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.

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.

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 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.

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.

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.

Histologic analysis of a 2,940 nm fractional device.

BACKGROUND AND OBJECTIVES: An evaluation of the histological effects of a 2,940 nm fractional erbium:YAG (Er:YAG) laser device with adjustable depth and coagulation settings in a human abdominoplasty model. The goal of this study was to use light and confocal microscopy to determine the dimensions of the microthermal zones (MTZs) created by this device in the epidermal and dermal layers. STUDY DESIGN/MATERIALS AND METHODS: Three subjects were consented and treated after being randomly assigned to a laser depth of either 250 µm, 500 µm, or 1,000 µm. Four coagulation levels were tested in each subject. Two biopsies were taken immediately, 1 and 2 weeks post-treatment from each zone and viewed by light and confocal microscopy. Two blinded observers examined the sections for changes in collagen and measured depth and width of the MTZs. Coagulation was assessed and recorded as the depth and width of denaturation; measured as the depth and width of ablation plus surrounding thickness of thermal necrosis from dissipated heat. RESULTS: Light microscopy findings in all treated samples showed a perforated epidermis and dermis immediately after treatment. The depths of ablation produced did not accurately reflect the three different laser settings. Depths of denaturation also did not increase with increased coagulation level settings as expected. The width of ablation in the MTZs, a non-adjustable setting, was the most accurate and reproducible in all subjects. Confocal microscopy samples revealed the presence of collagen remodeling in the dermis, which increased significantly at 1 and 2 weeks post-treatment. CONCLUSIONS: Treatment with the 2,940 nm Er:YAG device led to significant changes of the dermis at light microscopy levels. The adjustable laser depth and coagulation settings did not produce predictable depths of ablation or denaturation, possibly as a result of the variation of tissue hydration properties among individuals. Increased collagen remodeling was seen in the dermis in all subjects at 1 and 2 weeks post-treatment.

Efficacy of a multiple diode laser system for body contouring.

BACKGROUND AND OBJECTIVES: Low-level laser therapy (LLLT) has been shown to induce cellular reactions in nonphotosynthetic cells however skepticism remains regarding efficacy at the clinical level. The purpose of this study was to evaluate the efficacy of LLLT independent of liposuction. Additionally, a weight loss supplement (Curva™, Santa Barbra Medical Innovations, Santa Barbra, CA) was evaluated. This clinical trial evaluates the effectiveness of the Erchonia EML Laser (Zerona™ System, Santa Barbra Medical Innovations) for non-invasive fat reduction and body contouring in a split-body clinical evaluation. MATERIALS AND METHODS: Five subjects were enrolled and completed the study. Subjects had a body mass index (BMI) of less than or equal to 29 kg/m(2) and satisfied the set inclusion criteria. Participants were randomly assigned to receive low-level laser treatments on one side of the body three times per week for 2 weeks. One group took the weight loss supplement and was also treated with the laser. Subject satisfaction questionnaires, physician blinded photo evaluation, circumference measurements and ultrasound measurements were utilized to evaluate efficacy. RESULTS: Circumference measurements revealed no statistically significant reduction at either 7 days or 1 month post-treatment. One month following treatment the greatest circumference reduction overall was 0.5 ± 0.3 inches. Ultrasound measurements also did not reveal statistically significant reduction in fat layer thickness (P > 0.5). Evaluation by three blinded dermatologists resulted in average correct photo identification of 51.1%. Results reflect little clinical difference between post-treatment and baseline images. Three subjects recording a "dissatisfied" rating on satisfaction questionnaires and all subjects reported the effects of the treatment were less than expected. Subjects who took the weight loss supplement had no greater circumference reduction or identifiable clinical outcome. CONCLUSIONS: This small study demonstrates to the authors that there needs to be more evidence to show clinical circumferential reduction before LLLT can be recommended as an effective therapeutic option.

Clinical study to determine the safety and efficacy of a low-energy, pulsed light device for home use hair removal.

BACKGROUND AND OBJECTIVES: The principle of selective photo-thermolysis has been studied extensively for hair removal applications in a medical setting. A new, portable, hand-held device featuring two filtered Xenon lamps that utilizes pulsed light in low optical fluencies for hair removal has been developed for consumer use. The purpose of this clinical study was to determine the efficacy and safety of this low-energy, pulsed-intense light device intended for home use hair removal. STUDY DESIGN/ MATERIALS AND METHODS: The treatment group consisted of 10 adults with skin types I-IV who possessed unwanted dark hair in the non-facial region. The subjects received between 4 and 6 treatments on a bi-weekly basis with the device by a trained member of the clinical staff. The clinical responses were evaluated by performing manual hair counts using magnified vision and photographs which were obtained prior to treatment and at each subsequent visit. RESULTS: Mean hair reduction was 36% 4 weeks after the final treatment and 10% 12 weeks after the final treatment. This resulted in a mean hair count reduction of 23% over the two follow-up appointments. There was no definitive correlation between customer satisfaction and hair count reduction. Adverse reactions were limited to transient, localized, post-treatment erythema. No complications were encountered. CONCLUSIONS: This low-energy, pulsed-light device is a quick, safe, and relatively effective at-home hair reduction treatment option in patients with various skin phototypes.

Discussion of laser-assisted liposuction.

UNLABELLED: There has been a significant advancement in the use of lasers for body contouring over the past several years. This article will review the recent past and discuss the future of this trend. INTRODUCTION: There is much confusion over the definition of procedures using lasers for lipolysis and liposuction. This review article discusses the definitions of suction-assisted liposuction, laser lipolysis, and laser-assisted liposuction in detail. The development of these procedures is then discussed and pertinent articles are reviewed. MATERIALS AND METHODS: Pubmed and FDA.gov web sites were searched for published articles and FDA approved devices employing lasers for targeting fat for body contouring. This information along with the authors' personal experience was used to review and discuss this topic. DISCUSSION: There is a specific difference between suction-assisted liposuction, laser-assisted liposuction, and laser lipolysis. This review article clarifies these definitions and highlights the recent articles employing lasers for minimally invasive fat reduction.

Semi-Automated method of analysis of horizontal histological sections of skin for objective evaluation of fractional devices.

BACKGROUND AND OBJECTIVE: The treatment of skin with fractional devices creates columns of micro-ablation or micro-denaturation depending on the device. Since the geometric profiles of thermal damage depend on the treatment parameters or physical properties of the treated tissue, the size of these columns may vary from a few microns to a few millimeters. For objective evaluation of the damage profiles generated by fractional devices, this report describes an innovative and efficient method of processing and evaluating horizontal sections of skin using a novel software program. MATERIALS AND METHODS: Ex vivo porcine skin was treated with the Lux1540/10, Lux1540 Zoom and Lux2940 with 500 optics. Horizontal (radial) sections of biopsies were obtained and processed with H&E and NBTC staining. Digital images of the histologic sections were taken in either transmission or reflection illumination and were processed using the SAFHIR program. RESULTS: NBTC- and H&E-stained horizontal sections of ex vivo skin treated with ablative and non-ablative fractional devices were obtained. Geometric parameters, such as depth, diameter, and width of the coagulated layer (if applicable), and micro-columns of thermal damage, were evaluated using the SAFHIR software. The feasibility of objective comparison of the performance of two different fractional devices was demonstrated. CONCLUSION: The proposed methodology provides a comprehensive, objective, and efficient approach for the comparison of various fractional devices. Correlation of device settings with the objective dimensions of post-treatment damage profiles serve as a powerful tool for the prediction and modulation of clinical response.

Evaluation of a novel fractional resurfacing device for treatment of acne scarring.

BACKGROUND AND OBJECTIVE: Pulsed carbon dioxide (CO(2)) laser devices are considered highly effective treatment options for skin resurfacing. However, the high risk for significant treatment complications following CO(2) resurfacing has warranted the development of new treatment modalities. The concept of fractional photothermolysis was developed to address the shortcomings of ablative and non-ablative device modalities. This report evaluates a fractional approach to CO(2) laser resurfacing for the treatment of moderate to severe acne scarring. The primary endpoint of the study was the overall improvement in the appearance of acne scarring. STUDY DESIGN/MATERIALS AND METHODS: Thirty subjects, with moderate to severe acne scarring, underwent up to three treatments with an FDA IDE and IRB approved 10,600 nm fractional CO(2) laser system. All subjects were Fitzpatrick skin types I-V and 18-75 years of age. Treatment parameters ranged from 20 to 100 mJ with total densities of 600-1,600 MTZ/cm(2). Improvement of acne scarring was evaluated at 1 and 3 months post-treatment. RESULTS: Twenty-three out of 25 subjects sustained clinical improvement in the appearance of acne scarring at the 3-month follow-up visits according to study investigator quartile improvement scoring. Subjects also had improvement in their overall appearance, including pigmentation and rhytides. Serosanguinous oozing resolved within 24-48 hours following treatment. All subjects had transient erythema, which resolved in the majority of subjects within 1-3 months. Post-operative downtime was significantly decreased compared to traditional ablative resurfacing. No serious complications were reported. CONCLUSION: Fractional deep dermal ablation improves moderate to severe acne scarring. The added benefit is a considerable reduction both in downtime and risk of complications when compared to traditional CO(2) ablative resurfacing techniques.

The use of photodynamic therapy in dermatology: results of a consensus conference.

Photodynamic therapy (PDT) has significant promise in improving outcomes of patients with a variety of cutaneous conditions. A group of experts met to review the principles, indications, and clinical benefits of PDT with 5-aminolevulinic acid (ALA). They also reviewed PDT with methyl aminolevulinate. The experts established consensus statements for pretreatment, posttreatment, ALA contact time, light sources, and numbers of sessions associated with ALA PDT for actinic keratosis and superficial basal cell carcinoma, photorejuvenation and cosmetic enhancement, acne, sebaceous skin, rosacea, and rhinophyma. They based consensus recommendations on their clinical experience and the medical literature. They also suggested future applications of ALA PDT. Experts concluded that ALA PDT is a safe and effective modality for the treatment of conditions commonly encountered in dermatology. Since downtime is minimal, the technique is suitable for patients of all ages and lifestyles. Appropriate light sources are available in many dermatology offices. The expanding clinical and financial benefits of PDT justify the purchase of an appropriate light source.

Treatment of inflammatory facial acne with the 1,450 nm diode laser alone versus microdermabrasion plus the 1,450 nm laser: a randomized, split-face trial.

BACKGROUND: The 1,450 nm laser has been effective in treating acne. Microdermabrasion may help treat acne and reduce skin barriers to increase the delivery rate of topical anesthetics. OBJECTIVES: To evaluate the efficacy, safety, and pain associated with the treatment of inflammatory facial acne with the 1,450 nm laser alone versus microdermabrasion plus the 1,450 nm laser. METHODS: Twenty patients with facial acne were treated with the 1,450 nm laser alone and microdermabrasion plus the 1,450 nm laser in a randomized, split-face trial. RESULTS: Laser alone and microdermabrasion plus laser significantly reduced the total number of acne lesions. Mean reductions of 53.5% and 55.6% were found after three treatments for laser alone and microdermabrasion plus laser, respectively. Clinical improvement was maintained 12 weeks after the last treatment. Mean pain scores were 5.3 6 1.5 for microdermabrasion plus laser and 5.2 6 1.5 for laser alone. There was no statistical difference between treatment levels for efficacy or pain. There was an average 10% increase in sequential pain as the laser treatment progressed. CONCLUSION: The 1,450 nm laser is effective, well tolerated, and safe for treating facial acne. This small pilot study did not demonstrate increased clinical efficacy or decreased associated pain with the addition of microdermabrasion to treatment with the 1,450 nm laser. A larger study may be needed to demonstrate any additional benefit.

Complications of laser dermatologic surgery.

BACKGROUND AND OBJECTIVE: Innovations in lasers, light and radiofrequency devices have allowed for improved therapeutic efficacy and safety and the ability to treat patients with an ever-increasing number of medical and aesthetic indications. Safety remains a primary concern and the timely communication of complications and their management is vital to insure that treatments be as safe as possible. The purpose of this report on the Proceedings of the First International Laser Surgery Morbidity Meeting is to provide laser experts the opportunity to present and discuss complications that their patients have experienced and how they were successfully managed. METHODS: Laser experts were invited to present complications of laser, light, and radiofrequency treatments that their patients have experienced and to discuss the potential mechanisms leading to the complications their management and final outcomes. RESULTS: Nineteen unique cases are presented and the clinical management of each case discussed. Eighteen sets of pre- and post-operative photos are presented. CONCLUSION: This report shows that even experts, with extensive experience using light-based therapies, can and do have patients who develop complications. Sound clinical judgment, and knowing how to avoid complications and their timely post-operative management, is essential to insure optimal therapeutic outcome.

Radiofrequency treatment for middle and lower face laxity.

OBJECTIVE: To compare the effectiveness of 1 and 2 radiofrequency (RF) treatments with the ThermaCool TC system (Thermage Inc, Hayward, Calif) on middle and lower face laxity. METHODS: Twenty patients with mild to moderate laxity of the middle and lower face were randomly assigned to receive either a single RF treatment or 2 treatments spaced 1 month apart. Treatment energy levels were titrated to patient tolerance and ranged from 85 to 135 J/cm(2). Acute clinical response was recorded after each session. Standardized photographs were taken before treatment and at 1 and 4 months after the last treatment. Using a percentage scale, 4 blinded physicians experienced in dermatologic laser therapy independently rated improvement in nasolabial folds, marionette lines, jowls, laxity under the chin, and overall appearance. In addition, subjects completed quality-of-life surveys 1 and 4 months after treatment. Each patient paid the same fee for involvement in the study. RESULTS: Eleven patients received a single RF treatment, and 9 patients underwent 2 treatments. All subjects experienced mild edema and mild to moderate erythema as an acute clinical response; no patients experienced burns, skin breakdown, or scarring. At 4-month follow-up, patients in the 2-treatment group received higher scores in all categories of photographic analysis; the difference in improvement in the nasolabial folds was statistically significant (P = .04). In self-assessment ratings, individuals receiving 2 treatments reported more improvement than subjects in the single-treatment group 4 months after treatment (P = .03). In both treatment groups, physician photographic assessment demonstrated continued improvement in all subsites between the 1-month and 4-month assessments (P<.05). Although the overall change noted by both patients and physicians was modest in most patients, 75% of subjects (n = 15) stated they would consider paying for additional treatments. CONCLUSIONS: Two RF treatments yielded significantly better improvement than a single treatment in the nasolabial folds. Significant improvement in laxity after treatment was seen between the 1- and 4-month follow-up visits in both single- and 2-treatment groups. Although overall improvements were modest in both groups, patient satisfaction was relatively high.

Confocal microscopy study of nerves and blood vessels in untreated and treated port wine stains: preliminary observations.

BACKGROUND AND OBJECTIVE: Vascular ectasia in port wine stain birthmarks (PWS) might result from reduced innervation with loss of autonomic stimulation. We investigated this theory and evaluated nerve and blood vessel density, and mean blood vessel size in untreated and treated PWS skin. METHODS: Skin biopsy specimens were obtained from uninvolved skin, untreated PWS, PWS with a good response to laser treatment and PWS with a poor response to laser treatment. Confocal microscopy was performed to determine nerve and blood vessel density, and mean blood vessel size. RESULTS: Nerve density was significantly decreased in all PWS sites compared to uninvolved skin. Mean blood vessel diameter was larger in untreated compared to treated PWS. PWS with a good response to treatment had decreased nerve density but blood vessel density and mean diameter was relatively normal. PWS with a poor response to treatment had decreased nerve density but increased blood vessel density and mean blood vessel diameter compared to normal skin. CONCLUSION: Nerve density was decreased in all evaluated PWS sites and this may be a factor in lesion pathogenesis. PWS blood vessel size correlated with pulsed dye laser response and may prove to be a useful prognostic indicator of therapeutic outcome.

Histological and ultrastructural evaluation of the effects of a radiofrequency-based nonablative dermal remodeling device: a pilot study.

BACKGROUND: Many light- and laser-based systems are used to reduce cutaneous wrinkles, and some have been shown to stimulate dermal collagen production. Using the ThermaCool TC radiofrequency device to treat bovine tendon and human abdominal skin, we documented the cutaneous effects of a radiofrequency-based system for nonablative treatment. OBSERVATIONS: Electron microscopy of bovine tendon treated at varied heat and cooling settings revealed collagen fibrils with increased diameter and loss of distinct borders as deep as 6 mm. Human skin treated at varied heat and cooling settings and examined by means of routine light microscopy demonstrated no significant changes in the epidermis or dermal ground substance immediately after treatment; there was scattered mild perivascular and periadnexal inflammation. Three and 8 weeks after treatment, no observable changes were noted. Ultrastructural analysis, however, disclosed isolated, scattered areas of collagen fibrils with increased diameter and loss of distinct borders. In addition, Northern blot analysis demonstrated an increase in collagen type I messenger RNA steady-state expression. CONCLUSIONS: Our findings suggest that collagen fibril contraction occurs immediately after treatment and gives rise to tissue contraction and thermally mediated wounding, which induces new collagen production.

Full-face laser resurfacing using a supplemented topical anesthesia protocol.

BACKGROUND: Laser resurfacing has become a popular modality for the treatment of photodamaged skin, rhytids, and acne scarring. In many cases, this procedure is performed under general anesthesia or intravenous sedation in conjunction with nerve blocks and local infiltration. OBJECTIVE: To evaluate the safety and efficacy of facial carbon dioxide laser resurfacing using a supplemented topical anesthesia protocol. DESIGN: Nonrandomized case series of patients observed for 1 year. SETTING: Outpatient surgery center. PATIENTS: Two hundred consecutive patients undergoing treatment for facial rhytids or acne scarring. Intervention Full-face carbon dioxide laser resurfacing procedures were performed using a supplemented topical anesthesia protocol. Pretreatment medications included diazepam, oral analgesics, and intramuscular ketorolac tromethamine. MAIN OUTCOME MEASURES: Tolerability of procedure, healing times, and adverse effects. RESULTS: Topical anesthesia provided effective and sufficient anesthesia in most cases. Only 10 of 200 patients required additional anesthesia (regional nerve blocks and/or local infiltration). Substantial improvement of rhytids, photodamage, and acne scarring was observed. Posttreatment hypopigmentation was seen in 1 patient. Scarring was not observed. Conclusion A supplemented topical anesthesia protocol for full-face laser resurfacing is a safe and effective alternative to traditional anesthesia strategies.