A Novel Approach to Shaping the Lateral Abdomen: Simultaneous Application of High-Intensity Focused Electromagnetic (HIFEM) Therapy and Synchronized Radiofrequency at the Flanks: A Multicenter MRI Study.

BACKGROUND: An accumulation of adipose tissue on the lateral abdomen (flanks) coupled with muscle deconditioning negatively affects core stability, muscular balance, and the intrinsic strength essential for maintaining optimal body mechanics and posture. This lateral fat accumulation and diminution of muscle result in an unfavorable abdominal profile and present challenges in finding appropriately fitting attire. OBJECTIVES: The aim of this study was to explore the effectiveness and safety of the simultaneous application of high-intensity focused electromagnetic (HIFEM) therapy and synchronized radiofrequency for sculpting the lateral abdomen. METHODS: All patients were scheduled to undergo four 30-minute treatments at approximately weekly intervals and then subsequent follow-up visits at 1 month and 3 months after the last treatment. The primary evaluation assessed changes in the oblique muscles, adipose tissue thickness, and cross-sectional area (CSA) by MRI performed at baseline and follow-ups. The secondary outcomes included digital photographs of the treated areas, a Subject Satisfaction Questionnaire, and a Therapy Comfort Questionnaire. Adverse events and side effects were monitored throughout the study duration. RESULTS: The muscle tissue showed a substantial increase in thickness (+27.2%) and CSA (+29.0%). The adipose tissue measurements showed a decrease of -30.5% in CSA and -28.8% in thickness. As secondary outcomes, 81.8% of patients reported feeling more toned, and 84.9% of patients found the treatment comfortable and reported less than mild pain. CONCLUSIONS: Based on the evaluation, the study suggests that the simultaneous application of HIFEM and synchronized radiofrequency is safe and effective for reducing adipose tissue and strengthening muscle in the area of the lateral abdomen.

Clinical evaluation of the safety and efficacy of a 1064 nm diode laser, and vacuum assisted pulsed electromagnetic fields and multipolar radio frequency for noninvasive fat reduction of the abdomen and flanks.

BACKGROUND: Noninvasive cosmetic body contouring techniques are growing rapidly, and noninvasive lipolysis has been shown to have low pain, little downtime and produce consistent long-term results. The objective of this study was to evaluate the safety and efficacy of a 1064 nm diode laser combined with vacuum assisted PEMF and RF energies for noninvasive fat reduction of the abdomen and flanks. METHODS: Subjects received a series of three treatments 8 weeks apart, each consisting of a diode laser session, followed by vacuum assisted PEMF and RF. Before and after photographs were graded for overall fat reduction by three blinded evaluators. Ultrasound was used to measure changes in the thickness of adipose tissue. Subject satisfaction was assessed using the 5-Point Likert Subject Satisfaction Scale and a subject questionnaire at 16 and 24-week follow-up visits. Throughout each treatment, the subjects were given the Wong-Baker Faces Pain Rating Scale (WBFS) to assess discomfort and pain of the treatment. RESULTS: Thirty-nine subjects (average age 48.6 years) from four clinical sites were enrolled. Evaluators identified the correct before and after images 73.1% of the time and images were graded an average score of 1.12 (SE 0.1) correlating to more than a "slight change." Adipose tissue was reduced by 31.9% based on ultrasound measurements (p < 0.001). Subject satisfaction was high with an average satisfaction score of 7.8 ("satisfied") out of 10. The overall pain over time on average was rated "hurts little bit." Ninety percent of subjects reported either a mild, moderate, or significant improvement in their fat reduction and skin surface appearance. Almost 77% (76.7%) of subjects reported that they would recommend the treatment to a friend. There were six reports of adverse events related to the device during the study that were all transient and resolved rapidly. CONCLUSION: A significant reduction of subcutaneous adipose tissue was measured after treatment with a combination of diode laser and vacuum assisted PEMF and RF. Treatment pain was low and tolerable, and subjects had high levels of satisfaction with the results.

1,550 nm Erbium-Doped and 1,927 nm Thulium Nonablative Fractional Laser System: Best Practices and Treatment Setting Recommendations.

BACKGROUND: The Fraxel Dual laser system (Solta Medical, Inc., Bothell, WA) contains a 1,550 and 1,927 nm wavelength single handpiece with different indications for each wavelength. OBJECTIVE: To discuss treatment setting recommendations and best practices for select on-label and investigational applications of the 1,550 and 1,927 nm dual laser system. MATERIALS AND METHODS: Eight board-certified dermatologists with 10 or more years of experience with the 1,550 and 1,927 nm laser system completed an online survey about their clinical experience with the system and then participated in a roundtable to share clinical perspectives and best practices for using the laser system. RESULTS: For all Fitzpatrick skin types, treatment recommendations were described for selected approved indications for the 1,550 and 1,927 nm laser system, including both lasers in combination. Treatment recommendations were also reached for investigational applications with the 1,550 nm laser and 1,927 nm laser. Best practices for using the lasers during the treatment session to achieve optimal outcomes and decrease the post-treatment recovery time were compiled. CONCLUSION: The 1,550 and 1,927 nm dual laser system is effective for a wide range of aesthetic and therapeutic applications, on and off the face and across all Fitzpatrick skin types.

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 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.

An Observational Study of the Safety and Efficacy of Tissue Stabilized-Guided Subcision.

BACKGROUND: Cellulite is a common female cosmetic concern for which there are few treatment options with long-term effectiveness data. The aim of this multisite prospective registry study was to collect observational data on the real-life clinical use of a tissue stabilized-guided subcision (TS-GS) system for long-term improvement of cellulite appearance. METHODS: Fifty-three subjects were enrolled and received a single treatment using the TS-GS system. Physicians treated the subjects according to their standard of care. Global Aesthetic Improvement Scale (GAIS) was completed by the patient and clinician assessing overall aesthetic improvement after 180 days. Treatment parameters, pain scores, quality of life data, and expected treatment effects and adverse events were also recorded throughout the study. RESULTS: The patient and physician GAIS scores at Day 180 revealed an overall improvement in 91% and 96% of patients, respectively. Quality of life and self-confidence scores also improved through 180 days. No serious adverse events were reported. Expected treatment effects were similar to those reported in the pivotal trial supporting FDA clearance. CONCLUSION: This study demonstrated significant improvement in the appearance of cellulite after a single treatment session in patients with moderate-to-severe cellulite. These results are consistent with the previously published the pivotal study data.

Non-Surgical Fat Reduction and Topical Modulation of Adipose Tissue Physiology

Non-surgical fat reduction procedures have gained in popularity over the past few years and remain in great demand. The process results in accumulation of breakdown products, lipid droplets, that are slowly absorbed over a period of months. This paper outlines the physiological process whereby lipid droplets are absorbed through a process of autophagy (lipophagy) involving a repackaging of these droplets to smaller sizes so that macrophages can then cope with digestion of these very large particles. Furthermore, a fat compartment is described within the dermis surrounding the tail of the hair follicle, which is attracting much attention due to its unique phenotype, function, and connection to the deeper subcutaneous fat compartment. This provides an entry route for direct signaling to the subcutaneous fat. Related to these novel concepts, peptides can be designed in liposomal delivery systems to target lipid droplet breakdown via the hair follicle entry route. This concept is elucidated in this paper. J Drugs Dermatol. 2019;18(4):375-380.

Prototype CoolCup cryolipolysis applicator with over 40% reduced treatment time demonstrates equivalent safety and efficacy with greater patient preference.

BACKGROUND AND OBJECTIVES: Cryolipolysis is a safe, effective non-surgical procedure to reduce fat. For most cryolipolysis treatments, tissue is pulled between parallel cooling plates with a treatment duration of 60 minutes. A novel contoured cup, medium-sized applicator was developed to increase tissue contact with reduced skin tension and reduced treatment time. This prototype contoured cup was investigated with a standard cryolipolysis applicator to evaluate safety, efficacy, and patient preference. STUDY DESIGN/MATERIAL AND METHODS: A prototype CoolCup medium-sized vacuum applicator (CoolSculpting System, ZELTIQ Aesthetics) was used to treat n = 19 subjects in the flanks. Randomly assigned, one flank received standard treatment with the CoolCore applicator (-10°C for 60 minutes). The contralateral flank received treatment from the CoolCup (-11°C for 35 minutes). The clinical study primary efficacy endpoint was 70% correct identification of baseline photographs by independent physician review. Incidence of adverse device effects was monitored. Fat layer reduction was measured by ultrasound and subject surveys were administered 12 weeks post-treatment. RESULTS: Equivalent efficacy was demonstrated between the CoolCore standard treatment and the prototype CoolCup. Independent review from three blinded physicians found 81% correct identification of baseline photographs for the standard treatment and 79% for the CoolCup. Ultrasound measurements indicated mean fat layer reduction of 4.38 mm for the standard treatment and 4.40 mm for the CoolCup; no statistically significant difference was found when comparing treatment efficacy of the two applicators (P = 0.96). Patient questionnaires revealed 85% preferred CoolCup because of shorter treatment duration and greater comfort. Procedural assessments revealed 45% lower pain scores for CoolCup. Immediate post-treatment clinical assessments revealed 82% less bruising. Typical side effects, such as numbness and erythema, were similar. There were no adverse events. CONCLUSION: This clinical study of a prototype medium-sized vacuum applicator with a cooled contoured surface indicates that the CoolCup produces equivalent safety and efficacy to the standard CoolCore cryolipolysis applicator. With a 42% reduction in treatment time, the procedure was found to be more comfortable because of lower vacuum skin tension and shorter treatment duration. Lasers Surg. Med. 49:63-68, 2017. © 2016 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

Lasers and Energy-Based Devices in Men.

BACKGROUND: The demand for cosmetic treatments with lasers and energy-based devices has increased among men, but there is a dearth of literature that addresses the approach and treatment of cosmetic male patients. OBJECTIVE: To summarize common cosmetic concerns for which male patients seek cosmetic treatments and to provide sex-specific recommendations for the lasers and energy-based devices that can be used for treatment. MATERIALS AND METHODS: The authors conducted a literature search using the PubMed/MEDLINE and Google Scholar databases using the search terms male, men, gender, and cosmetic dermatology. RESULTS: The authors review sex-specific treatment recommendations regarding the use of lasers and energy-based devices for the conditions for which men most commonly seek cosmetic treatment, which include photo-/actinic damage, acne scarring, rhinophyma, hair removal, axillary hyperhidrosis, and loose neck/submental skin. Cosmetic issues the authors will touch on, but whose approaches or considerations vary less in men compared with women, are hyperpigmentation, vascular lesions, and facial rejuvenation. CONCLUSION: Sex-specific treatment approaches with lasers and energy-based devices should be used to best serve male cosmetic patients.

ASDS Guidelines Task Force: Consensus Recommendations Regarding the Safety of Lasers, Dermabrasion, Chemical Peels, Energy Devices, and Skin Surgery During and After Isotretinoin Use.

BACKGROUND: Currently, the isotretinoin (13-cis-retinoic acid) package insert contains language advising the discontinuation of isotretinoin for 6 months before performing cosmetic procedures, including waxing, dermabrasion, chemical peels, laser procedures, or incisional and excisional cold-steel surgery. It is common practice to follow this standard because of concerns regarding reports of sporadic adverse events and increased risk of scarring. OBJECTIVE: To develop expert consensus regarding the safety of skin procedures, including resurfacing, energy device treatments, and incisional and excisional procedures, in the setting of concurrent or recent isotretinoin use. MATERIALS AND METHODS: The American Society for Dermatologic Surgery authorized a task force of content experts to review the evidence and provide guidance. First, data were extracted from the literature. This was followed by a clinical question review, a consensus Delphi process, and validation of the results by peer review. RESULTS: The task force concluded that there is insufficient evidence to justify delaying treatment with superficial chemical peels and nonablative lasers, including hair removal lasers and lights, vascular lasers, and nonablative fractional devices for patients currently or recently exposed to isotretinoin. Superficial and focal dermabrasion may also be safe when performed by a well-trained clinician.

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.

Three-Dimensional Rejuvenation of the Décolletage.

BACKGROUND: Photodamaged skin of the chest is characterized by skin laxity, lines/wrinkles, hyperpigmentation, erythema, tactile roughness, atrophy, and telangiectasias. METHODS: A MEDLINE search was performed on combination treatments in chest rejuvenation, and the results are summarized. Practical applications for these combinations of procedures are discussed. RESULTS: Reports of injectable poly-L-lactic acid (PLLA), hyaluronic acid (HA), and chemical peels, along with lasers and light therapies such as intense pulsed light (IPL), vascular lasers, photodynamic therapy (PDT), nonablative fractionated lasers (NAFLs), ablative fractionated lasers (AFLs), and microfocused ultrasound (MFU) have been reported for chest rejuvenation. Few articles were discovered pertaining to combination therapy. The authors review their approaches to combination therapy. CONCLUSION: Multiple options exist alone or in combination for minimally invasive rejuvenation of the skin of the chest including PLLA, HA, chemical peels, IPL, vascular lasers, PDT, NAFL, AFL, and MFU. Little was found in the literature pertaining to the safety and efficacy of combining such procedures and devices. The authors' experience in clinical practice is that combination, same day chest rejuvenation techniques can be performed safely. A combination approach often produces the most optimal outcome for the patient seeking chest rejuvenation.

ASDS Cosmetic Dermatologic Surgery Fellowship Milestones.

BACKGROUND: The American Council of Graduate Medical Education, which oversees much of postgraduate medical education in the United States, has championed the concept of "milestones," standard levels of achievement keyed to particular time points, to assess trainee performance during residency. OBJECTIVE: To develop a milestones document for the American Society for Dermatologic Surgery (ASDS) Cosmetic Dermatologic Surgery (CDS) fellowship program. METHODS: An ad hoc milestone drafting committee was convened that included members of the ASDS Accreditation Work Group and program directors of ASDS-approved Cosmetic Dermatologic Surgery (CDC) fellowship training programs. Draft milestones were circulated through email in multiple rounds until consensus was achieved. RESULTS: Thirteen milestones were developed in the 6 Accreditation Council for Graduate Medical Education (ACGME) competency areas, with 8 of these being patient-care milestones. Additional instructions for milestone administration more specific to the CDS fellowship than general ACGME instructions were also approved. Implementation of semiannual milestones was scheduled for the fellowship class entering in July 2018. CONCLUSION: Milestones are now available for CDS fellowship directors to implement in combination with other tools for fellow evaluation.

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.

Bacterial infections following non-ablative fractional laser treatment: a case series and discussion.

Non-ablative fractional laser procedures have become increasingly popular since their introduction in 2004. The fractional 1,927 nm thulium laser is a non-ablative device that penetrates up to 300 µm in the skin and the 1,550 nm erbium:glass laser penetrates up to 1,400 µm. These procedures are considered minimally invasive with a high safety profile; therefore, infectious complications are exceedingly rare. However, we report five recent cases of bacterial infection with both gram-positive and gram-negative organisms following treatment with the fractional 1550/1927 nm laser approximately 1 day to 1 week post-procedure. One patient had a rapidly progressing pustular eruption with symptoms of sepsis. These patients were seen immediately, cultures were obtained and empiric antibiotic therapy was initiated. They recovered without long-term complications. Rapid-onset bacterial infections following non-ablative laser resurfacing with the 1550/1927 nm laser have not been previously reported in the literature. The infections can progress quickly and lead to serious sequelae, including systemic illness and severe scarring, if not identified and appropriately treated. We present these cases to highlight the importance of close surveillance and when appropriate, rapid intervention, following non-ablative fractional procedures, especially when patients present with atypical symptoms and signs.

A prospective multicenter pilot study of the safety and efficacy of microfocused ultrasound with visualization for improving lines and wrinkles of the décolleté.

BACKGROUND: A previous pilot study demonstrated microfocused ultrasound with visualization (MFU-V) to lift and tighten the décolleté produced significant and durable aesthetic improvements. OBJECTIVE: To further evaluate the safety and effectiveness of MFU-V for improving lines and wrinkles of the décolleté in a larger patient population. MATERIALS AND METHODS: Healthy women with moderate-to-severe décolleté skin lines and wrinkles were enrolled. After obtaining digital images, MFU-V was administered using 3 transducers emitting ultrasound at frequencies of 4 MHz and a focal depth of 4.5 mm, 7 MHz/3.0 mm, and 10 MHz/1.5 mm. During the procedure, 280 lines of discrete thermal coagulative points 25 mm long and 2 to 3 mm apart were applied to the treatment area. Additional imaging for masked assessments and live assessments were completed at 90 and 180 days. RESULTS: Among the evaluable subjects, 77 (66.4%) demonstrated aesthetic improvement at 180 days based on blinded assessments. Approximately, 75% and 65% of treated subjects demonstrated some degree of improvement at 90 and 180 days, respectively, and most were satisfied with treatment outcomes. Adverse events were generally mild. CONCLUSION: A single MFU-V treatment provided significant aesthetic improvement for moderate-to-severe décolleté lines and wrinkles for at least the 180-day duration of the study.

Mitomycin C in the treatment of keloids: a case and review.

Mitomycin C (MMC) is an antineoplastic antibiotic that has been used off-label in the treatment of hypertrophic scars and keloids. Herein we report our successful use of this agent in a patient with sternal keloids refractory to other means of therapy. We further review the literature regarding the use of MMC in the treatment of keloids.

The new age of noninvasive facial rejuvenation.

The techniques of noninvasive facial rejuvenation are forever being redefined and improved. This article will review historical as well as present approaches to resurfacing, discussing the nonablative tools that can complement resurfacing procedures. Current thoughts on the pre- and postoperative care of resurfacing patients are also considered.

Long-term clinical evaluation of a 800-nm long-pulsed diode laser with a large spot size and vacuum-assisted suction for hair removal.

BACKGROUND: The long-pulsed diode (800-810-nm) laser is one of the most commonly used and effective lasers for hair removal. Limitations of currently available devices include a small treatment spot size, treatment-associated pain, and the need for skin cooling. OBJECTIVE: To evaluate the long-term hair reduction capabilities of a long-pulsed diode laser with a large spot size and vacuum assisted suction. METHODS: Thirty-five subjects were enrolled in a prospective, self-controlled, single-center study of axillary hair removal. The study consisted of three treatments using a long-pulsed diode laser with a large spot size and vacuum-assisted suction at 4- to 6-week intervals with follow-up visits 6 and 15 months after the last treatment. Hair clearance was quantified using macro hair-count photographs taken at baseline and at 6- and 15-month follow-up visits. Changes in hair thickness and color, levels of treatment-associated pain, and adverse events were additional study endpoints. RESULTS: There was statistically significant hair clearance at the 6 (54%) and 15-month (42%) follow-up visits. Remaining hairs were thinner and lighter at the 15-month follow-up visit, and the majority of subjects reported feeling up to mild to moderate pain during treatment without the use of pretreatment anesthesia or skin cooling. CONCLUSIONS: A long-pulsed diode laser with a large spot size and vacuum-assisted suction is safe and effective for long-term hair removal. This is the largest prospective study to evaluate long-term hair removal and the first to quantify decreases in hair thickness and darkness with treatment.