second treatment was delivered 6 weeks after the initial treatment. The primary efficacy endpoint was 80% correct identification of baseline photographs by independent physician review. The primary safety endpoint was monitoring incidence of device- and/or procedure-related serious adverse events. Secondary endpoints included assessment of fat layer thickness by ultrasound and subject satisfaction surveys administered 12 weeks after final cryolipolysis treatment. RESULTS: Independent photo review from 3 blinded physicians found 91% correct identification of baseline clinical photographs. Ultrasound data indicated mean fat layer reduction of 2.0 mm. Patient questionnaires revealed 83% of subjects were satisfied, 80% would recommend submental cryolipolysis to a friend, 77% reported visible fat reduction, 77% felt that their appearance improved following the treatment, and 76% found the procedure to be comfortable. No device- or procedure-related serious adverse events were reported. CONCLUSION: The results of this clinical evaluation of 60 patients treated in a pivotal IDE study demonstrate that submental fat can be reduced safely and effectively with a small volume cryolipolysis applicator. Patient surveys revealed that submental cryolipolysis was well-tolerated, produced visible improvement in the neck contour, and generated high patient satisfaction. These study results led to FDA clearance of cryolipolysis for submental fat treatment.

Treatment of Facial Photodamage With Mass Market Topical Products vs Non-ablative Fractional Laser.

METHODS: In this split-face, evaluator-blinded study, 18 subjects were randomly assigned to receive either the SSR or NFL treatments on each side of the face. For the SSR facial sides subjects followed two morning-evening regimens. On the NFL sides subjects were treated 3 times with the 1927-nm laser at 4-week intervals. Three physician evaluators were asked to rate hyperpigmentation, global photoaging, and ne lines and wrinkles for each side of the face at baseline and at 3 months using a 5-point scale. RESULTS: The SSR and NFL treatments provided comparable results for each skin attribute. Improvement from baseline was signi - cant in both treatment programs for each skin attribute. The greatest 3-month improvement for both programs was in hyperpigmen- tation. For global photoaging and ne lines and wrinkles, positive responses were slightly greater in the NFL than in the SSR facial sides. Subject preference for the SSR over the NFL was greatest for ne lines around the eyes, ne lines around the mouth, smooth texture, radiant complexion, and overall improvement while the NFL was preferred for skin rmness and evenness. When the study was completed5 of 18 split-face subjects decided to undergo NFR laser treatment on the non laser treated side along with using the SSR product and 13 of the 18 subjects continued to use the SSR products to their full face after the study. CONCLUSION: The mass market skin care system of the present study provides improvement in hyperpigmentation, global photoaging, and ne lines and wrinkles comparable to that of a series of treatments with a non-ablative fractional laser. J Drugs Dermatol. 2016;15(11):1366-1372..

Evaluation of a novel home skin care platform.

The home beauty device market is rapidly growing, having more than tripled in the last four years. This study evaluates several specific attachment heads using a novel home skincare platform (HSP). By incorporating multiple treatment heads for cleansing, skin smoothing, and skin infusion, this device has the potential to address many potential treatment goals. The first subset of this study is a blinded, randomized split-face study evaluating the efficacy of the HSP device with a standard brush head for make-up removal and compares the HSP device to a currently marketed home cleansing device. The results show that the HSP cleansing head was comparable to the leading home skin cleansing device on the market. The HSP's skin smoothing head showed statistically significant improvement in erythema and dryness over baseline levels with significant histologic changes including normalization of epidermal thickness in only 10 days of use. This is comparable to and exceeds many well-studied antiaging treatments after weeks and months of therapy. Finally, the infusion head demonstrated improvement in skin hydration over baseline levels.

Cryolipolysis for safe and effective inner thigh fat reduction.

BACKGROUND AND OBJECTIVES: While cryolipolysis initially received FDA clearance for fat reduction in the abdomen and flanks, there was significant interest in non-surgical fat reduction for other sites, such as the inner and outer thighs. This article reports the results of an inner thigh study which contributed to FDA clearance of cryolipolysis for treatment of thighs. STUDY DESIGN/MATERIAL AND METHODS: A flat cup vacuum applicator (CoolFit applicator, CoolSculpting System) was used to treat 45 subjects bilaterally in the inner thighs. Single cycle treatments were delivered at Cooling Intensity Factor (CIF) 41.6 for 60 minutes followed by 2 minutes of manual massage. Follow-up visits were conducted at 8 and 16 weeks. Efficacy was assessed by ultrasound imaging, circumference measurements, and photographs. Safety was assessed by monitoring adverse events. Patient satisfaction was evaluated by questionnaire. RESULTS: Data is presented for n = 42 patients that completed the 16 week study follow-up and maintained their weight within 5 lbs. of baseline. Independent photo review from three blinded physicians found 91% correct identification of baseline clinical photographs. Ultrasound data indicate fat layer reduction of 2.8 mm. Circumferential measurements indicate mean reduction of 0.9 cm. Patient questionnaires reveal 93% were satisfied with the CoolSculpting procedure; 84% noticed visible fat reduction; 89% would recommend to a friend; and 91% were likely to have a second treatment. There were no device- or procedure-related serious adverse events. CONCLUSION: The CoolFit flat cup vacuum applicator was found to deliver safe and effective cryolipolysis treatment to reduce inner thigh fat. Completed 16-week data from 42 subjects show 2.8 mm reduction in fat thickness and 0.9 cm reduction in circumference. Assessment of clinical photographs found 91% correct identification of baseline images. The results of this prospective, multi-center, interventional clinical study contributed to FDA clearance of cryolipolysis for treatment of thighs in April 2014.

A randomized comparison of the efficacy of low volume deep placement cheek injection vs. mid- to deep dermal nasolabial fold injection technique for the correction of nasolabial folds.

BACKGROUND: Hyaluronic acid (HA) fillers are FDA approved for improving the appearance of the nasolabial folds. Previous reports on the use of HA for this treatment have focused on injections directly into the location of the desired correction. To our knowledge, a study has not been done evaluating the efficacy of injecting a low volume of HA into the adjacent area of volume loss to correct both volume loss and adjacent lines. OBJECTIVE: The objective of this study was to compare the effectiveness and safety of three HA injection protocols including deep dermal cheek injection, mid- to deep dermal local nasolabial fold injection, and both injections for the correction of nasolabial folds. METHODS: This was a split-face, randomized study evaluating the use of three injection techniques - (i) deep bolus injection into the mid- to lateral cheek, (ii) local mid- to deep dermal injection into the nasolabial fold, and (iii) both deep injection into the mid- to lateral cheek and local mid- to deep dermal injection into the nasolabial fold - for the treatment of moderate to severe nasolabial folds. Wrinkle severity and Global Aesthetic Improvement Scales were measured before and 4-6 weeks after treatment as assessed by a blinded investigator. RESULTS: Patient and physician observations showed improvement both globally and in wrinkle severity score with each technique used with no statistical difference between techniques. Patients showed a slight preference for injection to both the mid- to lateral cheek and nasolabial fold, which was associated with the greatest amount of filler product administered. No serious adverse events were reported. CONCLUSION: Injection of a dermal filler, at low volumes, into either the nasolabial fold or mid- to lateral cheek results in similar improvement to the correction of the nasolabial folds.

Complications in cosmetic laser surgery: a review of 494 Food and Drug Administration Manufacturer and User Facility Device Experience Reports.

BACKGROUND: Complications in cosmetic laser and energy based surgery affect a number of patients every year and may cause scars, burns, blisters, and pigmentation damage. OBJECTIVE: To evaluate documented complications in cosmetic laser- and energy-based surgeries, determine the most common errors, and recommend a simple procedural sequence to reduce patient complications. MATERIALS AND METHODS: U.S. Food and Drug Administration Manufacturer and User Facility Device Experience Adverse Event Reports after cosmetic laser- and energy-based procedures with varied devices were reviewed (N = 494). The laser manufacturer, device used, event type, injury type, cause, operator, and indication for treatment for each case were identified. RESULTS: In the 494 cases reviewed between 2006 and 2011, the most common complications were burns, scarring, blistering, pigmentation damage, and infection. The most common cause of these complications was user error by a healthcare provider (30%), followed by laser device malfunction (20%) and patient error (4%). Indications for treatment were unknown for 69% of cases, and 38% of the cases were an unknown cause of complication. CONCLUSIONS: User error was a major factor in laser surgery complications. To improve safety and reduce errors, we propose the implementation of a procedural sequence for cosmetic laser surgery.

Home hair removal in all skin types with a combined radiofrequency and optical energy source device.

BACKGROUND: Home hair removal devices are available for skin types I to IV. Side effects may limit hair removal in darker-pigmented individuals. OBJECTIVE: To evaluate a home hair removal device using combined radiofrequency (RF) and intense pulsed light (IPL) energy for effectiveness and safety with all skin types (I-VI). DESIGN: Two study designs: effectiveness (treating 94 bilateral patient areas weekly seven times, with one side then receiving three additional treatments at 4-week intervals) and safety (37 patient areas treated every 2-4 days for three sessions). MEASUREMENTS: Hairs were counted 3 months after treatment for the first design and 2 months after for the second. RESULTS: In the first study design, 55% hair count reduction was achieved1 month after seven treatments to all sites. The side with no further sessions had 43% hair reduction and the side receiving ongoing treatment had 58% reduction after two further treatments. Side effects were transient and minor. In the second study, with 46% of the patients having skin types V/VI, 2 months after the procedure there was 44% hair reduction. There were no adverse effects reported. CONCLUSION: For the first time, a home hair removal device has been shown to be effective and safe in all skin types using a low-energy RF-IPL device.

Minimally ablative resurfacing with the confluent 2,790 nm erbium:YSGG laser: a pilot study on safety and efficacy.

BACKGROUND: The 2,790 nm Er:YSGG wavelength has a lower water absorption coefficient than the 2,940 nm Er:YAG, but a higher coefficient than the 10,600 nm CO(2) laser. This allows ablative resurfacing with mild thermal coagulation, which may increase clinical efficacy while reducing patient downtime. OBJECTIVES: To evaluate the efficacy and safety of the confluent 2,790 nm Erbium:YSGG (Pearl™, Cutera) laser for facial rejuvenation. STUDY DESIGN/MATERIALS AND METHODS: Eleven subjects (mean age 50, skin types I-III) with mild to moderate photodamage and wrinkles had two facial treatments with the 2,790 nm Er:YSGG laser using a fluence of 3.5 J/cm(2), pulse duration of 0.4 msecond, and 20% overlap. Treatments were performed 6 weeks apart. Pre-auricular biopsies from five subjects were evaluated at baseline and 6 weeks after the final treatment. Data from blinded photo assessments and subjects' self-assessment of improvement were analyzed 6 weeks after the final treatment. Additionally, long-term safety and efficacy were evaluated 2 years after the final treatment. RESULTS: Histologically, 80% of subjects had new collagen formation in the dermal grenz zone, and 60% had increased epidermal thickness. Almost all subjects (91%) showed improvement in tone/texture, 82% of subjects showed improvement in dyschromia and fine lines, and 54% showed improvement in wrinkles 6 weeks after the final treatment. Subjects' self assessment indicated "significant" to "dramatic" improvement in dyschromia (91% of subjects) and tone/texture (82%) 6 weeks after the final treatment. All subjects saw "mild" to "significant" improvement in fine lines and wrinkles. At the 2-year follow-up visit, 57% of the overall improvement achieved at 6 weeks was maintained. No adverse events were reported throughout the study. CONCLUSION: Ablative resurfacing with the 2,790 nm Er:YSGG laser demonstrated visible improvement in photodamage with good tolerability and minimal downtime. Subjects were highly satisfied, especially with respect to dyschromia, skin tone, and texture.

A randomized controlled trial of fractional laser therapy and dermabrasion for scar resurfacing.

BACKGROUND: Dermabrasion has been the standard resurfacing procedure for postsurgical scars, but recovery can be long. Fractionated carbon dioxide (CO2 ) laser is a safe, effective tissue resurfacing modality, but no prospective trial has compared its safety or efficacy with that of dermabrasion for postsurgical scar resurfacing. OBJECTIVE: To compare the safety and efficacy of single-treatment fractional photothermolysis with that of single-treatment dermabrasion for postsurgical scar resurfacing on the face. METHODS AND MATERIALS: A split-scar method was used to compare fractionated CO2 laser and diamond fraise dermabrasion on postsurgical scars of the face. Primary endpoint was safety at day 0, 1 week, and 1 month. Secondary endpoint was efficacy at 3 months as measured by blinded evaluation of standardized photographs. RESULTS: Safety data revealed that there was less erythema (p = .001) and bleeding (p = .001) at day 0, less erythema (p = .01) and edema (p = .046) at 1 week, and a trend toward less erythema at 1 month (p = .06) with fractionated CO2 . Efficacy data at 3 months revealed equivalent scar improvements (p = .77). CONCLUSION: Fractionated CO2 laser therapy should be considered a safe alternative for surgical scar resurfacing on the face. The safety profile exceeds that of dermabrasion, and it has a quicker clinical recovery and equivalent cosmetic efficacy.

Survey of regional laser centers: a Minnesota perspective.

BACKGROUND: Laser use in medicine is rapidly expanding as patients seek treatment for medical and cosmetic purposes. Concern is mounting about the unsupervised use of lasers and similar devices by nonphysician personnel. Minnesota is currently one of the few states with no legislation regarding the uses of lasers. OBJECTIVE: To determine whether laser centers in Minnesota meet professional standards and guidelines for patient safety. METHODS AND MATERIALS: Public resources were used to identify all businesses with laser services in Minnesota cities with a population of at least 1,000 people. Each laser center was contacted, and a "secret shopper," a person who posed as a potential patient administered a telephone survey. RESULTS: A wide range of physicians and nonphysician personnel offer laser services in Minnesota. Supervision was not standardized and varied widely across the laser centers. CONCLUSIONS: As the demand for laser services increases, the use of lasers must be clearly defined and regulated to prevent patient injury. The authors have indicated no significant interest with commercial supporters.