Successful and safe use of Q-switched lasers in the treatment of nevus of Ota in children with phototypes IV-VI.

OBJECTIVE: Nevus of Ota represents congenital dermal melanocytosis in a trigeminal distribution, most commonly occurring in Asian individuals and other individuals with skin of color. Evidence suggests early treatment is beneficial. Multiple reports have shown efficacy and safety of Q-switched laser treatment in adults. There is little data on children and in non-Asian skin types. This series was done to demonstrate safe and effective use of Q-switched laser therapy in children of multiple skin types. STUDY DESIGN: Retrospective case series. METHODS: This was a chart review of patients under 18 years old who presented to our practice from 2002 to 2015 with a clinical diagnosis of nevus of Ota who were treated with Q-switched lasers (694 and 1,064 nm). Patients were treated without the use of general anesthesia or sedation, and corneal shields were used in appropriate cases. Percentage of improvement as well as side effects were rated by five physicians independently. Improvement, when present, was rated in quartiles (1-25%, 26-50%, 51-75%, and 76-100% improvement). RESULTS: Twenty-four children were included. The average age at the start of treatment was 3.9 years old (range of 3 months to 12.4 years), and patients had Fitzpatrick skin types IV through VI. The mean number of treatments was 9.3. Assessment revealed excellent response (76-100% improvement) in 70% of patients and good to excellent response (51-100% improvement) in 86%. Two patients (8%) had post-inflammatory hyperpigmentation, one of whom also had focal hypopigmentation. CONCLUSION: Treatment of nevus of Ota with Q-switched lasers in children with skin of color, without general anesthesia or sedation, is safe and effective. Early intervention should be encouraged for better efficacy and to prevent psychosocial distress in later childhood and adulthood. Lasers Surg. Med. 50:56-60, 2018. © 2017 Wiley Periodicals, Inc.

Pulsed Dye Laser at Subpurpuric Settings for the Treatment of Pulsed Dye Laser-Induced Ecchymoses in Patients With Port-Wine Stains.

BACKGROUND: Post-procedure purpura is a major complaint of patients with port-wine stains (PWSs) treated with pulsed dye laser (PDL). OBJECTIVE: To assess the safety and efficacy of using PDL at nonpurpuric settings to treat ecchymoses that develop within PWSs after treatment with PDL. MATERIALS AND METHODS: Prospective, randomized, controlled study using 595-nm PDL for treatment of PWSs and laser-induced ecchymoses. Port-wine stains were treated in entirety at baseline. Two days later, ecchymoses on randomly selected half of the lesion were re-treated with PDL at subpurpuric settings. Treatment series was repeated 4 to 8 weeks later, and follow-up was at 1 month. Reduction in bruising and PWS clearance were assessed. Three masked evaluators graded clinical improvement using a 4-point scale (1 = 1%-25% improvement, 2 = 26%-50% improvement, 3 = 51%-75% improvement, and 4 = 76%-100% improvement). RESULTS: Twenty adults with 21 PWSs on the head, trunk, and extremities were treated. After first treatment, reduction of bruising was graded a mean value of 2.43 for the treatment side, compared with 1.93 for the control side (p = .012); after the second treatment, 2.83 compared with 2.40 (p = .021). No significant adverse events occurred. CONCLUSION: Pulsed dye laser can be used safely and effectively to reduce treatment-induced purpura in patients with PWSs.

Demographic and Tumor Characteristics of Patients Younger Than 50 Years With Nonmelanoma Skin Cancer Referred for Mohs Micrographic Surgery.

BACKGROUND: An increase in nonmelanoma skin cancer (NMSC) in younger patients has been reported. Many are treated with Mohs micrographic surgery (MMS). OBJECTIVE: Investigate patient and tumor characteristics in patients less than 50 years undergoing MMS for NMSC at a large, referral-based practice. METHODS & MATERIALS: Retrospective chart review of 1,332 tumors occurring in 1,018 consecutive patients over a five-year period. RESULTS: 81.7% of tumors were BCC and 55.3% occurred in women. Patients less than 30 years were more likely to be female (P equals 0.016) and women were more likely to have BCC (P equals 0.010). SCCs were more likely with increasing age (P less than 0.001). Of all tumors, 3.6% were recurrent, 2.7% had diameters ≥ 2 centimeters, and 5.5% of all BCCs had a high-risk histologic subtype. Women were more than twice as likely as men to be referred to plastic surgery for repair (P equals 0.020). CONCLUSION: Patients < 50 years with NMSC may represent a growing population referred for MMS, especially young women with BCC. High-risk tumor features were rare among young patients, and female gender was associated with an increased rate of referral for repair by a plastics subspecialty. Study was performed at the Laser & Skin Surgery Center of New York. IRB STATUS: Approved by Essex Institutional Review Board, Protocol #MOHS40-65

J Drugs Dermatol. 2018;17(5):499-505.

Treatment of recalcitrant port-wine stains (PWS) using a combined pulsed dye laser (PDL) and radiofrequency (RF) energy device.

BACKGROUND: Pulsed dye laser (PDL) is the treatment of choice for port-wine stains (PWS). Some PWS are recalcitrant to this modality. A number of reasons for PDL treatment resistance have been described, including inadequate heat generation. OBJECTIVE: We evaluated PDL combined with radiofrequency (RF) energy into a single device to target larger and deeper blood vessels and overcome PDL resistance. METHOD: This was an open-label, prospective, single-center investigation of a novel device combining RF energy with PDL conducted to treat recalcitrant PWS. Ten patients with 11 recalcitrant PWS were enrolled. Each PWS was divided into 5 treatment areas: PDL alone, RF alone, PDL+RF, RF+PDL, and untreated control. Patients underwent a maximum of 6 treatments, scheduled 4 to 6 weeks apart with follow-up evaluation at 4 and 12 weeks after the final treatment. Colorimetry and standardized digital photography were performed at all visits. Lesional biopsy specimens were collected for selected patients. RESULTS: Areas treated with RF followed by PDL and PDL followed by RF showed the greatest improvement based on blinded review of digital photographs, reaching statistical significance (P value < .05) at the 12-week follow-up evaluation when compared with baseline. Adverse events, including purpura, erythema, edema, scabbing, crusting, and blistering, resolved without sequelae; a small residual scar was noted in 1 patient. LIMITATIONS: Small sample size and short follow-up period are limitations. CONCLUSION: Combined RF/PDL technology is promising for the treatment of recalcitrant PWS.

Broader Practice Indications for Mohs Surgical Defect Healing by Secondary Intention: A Survey Study.

BACKGROUND: Recent reports have indicated secondary intention (SI) healing utilization for Mohs surgical defects beyond conventionally accepted indications. OBJECTIVE: To characterize potentially more expansive guidelines for when SI healing is indicated or appropriate in dermatologic surgery. METHODS: A survey study was e-mailed to the American College of Mohs Surgery in 2015. A group of 293 respondents addressed factors influencing decisions to heal surgical defects secondarily. RESULTS: The most experienced surgeons were significantly more likely to heal deep and larger wounds secondarily. Many surgeons elect SI healing in patients with current or previous wound dehiscence, flap necrosis, or infection; in patients who have undergone skin cancer excisions before, or who are elderly, and; if the lesion was sent for permanent section, or when treating high-risk, large, recurrent, or aggressive tumors. CONCLUSION: Broader indications for SI healing of Mohs surgical defects may be appropriate than previously understood. In addition to concave, temporal, periocular, perinasal, and periauricular sites, SI healing may be appropriate for convex sites such as the scalp and anterior lower extremity, deep wounds, and large wounds, as well as wounds with dehiscence, flap necrosis, or infection. Certain patient-specific and lesional factors are also appropriate indications for SI healing.

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.

The Role of Elastic Fibers in Scar Formation and Treatment.

BACKGROUND: Laser therapy is a continuously evolving treatment option for scars, and the underlying therapeutic mechanisms continue to be elucidated. OBJECTIVE: To comprehensively review the literature to summarize the role of elastin in the formation scars, as well as treatment via therapeutic lasers. METHODS: Review of the PubMED/MEDLINE database for available studies pertaining to the role of elastic fibers in scar formation and after laser-based therapy. RESULTS: The loss and disorganization of elastic fiber components plays a role in the development of atrophic, hypertrophic, and keloid scars. While the majority of histologic studies focus on the underlying changes in collagen, neoelastogenesis and reorganization of elastic fibers have also been demonstrated in studies using ablative, nonablative, and fractional laser devices for the treatment of scars. CONCLUSION: Production of novel elastin and normalization of elastic fiber organization occur after a variety of resurfacing procedures to treat scarring. As the treatment modalities to manage scars continue to evolve, further characterization of the role of elastin in the skin and in scar formation is merited.

Lasers, Light, and the Treatment of Acne: A Comprehensive Review of the Literature.

INTRODUCTION: Acne vulgaris is common dermatologic condition with an estimated prevalence of 70 to 87%. Acne has been shown to have a significant impact on patient quality of life and mental health, especially as inflammatory lesions typically occur on cosmetically sensitive areas with the potential for permanent scarring. There have been numerous advances in the treatment of inflammatory acne with light-based and laser devices. OBJECTIVE: To review the current evidence for light-based and laser treatments in the management of inflammatory acne. METHODS: An analysis was conducted of PubMed indexed English language literature regarding management of inflammatory acne using light-based and laser treatments. RESULTS: Evidence for the utilization of laser and light-based therapy for acne was summarized in a comprehensive review. Laser and light-based treatment holds the advantages of improved patient compliance and safety profiles in comparison to pharmacologic therapy. Efficacy of device based treatment varied in comparison to standard topical treatment regimens, often more effective when used in combination therapy. Adverse effects reported were generally self-limited. DISCUSSION: These treatments do and will continue to play an important and enlarging role in the management of acne. Larger scale studies with standardization of treatment protocols are warranted.

J Drugs Dermatol. 2017;16(11):1095-1102.

An Anatomical Approach to Evaluating and Treating Cellulite.

Cellulite is the common rippling or dimpling of skin of the thighs and buttocks of women, formed from a confluence of skin laxity, tethering fibrous septa, and fat herniation. We describe an anatomical approach to evaluating the cellulite patient and selecting the best treatment from among available non-invasive, minimally invasive, and invasive therapies. It is crucial to consider the anatomy of the patient and the morphology of cellulite while choosing a treatment. Diffuse rippling represents increased adiposity and/or increased skin laxity which may stand to benefit from lipolytic and skin tightening modalities. Dimpling represents tethering by fibrous septa which may stand to improve from subcision by minimally invasive devices such as Cell na. Patients with both morphologies may be treated with a combination of treatments or Cellulaze. Careful evaluation of the patient can help identify the best therapeutic strategy. J Drugs Dermatol. 2017;16(1):58-61..

Safety of a picosecond laser with diffractive lens array (DLA) in the treatment of Fitzpatrick skin types IV to VI: A retrospective review.

BACKGROUND: Laser therapy in patients with skin of color is associated with an increased rate of complications. The 755-nm picosecond laser with the diffractive lens array (DLA) has been used for the treatment of scars, striae, and rejuvenation. By delivering high energy to focused areas, the DLA minimizes complications. OBJECTIVE: This study explores the adverse events associated with treatment with the 755-nm picosecond laser with DLA in individuals with Fitzpatrick skin type IV to VI. METHOD: A retrospective chart review of patients treated with the 755-nm picosecond laser with DLA with a standardized spot size of 6 mm, fluence of 0.71 J/cm(2), and pulse width of 750 to 850 picoseconds was performed. Standard clinical photographs were obtained before treatment and at follow-up. Treatment sites were assessed for dyspigmentation, erythema, edema, and herpetic lesions. RESULTS: A total of 56 patients with Fitzpatrick skin type IV to VI, atrophic and hypertrophic scars, and pigmented lesions or striae were included. Ten patients (17.9%) were lost to follow-up. Transient adverse events, most commonly erythema and hyperpigmentation, were reported after therapy; these resolved in all cases. LIMITATIONS: Retrospective design is a limitation. CONCLUSION: The 755-nm picosecond laser with the DLA device may be a safe therapeutic alternative for unwanted scars, pigmented lesions, and striae in patients with skin of color.

Acne scarring: A review of available therapeutic lasers.

BACKGROUND AND OBJECTIVE: The utilization of lasers in dermatology has greatly expanded in recent decades. Acne scarring is a common indication in which lasers play an important therapeutic role. STUDY DESIGN/MATERIALS AND METHODS: Available lasers include traditional ablative lasers, such as carbon dioxide and erbium lasers, traditional non-ablative lasers, such as neodymium, diode, alexandrite, pulsed dye lasers and intense pulse light, as well as both ablative, and non-ablative fractional laser systems. CONCLUSION: We sought to provide a framework for understanding the various types of lasers available to treat acne scars and review the primary literature pertaining to the efficacy, safety, and advantages of each laser discussed.

Treatment of pigmentary disorders in patients with skin of color with a novel 755 nm picosecond, Q-switched ruby, and Q-switched Nd:YAG nanosecond lasers: A retrospective photographic review.

BACKGROUND AND OBJECTIVES: Laser procedures in skin of color (SOC) patients are challenging due to the increased risk of dyspigmentation and scarring. A novel 755 nm alexandrite picosecond laser has demonstrated effectiveness for tattoo removal and treatment of acne scars. No studies to date have evaluated its applications in pigmentary disorders. The purpose of this retrospective study was to evaluate the safety profile and efficacy of the picosecond alexandrite laser compared to the current standard treatment, Q-switched ruby and neodynium (Nd):YAG nanosecond lasers, for pigmentary disorders in SOC patients. STUDY DESIGN/MATERIALS AND METHODS: A retrospective photographic and chart evaluation of seventy 755 nm alexandrite picosecond, ninety-two Q-switched frequency doubled 532 nm and 1,064 nm Nd:YAG nanosecond, and forty-seven Q-switched 694 nm ruby nanosecond laser treatments, in forty-two subjects of Fitzpatrick skin types III-VI was conducted in a single laser specialty center. The picosecond laser was a research prototype device. Treatment efficacy was assessed by two blinded physician evaluators, using a visual analog scale for percentage of pigmentary clearance in standard photographs. Subject assessment of efficacy, satisfaction, and adverse events was performed using a questionnaire survey. RESULTS: The most common pigmentary disorder treated was Nevus of Ota (38.1%), followed by solar lentigines (23.8%). Other pigmentary disorders included post-inflammatory hyperpigmentation, congenital nevus, café au lait macule, dermal melanocytosis, Nevus of Ito, and Becker's nevus. Clinical efficacy of the Q-switched nanosecond lasers and picosecond laser treatments were comparable for lesions treated on the face with a mean visual analog score of 2.57 and 2.44, respectively, corresponding to approximately 50% pigmentary clearance. Subject questionnaires were completed in 58.8% of the picosecond subjects and 52.0% of the Q-switched subjects. Eighty four percent of subjects receiving Q-switched nanosecond laser treatments and 50% of the subjects receiving alexandrite 755 nm picosecond laser treatments felt satisfied to completely satisfied. Side effects observed in subjects treated with the alexandrite 755 nm picosecond laser were similar to those commonly observed and reported with the nanosecond Q-switched technology. All side effects were temporary, resolving within one month, and no long-term complications were noted. All patients who were very satisfied with their picosecond laser treatment for Nevus of Ota noted a delayed improvement only after 3 months. CONCLUSION: The 755 nm alexandrite picosecond, 694 nm ruby, 532 nm, and 1064 nm neodynium:YAG nanosecond lasers appear to be safe and effective modalities for removal of pigmentary disorders in skin of color patients with no long-term complications if used appropriately. This study demonstrates the potential of the 755 nm alexandrite picosecond laser in further clinical applications beyond tattoo removal. While the Q-switched lasers were effective, promising results were also observed using an early version of the novel picosecond laser for the removal of pigmentary lesions in SOC patients. As we continue to improve our understanding of the 755 nm picosecond laser, this device may prove to be a safe and effective alternative to the Q-switched lasers for the treatment of facial pigmented lesions in patients with skin of color.

The Photodynamic Therapy Experience of a High Volume Laser and Dermatologic Surgery Center.

BACKGROUND: Photodynamic therapy (PDT) is an FDA approved treatment for actinic keratoses (AK's) although multiple off-label indi- cations are reported. Despite frequent use for AK's, no clear consensus exists regarding protocols for overall treatment parameters. METHODS: Retrospective chart review of 1,491 subjects who underwent PDT between 2007 and 2011 at a high volume laser surgery center. Demographic information, clinical history, treatment data, and subsequent diagnosis of skin cancers were recorded. An ex- ploratory subgroup analysis was performed for patients treated for AK and/or squamous cell carcinoma (SCC) that developed SCC or remained SCC-free one year after treatment. RESULTS: The most common indications for PDT were actinic keratoses (n=1404, 94.9%) then NMSC (n=45, 3.0%) The most common treatment site was the head and neck (n=1274, 86.1%). Blue light activation (405-420nm) was used more frequently than red light and visible light. (73.8% vs. 22.8% vs. 6.8%). The most commonly used photosensitizer was aminolevulinic acid (ALA) (98.6%, n=1456). Topical application (97.7% n=1437) of photosensitizer was used more frequently than intralesional administration (2.0%, n=29). 580 patients met subgroup analysis criteria. 66 developed SCC at treatment site (11%). Factors associated with developing SCC were older age, SCC history, Fitzpatrick skin-type 1, and sixty-minute or less incubation times (P less than 0.05 for all factors). The SCC subgroup had a unique distribution of treatment sites (P less than.001). No statistically significant differences were observed for gender or wavelength. CONCLUSION: There are differences in protocols based on indication and location of lesion. Blue light is preferable for superFIcial lesions and red light for deeper lesions. Intralesional delivery is used more commonly for NMSC. Extremities require longer incubation times. PDT may be more effective with younger patients and longer than sixty-minute incubation times. PDT chemoprevention is independent of light source used. J Drugs Dermatol. 2016;15(11):1420-1426..

Clearance of yellow tattoo ink with a novel 532-nm picosecond laser.

BACKGROUND AND OBJECTIVES: Although technology and tattoo removal methods continue to evolve, yellow pigment clearance continues to be challenging and usually unsuccessful. We describe a case series of six tattoos containing yellow ink, successfully treated with a frequency-doubled Nd:YAG 532-nm picosecond laser. STUDY DESIGN/MATERIALS AND METHODS: Case series with six subjects participating for the treatment of multicolored tattoos that contain yellow pigment. Treatments performed with a frequency-doubled Nd:YAG 532-nm picosecond laser at 6-8 week intervals. RESULTS: One subject achieved complete clearance of the treated site after one session, and five subjects required 2-4 treatments to achieve over 75% clearance. Minimal downtime was experienced, and no scarring or textural skin changes were observed in any of the treated sites. CONCLUSIONS: This is the first case series that demonstrates effective and consistent reduction of yellow tattoo ink using a frequency doubled Nd:YAG 532-nm laser with a picosecond pulse duration. Treatments were well tolerated and subjects had positive outcomes. This is a small observational case series from an ongoing clinical trial, and studies with a larger sample size and comparative group are needed in the future.

Men and Cosmetics: Social and Psychological Trends of an Emerging Demographic.

Though still accounting for a small fraction of all cosmetic procedures in the United States, men are an emerging and rapidly expanding demographic in the field of aesthetic medicine. In this article we highlight the trends contributing to the rise of male aesthetic procedures in dermatology, touching on social influences, psychological motivations, and treatment outcomes.

Male Aesthetics: A Review of Facial Anatomy and Pertinent Clinical Implications.

Aesthetics continues to be a rapidly growing field within dermatology. In 2014, Americans spent 5 billion dollars on an estimated 9 million minimally invasive cosmetic procedures. Between 1997 and 2014, the number of aesthetic procedures performed on men increased by 273%. The approach to male aesthetics differs from that of females. Men have a squarer face, a more angled and larger jaw, and equally balanced upper and lower facial proportions. Facial muscle mass, subcutaneous tissue, and blood vessel density are also increased in men relative to women. While many of the same cosmetic procedures are performed in males and females, the approach, assessment, and treatment parameters are often different. Improper technique in a male patient can result in feminizing facial features and patient dissatisfaction. With an increasing number of men seeking aesthetic procedures, it behooves dermatologists to familiarize themselves with male facial anatomy and the practice of cosmetic dermatology in this population.

Evaluation of a Low Energy, Low Density, Non-Ablative Fractional 1927 nm Wavelength Laser for Facial Skin Resurfacing.

OBJECTIVE: We investigated the safety, tolerability and efficacy of a low energy low density, non-ablative fractional 1,927-nm laser in the treatment of facial photodamage, melasma, and post inflammatory hyperpigmentation. DESIGN: Prospective non-randomized trial. SETTING: Single center, private practice with a dedicated research department. PARTICIPANTS: Subjects with clinically diagnosed facial photodamage, melasma, or post inflammatory hyperpigmentation. INTERVENTIONS: Subjects received four to six treatments at 14-day intervals (+/- 3 days) with a low energy low density non-ablative fractional 1,927-nm laser (Solta Hayward, CA) with an energy level of 5 mJ, and density coverage of either 5%, 7.5%, or 10%, with a total of up to 8 passes. MAIN OUTCOME AND MEASURES: Blinded assessment of clinical photos for overall improvement at one and three months post final treatment. Investigator improvement scores, and subject pain and satisfaction scores for overall improvement were recorded as well. RESULTS: We enrolled 23 subjects, average age 45.0 years (range, 25-64 years), 22 with Fitzpatrick Skin Types I-IV and 1 with Type VI, with facial photodamage, melasma, or post inflammatory hyperpigmentation. Approximately 55% of subjects reported marked to very significant improvement at one and three months post final treatment. Blinded assessment of photography of 20 subjects revealed an average of moderate improvement at one-month follow up and mild to moderate improvement at three months. Average subject pain score was 3.4/10 during treatment. CONCLUSIONS AND RELEVANCE: Favorable outcomes were demonstrated using the low energy low density, non-ablative fractional 1,927-nm laser in facial resurfacing for photodamage, melasma, and post inflammatory hyperpigmentation. Results were maintained at the 3-month follow up, as demonstrated by investigator and subject assessments, as well as blinded evaluations by three independent dermatologists utilizing photographs obtained from a standardized facial imaging device.

Laser therapy in the treatment of connective tissue diseases: a review.

BACKGROUND: Connective tissue diseases (CTD), including lupus erythematosus (LE), scleroderma, sarcoidosis, and dermatomyositis, present with clinically unique cutaneous manifestations often resistant to conventional therapy. The use of lasers in the treatment of various dermatologic conditions continues to expand, presenting an opportunity for incorporation of another mechanism of action in the treatment of CTD. OBJECTIVES: To review the use of laser therapy in the treatment of LE, scleroderma, sarcoidosis, and dermatomyositis. MATERIALS AND METHODS: A MEDLINE search was conducted to find articles detailing treatment of CTD with laser therapy. RESULTS: Thirty-nine published articles were identified. The outcomes and results of case reports were reviewed for each CTD when possible. CONCLUSIONS: Laser therapy offers novel and often effective treatment for recalcitrant cutaneous conditions in LE, scleroderma, sarcoidosis, and dermatomyositis. Review of the literature revealed a limited number of reports, many describing outdated technologies and techniques. It is therefore difficult to draw substantial conclusions regarding safety and the known association with photosensitivity. More-recent reports suggest that, with continued evolution of technology and understanding of CTD, lasers will have an expanding role in the treatment of cutaneous manifestations of CTD.

High-intensity focused ultrasound for the reduction of subcutaneous adipose tissue using multiple treatment techniques.

BACKGROUND: High-intensity focused ultrasound (HIFU) is a noninvasive alternative to traditional invasive body sculpting procedures. OBJECTIVE: To assess the effectiveness and tolerability of HIFU treatment using high and low fluence settings with 2 treatment techniques, grid repeat (GR) and site repeat (SR). MATERIALS AND METHODS: Two multicenter studies were conducted. Subjects underwent 1 HIFU treatment with 1 of 5 treatment protocols (total fluence, 150-180 J/cm). Primary end point was change from baseline in waist circumference (CBWC) at 12 weeks. Secondary end points included CBWC at 4 and 8 weeks and investigator- and subject-assessed clinical improvement. Adverse events were monitored throughout the study. RESULTS: In the intent-to-treat (ITT) population, all subjects had a statistically significant mean circumferential reduction of -2.3 ± 2.9 cm (p < .0001) from baseline at 12 weeks, with no significant differences among the 5 treatment groups (ITT: p = .153). Analysis of secondary end points in the ITT population demonstrated a significant circumferential reduction starting as early as 4 weeks in all subjects (-1.1 ± 1.9 cm, p < .0001). Most subjects in all treatment groups showed improvements at 12 weeks as rated by the investigators and subjects. CONCLUSION: High-intensity focused ultrasound treatment using either a low or high fluence setting in a GR or SR method is effective for circumferential waist reduction, resulting in statistically significant CBWC in all treatment groups.