High-Intensity, High-Frequency, Parallel Ultrasound Beams for Cellulite of the Buttocks and Thighs.

BACKGROUND: Ultrasound energy can successfully treat fine lines and wrinkles, as well as lift the eyebrow and submentum. Ultrasound waves of high intensity induce thermal injury in the dermis with subsequent tissue remodeling. OBJECTIVE: To examine the utility of a novel ultrasound device that utilizes high-intensity, high-frequency, parallel ultrasound beams to improve the clinical appearance of cellulite on the thighs and buttocks. MATERIALS AND METHODS: A prospective, multicenter, clinical study investigated this novel ultrasound device using 2 treatments. RESULTS: Sixty-five subjects completed both treatments. The mean age was 46 years, and 100% were women. Fitzpatrick skin types I to VI were represented. Assessments compared 3-month follow-up with baseline. Two blinded reviewers agreed in identifying pretreatment and post-treatment photographs for 89.2%. For Cellulite Severity Scale rating, there was significant improvement of 1.61 units (p < .001). For cellulite Global Aesthetic Improvement Scale (GAIS), 89.2% had improvement, with a mean of 0.87 units (p < .001). For Laxity Scale rating, there was significant improvement of 0.70 units (p < .001). For skin laxity GAIS, 89.2% had improvement, with a mean of 0.76 units (p < .001). No device-related adverse events occurred. CONCLUSION: A novel ultrasound device that utilizes high-intensity, high-frequency, parallel ultrasound beams can safely and effectively improve the clinical appearance of cellulite on the thighs and buttocks.

Real-time, in vivo skin cancer triage by laser-induced plasma spectroscopy combined with a deep learning-based diagnostic algorithm.

BACKGROUND: Although various skin cancer detection devices have been proposed, most of them are not used owing to their insufficient diagnostic accuracies. Laser-induced plasma spectroscopy (LIPS) can noninvasively extract biochemical information of skin lesions using an ultrashort pulsed laser. OBJECTIVE: To investigate the diagnostic accuracy and safety of real-time noninvasive in vivo skin cancer diagnostics utilizing nondiscrete molecular LIPS combined with a deep neural network (DNN)-based diagnostic algorithm. METHODS: In vivo LIPS spectra were acquired from 296 skin cancers (186 basal cell carcinomas, 96 squamous cell carcinomas, and 14 melanomas) and 316 benign lesions in a multisite clinical study. The diagnostic performance was validated using 10-fold cross-validations. RESULTS: The sensitivity and specificity for differentiating skin cancers from benign lesions using LIPS and the DNN-based algorithm were 94.6% (95% CI: 92.0%-97.2%) and 88.9% (95% CI: 85.5%-92.4%), respectively. No adverse events, including macroscopic or microscopic visible marks or pigmentation due to laser irradiation, were observed. LIMITATIONS: The diagnostic performance was evaluated using a limited data set. More extensive clinical studies are needed to validate these results. CONCLUSIONS: This LIPS system with a DNN-based diagnostic algorithm is a promising tool to distinguish skin cancers from benign lesions with high diagnostic accuracy in real clinical settings.

Improved Patient Satisfaction With Skin After Treatment of Cheek Skin Roughness and Fine Lines With VYC-12L: Participant-Reported Outcomes From a Prospective, Randomized Study.

BACKGROUND: VYC-12L is a hyaluronic acid filler to improve skin quality. A prospective study showed safety and effectiveness of VYC-12L for improving cheek skin smoothness and fine lines. OBJECTIVES: To report participant-reported outcomes, subgroup analyses, and physician experience from the prospective study. METHODS: Adults with moderate to severe Allergan Cheek Skin Smoothness (ACSS) scale scores were randomized 2:1 to VYC-12L or control (no treatment with optional treatment). Participant assessments included FACE-Q Satisfaction With Skin, FACE-Q Appraisal of Lines, natural look and feel, the Global Aesthetic Improvement Scale (GAIS), and safety. Subgroup analyses examined ACSS responder rate (≥1-grade improvement from baseline to 1 month). RESULTS: FACE-Q Satisfaction With Skin overall mean scores improved from baseline to 1 month posttreatment by 32.0 and 1.4 in the VYC-12L and control groups, respectively. FACE-Q Appraisal of Lines overall mean scores improved from baseline to 1 month posttreatment by 23.3 and 0.4 in VYC-12L and control, respectively. Treated participants had high median scores (≥9.0) of natural look and feel of their cheek skin. GAIS responder rate was high at Month 1 (85.5%; 95% CI, 79.3%-91.7%) and through Month 6 (83.1%; 95% CI, 76.5%-89.7%). Mean participant-rated pain scores were low (<3). The most common injection site reactions were redness, swelling, and lumps/bumps; most resolved within 3 days. Subgroup analyses showed significant differences in ACSS responder rate between VYC-12L and control groups 1 month posttreatment. Physician injectors reported that VYC-12L was easily injected at the superficial skin and integrated quickly. CONCLUSIONS: VYC-12L treatment produced significant improvements in satisfaction with skin and cheek skin smoothness, as measured by participant-reported outcome measures.

Safety, Efficacy, and Tolerability of Simultaneous Bilateral Cryolipolysis Using a Rapid Cycling Contoured Cup Applicator for Noninvasive Fat Reduction in the Enlarged Male Breast: A Pilot Study.

BACKGROUND: A previous study using a parallel cooling plate cryolipolysis applicator demonstrated the efficacy of cryolipolysis for pseudogynecomastia. Although the procedure was safe and effective, treatment times were prolonged and anesthetic was needed to reduce treatment discomfort. OBJECTIVE: To evaluate the safety, efficacy, and tolerability of a short cycle, reduced vacuum contoured cup cryolipolysis applicator for the treatment of pseudogynecomastia. MATERIALS AND METHODS: Twelve male subjects received simultaneous bilateral treatment consisting of a 35-minute cryolipolysis cycle, followed by a short manual massage, and a second 35-minute cycle with 50% treatment area overlap in a single treatment visit. At the 6-week follow-up, a second treatment was performed with up to 2 overlapping cycles per side. Efficacy was assessed after the second treatment using transcutaneous ultrasound, standardized clinical photography, and subject surveys. RESULTS: Ultrasound analysis showed a mean fat layer reduction of 5.1 ± 2.3 mm (p < .001). Blinded, independent reviewers correctly identified 97% of baseline/treatment photography results. Surveys revealed 100% subject satisfaction with 91% reporting visible fat reduction and 100% stating they would recommend treatment. Transient side effects included mild intratreatment discomfort, paresthesia, and tenderness. CONCLUSION: A rapid cycling, reduced vacuum cryolipolysis applicator provides rapid, safe, effective, and tolerable treatment of pseudogynecomastia.

A Randomized Controlled Pilot Study: Combined 595-nm Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride Topical Cream Superior to Oxymetazoline Hydrochloride Cream for Erythematotelangiectatic Rosacea.

BACKGROUND AND OBJECTIVES: We evaluated if oxymetazoline therapy combined with 595-nm pulsed dye laser (PDL) will be more beneficial than topical oxymetazoline alone for the improvement of erythematotelangiectatic rosacea. STUDY DESIGN/MATERIALS AND METHODS: This was a randomized, controlled, prospective clinical trial approved by an independent Institutional Review Board, which enrolled 34 patients with moderate to severe clinical erythema (CEA) into a two-arm study of PDL with concomitant oxymetazoline cream (Arm 1) and oxymetazoline cream alone (Arm 2). Patients in Arm 1 were treated with 3 monthly laser sessions, which were started after 1 month of topical oxymetazoline cream. Thirty subjects continued with the study, and 25 subjects (Arm 1: 14, Arm 2: 11) completed the 6-month follow-up. With photographic comparison to baseline images, efficacy endpoints were based on clinical on-site grading by both the investigator and the patient, using the grading tools for CEA, Global Aesthetic Improvement (GAI) assessment, vessel size improvement, and subject self-assessment. These scales were assessed at baseline and/or at each clinical follow-up at 1, 2, 3, and 6 months. Subject satisfaction as well as post-treatment immediate response and treatment-associated pain scores were also evaluated. RESULTS: Statistically significant improvement in CEA was seen in both arms at the 1-, 2-, and 3-month post-baseline visits (P < 0.01). Only Arm 1 presented statistically significant improvement in CEA (P < 0.001) at 6 months post baseline with a mean score of 1.6 (almost clear-mild) compared with 3.2 at baseline. Arm 1 showed significantly greater mean vessel size improvement at 3 months (P < 0.01) and 6 months (P < 0.05) post baseline compared to Arm 2. Significantly greater improvement (P < 0.05) in the investigator GAI score was reported at the 2- and 6-month follow-ups compared with Arm 2. Subject GAI scores showed statistically significant greater improvement in Arm 1 compared with Arm 2 at both the 3- and 6-month follow-ups (P < 0.01). There were no complications or long-term effects associated with PDL or topical oxymetazoline treatments. CONCLUSION: The prospective trial verifies a safe, enhanced clinical outcome with the combination of PDL therapy and topical oxymetazoline for the treatment of erythematotelangiectatic rosacea patients. Lasers Surg. Med. © 2021 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC.

Safety and Efficacy of Nano-Pulse Stimulation Treatment of Non-Genital, Cutaneous Warts (Verrucae).

BACKGROUND AND OBJECTIVES: This study describes the effects of nano-pulse stimulation (NPS) technology on the common verruca with the objectives of demonstrating efficacy and safety. NPS technology applies nanosecond pulses of non-thermal electrical energy to induce highly localized regulated cell death in the cellular structures of the targeted zone with negligible effects on surrounding non-cellular structures. Previous clinical studies applying NPS to common, benign skin lesions have demonstrated safety and efficacy in clearing seborrheic keratoses and sebaceous hyperplasia. STUDY DESIGN/MATERIALS AND METHODS: Sixty-two subjects were enrolled at a total of five sites. One hundred and ninety-five study verrucae up to 10 mm wide were treated with NPS delivered by a console-based handheld applicator (CellFX® System; Pulse Biosciences) and follow-ups occurred every 30 days with the option to retreat at 30, 60, and 90 days. There were 62 untreated controls and 46% of the treated verrucae were recalcitrant. RESULTS: Overall, 75.3% (70/93) of the common verrucae, 72.7% (8/11) of the flat verrucae, and 43.8% (14/32) of the plantar verrucae treated with NPS were completely clear by 60 days following the last treatment and did not recur within the 120-day observation period. The majority (54%) of verrucae cleared with a single NPS procedure. The most common treatment site reactions were erythema (50.5%) and eschar formation (23.4%) on Day 30 and on Day 120 mild erythema was present in 14% of the cases and hyperpigmentation in 18.5%. No serious adverse events were reported. A particle counter was used during 11 NPS procedures on verrucae and no significant plume generation was detected during these procedures. CONCLUSIONS: NPS is a safe and effective procedure for removing non-genital, cutaneous verrucae. Lasers Surg. Med. © 2021 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC.

AbobotulinumtoxinA for the Treatment of Moderate-to-Severe Glabellar Lines: A Randomized, Dose-Escalating, Double-Blind Study.

OBJECTIVE: To evaluate the efficacy and safety of AbobotulinumtoxinA (ABO) dose escalation in the correction of moderate-to-severe glabellar lines. DESIGN: Phase 2, 36-week, multicenter, randomized, dose-ranging, double-blind, placebo-controlled study. METHODS: Adults with moderate-to-severe glabellar lines received a single ABO treatment, dosed at 50, 75, 100, or 125 U, or placebo. Primary endpoint was week 4 composite ≥2-grade responder rate among those achieving a severity score of 0 (none) or 1 (mild) at maximum frown, evaluated using concurrent investigator and subject assessments. Secondary endpoints included ≥1-grade severity improvement, duration of effect, and reporting of treatment-emergent adverse events (TEAEs). RESULTS: Overall, 399 subjects were included (88.2% were female). Week 4 composite ≥2-grade ABO responder rate was 80.0% (50 U), 88.8% (75 U), 90.0% (100 U) and 95.1% (125 U), versus 2.6% with placebo (P<0.001). Responder rate (≥1-grade) ranged between 53% (50 U) and 69% (125 U) at week 24 and between 18% (50 U) and 31% (125 U) at week 36. Median time (weeks) to return to baseline severity/worse, among those scoring 0 (none) or 1 (mild), was 32.3 (50 U), 34.3 (75 U), 36.0 (100 U) and 36.6 (125 U), versus 23.7 (placebo). ABO-related TEAEs were reported in 4% of subjects (80% were mild). No seroconversion to ABO neutralizing antibodies was seen. CONCLUSION: A single ABO treatment provided rapid and effective improvements in glabellar line severity at all doses. Higher doses tended to demonstrate elevated response rates and longer duration of effect. All ABO doses were well-tolerated with low TEAE incidence. J Drugs Dermatol. 2021;20(9):980-987. doi:10.36849/JDD.6263.

ATX-101 (Deoxycholic Acid Injection) Leads to Clinically Meaningful Improvement in Submental Fat: Final Data From CONTOUR.

BACKGROUND: Submental fat (SMF) can negatively affect perceptions of health and attractiveness. The Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR) was designed to understand SMF treatment in clinical practice. OBJECTIVE: To report efficacy, treatment characteristics, and safety associated with real-world use of ATX-101 (deoxycholic acid injection). METHODS: CONTOUR enrolled adults considering treatment for SMF reduction. ATX-101-treated patients who completed the end-of-treatment questionnaire were divided into those who ended treatment because they met their treatment goals (n = 197) and those who did not (n = 196). RESULTS: Patients who met their goals (a more defined jawline, looking younger, and looking thinner) were more likely to have less SMF at baseline and to receive ≥2 ATX-101 treatments. More patients who met their goals achieved clinically meaningful reduction in SMF and reported increased satisfaction with their appearance (90% vs 57%). Moderate and severe patients' ATX-101 volume was similar for both those who met goals and those who did not, but extreme patients who met their goals required 10 mL more than those patients who did not. CONCLUSION: Careful patient selection, adequate volume administration, and an appropriate number of treatments (dependent on baseline SMF severity) contribute to successful outcomes with ATX-101.

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.

Fractional high intensity focused radiofrequency in the treatment of mild to Moderate laxity of the lower face and neck: A pilot study.

BACKGROUND AND AIMS: The aging process is commonly associated with skin laxity in the lower face and neck. Conventional surgery can correct this at least to some extent, but is invasive. Fractional high-intensity focused radiofrequency delivered to the dermis with insulated microneedles has recently attracted attention in facial rejuvenation. The present pilot study was designed to assess the efficacy of HiFR for skin laxity of the lower face and neck. METHODS: Thirty-three patients (7 males, 26 females, age range 37-74 years) with mild to moderate skin laxity of the lower face/neck participated in the study. Three treatments were given at monthly intervals with protocols developed by the authors, three passes per session, at decreasing dermal depths for each pass. Histologic assessment of skin immediately after treatment was performed to identify the site and area of damage in the dermis. Clinical digital photography was taken at baseline and at 6 months after the final treatment session, based on which standardized computer measurement of improvement in the gnathion and cervicomental angles was the primary objective evaluation. A global assessment of improvement was graded by blinded assessors based on the photography. A telephone survey of patient satisfaction was performed at 12 months post-treatment. RESULTS: A significant post-treatment decrease in the cervicomental and gnathion angles was seen of 28.5° and 16.6°, respectively (P < 0.0001 for both). Histology immediately post-treatment showed a clear demarcated and roughly oval area of coagulation associated with the tip of the needle, confined to the dermis and not involving the epidermis. In the global assessment 81.8% of the patients achieved moderate or higher results, and 87% of patients were very satisfied or better. Downtime was minimal, lasting 3-4 days, and no persistent adverse events were recorded. CONCLUSIONS: Fractional HiFR proved safe and effective in the treatment of neck laxity in a large age range of patients, including the elderly. Lasers Surg. Med. 48:461-470, 2016. © 2016 Wiley Periodicals, Inc.

Photodynamic Therapy: A Clinical Consensus Guide.

BACKGROUND: The American Society of Dermatologic Surgery (ASDS) periodically develops consensus documents for its members concerning various aspects of dermatologic surgery. Advances in photodynamic therapy (PDT) have been many and PDT use has been established in a variety of skin conditions. OBJECTIVE: The ASDS board of directors proposed a committee of experts in the field to develop consensus documents on different treatments. An expert panel reviewed the literature on PDT and discussed the findings. The consensus was reached with evidence-based recommendations on different clinical applications for PDT. PATIENTS AND METHODS: This consensus document includes discussions regarding PDT, including different photosensitizers and various light source activators, historical perspective, mechanism of action, various therapeutic indications and expected outcomes, pre- and post-care, and management of adverse outcomes. RESULTS: Photodynamic therapy is highly effective for pre-cancerous lesions, superficial nonmelanoma skin cancers, inflammatory acne vulgaris and other conditions. New protocols including laser mediated PDT significantly improve results for several indications. CONCLUSION: The ASDS consensus document on PDT will be helpful for educating members on safe and effective PDT for a variety of indications.

A Split-Face Assessment of the Synergistic Potential of Sequential Q-Switched Nd:YAG Laser and 1565 nm Fractional Nonablative Laser Treatment for Facial Rejuvenation in Fitzpatrick Skin Type II-V Patients.

Recent appreciation of the multifactorial pathophysiology of skin aging has led to increased use of parallel treatment regimens. This prospective, split-face, randomized study assessed the safety and efficacy of same-day sequential Q-switched Nd:YAG laser and 1565 nm non-ablative fractional laser (SST) facial rejuvenation treatment in comparison to fractional non-ablative laser (NAFL) treatment only. Seventeen patients underwent three treatment sessions, conducted at 4-6-week intervals, in which SST treatment was delivered on a randomly selected side of the face followed by NAFL treatment on the contralateral side immediately thereafter. Immediate skin responses were assessed within 30 minutes of treatment, while wrinkle/elastosis scores, and skin tone and texture were evaluated 1, 3, and 6 months following the final treatment session. While SST and NAFL proved equally safe, SST was associated with signi cantly lower pain scores in all three treatment sessions. Both treatment regimens yielded signi cant improvements in wrinkle/elastosis scores, which were maintained throughout the 6 months of follow up. Physician-evaluated skin tone and patient ratings of skin texture and overall improvement of the SST-treated side were consistently higher than the contralateral NAFL-treated side. Histological analysis suggested a broader effect, alongside sparing of the outermost epidermal layer with the SST versus NAFL treatment. Although the SST regimen failed to demonstrate statistically signi cant clinical superiority over the NAFL regimen, the significantly lower pain levels, consistently higher physician and patient ratings following SST may justify its regular use as a skin rejuvenation technique. J Drugs Dermatol. 2016;15(11):1335-1342..

Low-fluence 585 nm Q-switched Nd:YAG laser: a novel laser treatment for post-acne erythema.

BACKGROUND: Persistent post-acne erythema is one of the most common aesthetic sequelae to arise after active acne resolves. The treatment remains challenging due to lack of effective laser modalities. OBJECTIVES: To evaluate the safety and efficacy of a low-fluence 585 nm Q-switched Nd:YAG laser for the treatment of post-acne erythema. MATERIALS & METHODS: Twenty-five patients with post-acne erythema were treated with a low-fluence Q-switched Nd:YAG laser using the 585 nm Gold Toning™ handpiece (5 mm spot size, 5-10 ns, 0.30-0.55 J/cm(2) , 2-4 passes) for three sessions at 2-week intervals. Erythema lesion (macules) count, inflammatory acne (papules, pustules) count, erythema index, degree of post-acne erythema and overall improvement in post-acne erythema and acne scar were assessed at baseline, every 2 weeks and 6 weeks after the last treatment. Subjective degrees of satisfaction were also evaluated. Adverse events were recorded and pain was scored using a visual analog scale (VAS). RESULTS: At 6 weeks after 3 sessions of laser treatment, all patients demonstrated clinical improvement. Erythema lesion counts decreased by 20.1% (versus baseline) after the first treatment (P = 0.004), by 32.7% after the second treatment, by 46.5% at 2 weeks after the third treatment and by 58.7% at the 6-week follow-up (all P < 0.001). Significant improvements were also noted in erythema indices (22.29 ± 2.4 to 17.51 ± 1.8) and mean post-acne erythema scores after the first treatment (both P < 0.001). The mean scores of independent physician assessments were 4.04 ± 0.9 in term of the improvement of post-acne erythema and 3.44 ± 0.9 in the improvement of scarring. In addition, we could observe a significant decrease in inflammatory acne lesion counts after two laser treatments with a decrease in mean lesion counts by 67% at the 6-week follow-up. Treatment was well-tolerated and adverse effects were limited to transient erythema and edema at treatment sites. CONCLUSIONS: Low-fluence 585 nm Q-switched Nd:YAG laser treatment is safe and effective for the treatment of post-acne erythema with minimal discomfort and quantifiable improvement in the appearance of early acne scarring and inflammatory acne.

Fractional 1,550 nm Ytterbium/Erbium fiber laser in the treatment of lichen amyloidosis: clinical and histological study.

BACKGROUND AND OBJECTIVE: Lichen amyloidosis is characterized by amyloid deposition in the papillary dermis, presenting clinically with intensely pruritic hyperkeratotic papules. Various treatment modalities have been used but the results are generally unsatisfactory. Several studies show that non-ablative fractional lasers can be used to treat depositional diseases due to their capability of inducing transepidermal elimination of the dermal content. To investigate the efficacy and safety of a non-ablative fractional 1,550 nm Yttrium/Erbium fiber laser for the treatment of lichen amyloidosis. MATERIALS AND METHODS: Ten subjects with a clinical and histological diagnosis of lichen amyloidosis were treated with fractional non-ablative laser using a 7-cm tip, with the parameter of 30 mJ/cm2 and 1,000 microscopic treatment zones (MTZ)/cm2 for three sessions at 4-week intervals. Clinical improvement (in terms of global improvement score, brownish/hyperpigmentation, thickness, and number of papules) was evaluated using a quartile grading scale at baseline, and 4, 12, and 24 weeks after the last treatment. Itch score and subjective satisfaction rates were also assessed. Adverse events were recorded, and pain was scored using a visual analog scale (VAS). Histologic changes were observed using standard staining with hematoxylin and eosin, as well as special stains of alkaline congo red and crystal violet at baseline and 4 weeks after treatment. RESULTS: At 4 and 24 weeks after treatment, the lichen amyloid lesions had statistically significantly improved in all aspects compared to baseline (P = 0.01 and P = 0.016, respectively; Wilcoxon signed-rank test). However, partial recurrence was reported in 2 out of 10 subjects. All subjects rated itching symptom significantly improved after only the first treatment (P < 0.05). Minimal side effects were recorded, including a burning sensation, transient erythema, and edema. Histological evaluation demonstrated decreased epidermal thickness, and degeneration and shrinkage of amyloid material deposition in the papillary dermis. There was no amyloid material deposition noted in two out of eight histopathology studies. CONCLUSIONS: The non-ablative fractional 1,550 nm Ytterbium/Erbium fiber laser is safe and effective for the treatment of lichen amyloidosis. However, larger controlled studies are required to further establish the efficacy of this treatment.

Cryolipolysis for Targeted Fat Reduction and Improved Appearance of the Enlarged Male Breast.

BACKGROUND: Pseudogynecomastia refers to benign male breast enlargement due to excess subareolar fat. Standard treatment is surgical excision under general anesthesia, liposuction, or a combination of both. OBJECTIVE: The safety and efficacy of cryolipolysis was investigated for nonsurgical treatment of pseudogynecomastia. METHODS AND MATERIALS: Enrollment consisted of 21 males with pseudogynecomastia. Subjects received a first treatment consisting of a 60-minute cryolipolysis cycle, followed by a two-minute massage, and a second 60-minute cycle with 50% treatment area overlap. At 60 days of follow-up, subjects received a second 60-minute treatment. Safety was evaluated by monitoring side effects and adverse events. Efficacy was assessed by ultrasound, clinical photographs, and subject surveys. RESULTS: Surveys revealed that 95% of subjects reported improved visual appearance and 89% reported reduced embarrassment associated with pseudogynecomastia. Ultrasound showed mean fat layer reduction of 1.6 ± 1.2 mm. Blinded reviewers correctly identified 82% of baseline photographs. Side effects included mild discomfort during treatment and transient paresthesia and tenderness. One case of paradoxical hyperplasia (PH) occurred but likelihood of PH in the male breast is not believed to be greater than in any other treatment area. CONCLUSION: This study demonstrated feasibility of cryolipolysis for safe, effective, and well-tolerated nonsurgical treatment of pseudogynecomastia.