Melasma treatment with a 1064 nm, picosecond-domain laser with a fractionated multibeam lens array.

BACKGROUND AND OBJECTIVES: Picosecond-domain lasers have been fitted with fractionated optics for dermal remodeling. This study evaluates the safety and efficacy of a multiwavelength picosecond-domain laser, using a 1064 nm multibeam lens array, for improving the appearance of melasma. STUDY DESIGN/MATERIALS AND METHODS: Twenty adults with a clinical diagnosis of melasma were enrolled and received 4 monthly 1064-nm, 450 ps laser treatments delivered with a 10 × 10 fractional array of 150 µm microbeams. Cosmetic units with melasma were treated with fluences ranging from 1.7 to 2.9 mJ/microbeam with a repetition rate of 6 Hz. Treatment effect was evaluation of digital images by dermatologists blinded as to the treatment conditions, comparing baseline and 3- and 8-month post-treatment images. Modified melasma area and severity index (mMASI) scores were determined by the study investigator based on clinical photography. Subject self-assessment of treatment effects was also recorded. RESULTS: Blinded reviewers correctly identified the post-treatment image in 16 of the 20 image sets (80%). Ratings demonstrated statistically significant (p < 0.001) improvement on an 11-point scale at both the 3- and 8-month timepoints for a mean improvement of 3.7 point (range -8 to 10) or 37% improvement at the 3-month follow-up, and 2.7 (range -8 to 9) or 27% at the 8-month follow-up for all subjects. The average mMASI score showed highly significant reduction at both the 3- and 8-month follow-ups compared to baseline (p < 0.01). Most subjects (90%) were satisfied with the treatment outcome in melasma at both follow-ups, which is consistent with the treatment outcome and mMASI scores. CONCLUSION: The fractionated, picosecond-domain, 1064 nm laser is safe and effective for improving melasma and should be considered as an adjunct to topical treatment regimens and sun-protection for management of melasma.

A new 532 nm, variable-pulse-structure, dual-wavelength, KTP laser incorporating cryogen spray cooling, effectively treats rosacea.

BACKGROUND: A new dual-wavelength, high-energy, solid-state laser incorporating both 532 and 1064 nm wavelengths was developed with cryogen spray cooling and the unique ability to deliver three types of pulse structures including single pulses of a specific pulse-duration or pulses composed of a train of subpulses in the millisecond or microsecond domain with an intervening delay over the selected pulse-duration. We investigate the efficacy of this laser using all three pulse structures and the 532 nm wavelength for treating rosacea. METHODS: Twenty-one subjects were enrolled in this IRB-approved study. A total of up to three treatments were administered at monthly intervals. Each treatment consisted of a first pass tracing linear vessels with a 40 ms pulse-duration immediately followed by a second pass using a 5 ms pulse, using all three available pulse structures. Assessment of cross-polarized digital images by blinded physician observers compared baseline and 3-month follow-up images. RESULTS: Blinded observers correctly identified the posttreatment images 89% of the time, in 17 of 19 subjects completing the study, with an average overall improvement rating of 39% after only three treatments. Side effects were limited to short-term erythema and edema. CONCLUSION: This study demonstrates that this new, variable-pulse-structure, dual wavelength, solid state, KTP laser with dynamic cooling is a safe and effective for treating rosacea.

Low-fluence treatment with a novel fractionated 2,910-nm fiber laser improves photodamage.

BACKGROUND: Facial rejuvenation by lasers that target water has been a mainstay of esthetic laser treatments for decades. Modern lasers more commonly treat a fraction of the skin surface using ablative, semi-ablative, or nonablative pulses. METHODS: Twenty subjects with visible evidence of chronic photoaging on the face were enrolled in this study. All subjects received two full-face, single-pass treatments spaced 2 months apart with the superficial mode of a 2910 nm fiber laser with an estimated penetration depth of 10 µm, 25% coverage, delivered in a 15 mm × 15 mm square microbeam pattern. A blinded comparison of pretreatment and 3-month post-treatment images was performed. Evaluation of biopsy samples for laser-tissue effects was performed on three separate subjects and biopsies were harvested 1-day post-treatment, 1-week post-treatment, and 2-weeks post-treatment. RESULTS: Blinded evaluation of digital images revealed an average improvement score of 25.1 ± 14.5 (mean ± SEM) or 25.1%, using an 11-point scale evaluating overall improvement in photoaging (p < 0.001). Post-treatment effects were limited to mild-to-moderate erythema and edema, and the pain was rated a 1.9 out of a maximum of 10. Histology demonstrated superficial changes in the stratum corneum and epidermis with dermal inflammation present at 1-day post-treatment and 1-week post-treatment, with a return to baseline at 2 weeks. CONCLUSIONS: The 2910 nm fiber laser is safe and effective for improving mild photodamage, with minimal discomfort and downtime. Dermal inflammation results from very superficial epidermal injury and may contribute to clinical improvement.

A laser platform incorporating a novel 524 nm laser pumped by a commercial hair removal laser effectively treats facial redness and lower-extremity spider veins.

BACKGROUND AND OBJECTIVES: Treatment of vascular lesions is one of the main applications of cutaneous laser technology, while the other is laser hair removal. We present here a vascular laser pumped by a commercial hair removal laser. STUDY DESIGN/MATERIALS AND METHODS: A novel 524 nm vascular laser was designed using a 755 nm hair removal laser as a pumping source. This 524 nm vascular laser was used to treat facial redness and leg telangiectasias in 24 subjects. Four treatments were administered to the face at 4-6-week intervals and final photographs were taken 8 weeks following the final treatment, while two treatments were administered to lower-extremity spider veins at 2-month intervals with follow-up photographs 3 months following the final treatment. Blinded analysis of digital images was performed by two physicians not involved in the study. RESULTS: Blinded evaluation of digital photographs revealed an average improvement score of 3.3 ± 1.7 (mean ± SEM) on a 0-10 scale for removing facial redness (p < 0.001), representing a 33% improvement. Leg veins improved an average of 51% corresponding to a score of 5.1 ± 2.0 (p < 0.001). Side effects were mild and limited to erythema, purpura, edema, and one instance of mild hyperpigmentation. CONCLUSIONS: This novel 524 nm laser is safe and effective for treating vascularity on the face and legs, and proves the ability to create a laser platform incorporating a hair removal laser which then can be used as a pumping source for the attached vascular laser module.

Clinical Relevance of Elastin in the Structure and Function of Skin.

Elastin is the main component of elastic fibers, which provide stretch, recoil, and elasticity to the skin. Normal levels of elastic fiber production, organization, and integration with other cutaneous extracellular matrix proteins, proteoglycans, and glycosaminoglycans are integral to maintaining healthy skin structure, function, and youthful appearance. Although elastin has very low turnover, its production decreases after individuals reach maturity and it is susceptible to damage from many factors. With advancing age and exposure to environmental insults, elastic fibers degrade. This degradation contributes to the loss of the skin's structural integrity; combined with subcutaneous fat loss, this results in looser, sagging skin, causing undesirable changes in appearance. The most dramatic changes occur in chronically sun-exposed skin, which displays sharply altered amounts and arrangements of cutaneous elastic fibers, decreased fine elastic fibers in the superficial dermis connecting to the epidermis, and replacement of the normal collagen-rich superficial dermis with abnormal clumps of solar elastosis material. Disruption of elastic fiber networks also leads to undesirable characteristics in wound healing, and the worsening structure and appearance of scars and stretch marks. Identifying ways to replenish elastin and elastic fibers should improve the skin's appearance, texture, resiliency, and wound-healing capabilities. However, few therapies are capable of repairing elastic fibers or substantially reorganizing the elastin/microfibril network. This review describes the clinical relevance of elastin in the context of the structure and function of healthy and aging skin, wound healing, and scars and introduces new approaches being developed to target elastin production and elastic fiber formation.

The First Commercial 730 nm Picosecond-Domain Laser is Safe and Effective for Treating Multicolor Tattoos.

BACKGROUND AND OBJECTIVES: Laser-pumped lasers enable driving a secondary wavelength through pumping with a primary device. Here we investigate the first 730 nm laser-pumped laser for efficacy in tattoo removal. STUDY DESIGN/MATERIALS AND METHODS: Fifteen subjects with 20 tattoos were enrolled to investigate the effect of a new 730 nm, titanium-sapphire laser-pumped laser at removing decorative tattoos. A total of four treatments were administered and photographic improvement of pre- and post-treatment cross-polarized digital images was evaluated by four blinded physician observers using an 11-point scale. RESULTS: Blinded assessment of pre- and post-treatment images found 70%, 77%, 83%, 83%, 26%, and 8% clearance from baseline images for black, green, blue, purple, red and yellow pigments, respectively. Side effects were limited to pinpoint bleeding and erythema immediately after treatment and some crusting and scale up to 1-2 weeks following treatment, and a localized allergic reaction in a single subject. There was no scarring or pigmentary alteration visible in any follow-up images. CONCLUSION: The new 730 nm, picosecond-domain, titanium-sapphire, laser-pumped laser is safe and effective for removing multicolored tattoos. Green, blue, and purple pigments cleared the most as expected, but black ink cleared more completely than was predicted. Lasers Surg. Med. © 2020 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC.

Iron oxides in novel skin care formulations attenuate blue light for enhanced protection against skin damage.

BACKGROUND: Ultraviolet (UV) radiation is a main cause of aging of sun-exposed skin, but greater attention is being focused on the damaging effects of high-energy visible (HEV) light (400 and 500 nm). HEV light exposure has increased with expanding use of consumer electronics, such as smartphones, which have a peak emission in the 400-490 nm range. Sunscreens containing titanium dioxide and zinc oxide protect against UVA and UVB radiation but provide limited protection against HEV light. AIM: Iron oxides including red iron oxide (Fe2 O3 ), yellow iron oxide (Fe(OH)3 /FeOOH), and black iron oxide (Fe3 O4 ) effectively block HEV light, each with a different attenuation profile. Zinc oxide, titanium dioxide, and iron oxides with patented skin care ingredients have been incorporated into several formulations to provide enhanced skin protection (Colorescience, Inc). METHODS: The percent of HEV light attenuation from 400 nm to 490 nm light was measured in vitro using a technique known as diffuse transmittance spectroscopy using a Perkin Elmer Lambda™ 750 UV/Vis/NIR Spectrophotometer equipped with a 100-mm integrating Labsphere® and PbS detector. RESULTS: Products formulated with zinc oxide, titanium dioxide, and iron oxides demonstrated 71.9%-85.6% attenuation across the tested wavelengths of 415-465 nm. CONCLUSION: Sunscreens formulated with iron oxides provide enhanced protection against blue light, especially when combined with zinc oxide. To our knowledge, similar studies with iron oxides have not been performed.

Beyond sun protection factor: An approach to environmental protection with novel mineral coatings in a vehicle containing a blend of skincare ingredients.

BACKGROUND: Premature skin aging results from exposure to a range of environmental factors, primarily ultraviolet radiation, but also high-energy visible light in the blue spectrum, infrared radiation, and environmental pollution. These extrinsic factors result in the generation of reactive oxygen species which promote photoaging and DNA damage resulting in skin cancers. AIMS: To formulate skincare products utilizing a new coating applied to zinc oxide and titanium dioxide particles and complimentary skincare ingredients to provide broad protection against a range of environmental insults. METHODS: A cross-polymer, multifunctional coating of silicate, polyalkylsilsesquioxane, and polydimethylsiloxane moieties increases the photostability and decreases the reactivity of mineral sunscreen agents when interacting with energy sources. These products are also formulated with antioxidants to minimize free radical propagation. Additionally, this coating improves the esthetic feel of mineral sunscreens, while the appearance is enhanced by formulating products with a blend of iron oxides. RESULTS: A series of in vitro and ex vivo studies demonstrated the ability of mineral-based products formulated with the new multifunctional coating to provide protection against ultraviolet radiation, high-energy visible light, infrared radiation, and environmental pollution. CONCLUSION: Newly formulated mineral-based skincare products provide environmental protection, are ecologically safe, and can replace chemical-based sunscreen ingredients.

Treatment of poikiloderma of Civatte using a redesigned pulsed dye laser with a 15 mm diameter treatment spot.

OBJECTIVES: The pulsed-dye laser has long been a gold standard in the treatment of poikiloderma of Civatte. Recent advances in pulsed dye laser technology enable output energies 50% higher, enabling beam diameters of up to 15 mm with clinically relevant fluences. In this study, we investigate this new laser for treatment of this condition. MATERIALS AND METHODS: Twenty subjects were enrolled in the study. A total of four treatments were administered at monthly intervals. Blinded assessment of digital, cross-polarized photographs taken at baseline and two months following the last treatment was performed by blinded physician raters using an 11-point clearance scale. Subject reported pain scores immediately following treatment and side effects at all visits were recorded by the investigator. RESULTS: Seventeen subjects completed the study. Blinded reviewers correctly identified the baseline photo in 48 of 51 cases (94%). All three reviewers mis-identified the same subjects. The blinded reviewers scored 14 out of the 17 subjects with an improvement greater than 40% and 10 out of the 17 subjects greater than 50%. Average improvement was 49% for all 17 subjects. Side effects were limited to mild edema, and mild to moderate erythema and purpura. Pain scores averaged 3.5 on using an 11-point scale. CONCLUSION: This study demonstrates the safety and effectiveness of a new pulsed-dye laser with a 15 mm spot and 50% higher fluences for the treatment of poikiloderma of Civatte. Lasers Surg. Med. 51:54-58, 2019. © 2018 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

A novel titanium sapphire picosecond-domain laser safely and effectively removes purple, blue, and green tattoo inks.

BACKGROUND: Green, blue, and purple tattoo pigments are often the colors most resistant to laser removal. Recently, the first ever production picosecond-domain laser with a 785 nm wavelength was developed to improve the rate of clearance of green, blue, and purple tattoo inks. METHODS: Twenty-two tattoos from 15 subjects with skin phototypes II-IV were enrolled in the study. A total of four treatments were administered using a single 785 nm picosecond-domain laser wavelength. Blinded assessment of digital, cross-polarized photographs taken approximately 8 weeks following the last treatment was performed using an 11-point clearance scale. RESULTS: Fourteen subjects with 21 tattoos completed all study visits. The 21 tattoos contained the following pigments: black (n = 15), green (n = 13), blue (n = 8), yellow (n = 5), purple (n = 4), and red (n = 3). Treatments were performed with a 2-4-mm beam diameter and fluences ranging from 1.1 to 3.1 J/cm2 . Blinded assessment of photographs found 85%, 81%, 74%, 61%, 11%, and 5% clearance from baseline photos for purple, blue, green, black, red, and yellow pigments, respectively. Treatments were well tolerated with typical erythema, edema and one case of pinpoint bleeding. No scarring was noted. CONCLUSION: This first study of a new 785 nm picosecond-domain laser demonstrates safe and effective removal of multicolor tattoos. Although clearance was shown for a multitude of colors including black, the 785 nm laser wavelength has special affinity to purple, blue and green tattoo pigments. Lasers Surg. Med. 9999:1-7, 2018. © 2018 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

Pulsed dye laser treatment of rosacea using a novel 15 mm diameter treatment beam.

BACKGROUND: The pulsed-dye laser has been used to treat facial redness and rosacea for decades. Recent advances in dye laser technology enable 50% higher output energies supporting 50% larger treatment areas, and beam-diameters up to 15 mm with clinically-relevant fluences. In this study, we investigate this novel pulsed-dye laser using a 15 mm diameter beam for treatment of rosacea. METHODS: Twenty subjects with erythemato-telangiectatic rosacea were enrolled in the study. A total of 4 monthly treatments were administered, first treating linear vessels with a 3 × 10 mm elliptical beam, then diffuse redness with a 15-mm diameter circular beam. Blinded assessment of digital, cross-polarized photographs taken 2 months following the last treatment was performed using an 11-point clearance scale. RESULTS: Nineteen subjects completed the study. Blinded reviewers correctly identified baseline photos in 55 out of the total of 57 images (96.5%). The blinded reviewers scored 17 of the 19 subjects with an improvement greater than 40%, and 11 of the 19 subjects greater than 50%. The average improvement was 53.9%. Side effects were limited to mild edema, mild to moderate erythema, and mild to moderate bruising. CONCLUSION: This study demonstrates that a newly designed pulsed-dye laser having a novel 15-mm diameter treatment beam improves the appearance of rosacea with a favorable safety profile. Lasers Surg. Med. 50:808-812, 2018. © 2018 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

Safety and Efficacy of a 1550nm/1927nm Dual Wavelength Laser for the Treatment of Photodamaged Skin.

BACKGROUND: Fractional photothermolysis (FP) is a popular treatment option for photodamaged skin and addresses shortcomings of ablative skin resurfacing and nonablative dermal remodeling. Previous studies have demonstrated that FP using the 1550nm wavelength has led to improvement of ultrastructural changes and clinical effects associated with photodamaged skin in the deeper dermal structures, while treatment with the 1927nm wavelength has shown clinical effects in the superficial dermis. Both wavelengths produce precise microscopic treatment zones (MTZs) in the skin. The two wavelengths used in combination may optimize the delivery of fractional nonablative resurfacing intended for dermal and epidermal coagulation of photodamage skin.

OBJECTIVES: To evaluate the safety and efficacy of a 1550/1927 Laser System (Fraxel Dual, Solta), using both 1550nm and 1927nm wavelengths in combination for treatment of facial and non-facial photodamage.

METHODS: Prospective, multi-center, post-market study in subjects with clinically identifiable photodamage (N=35) (Fitzpatrick skin types I-IV). Both 1550nm and 1927nm wavelengths were used at each treatment visit. Investigator assessment of the affected area(s) occurred at one week, one month and 3 months after a series of up to four treatments. Severity of adverse events (AEs) were assessed using a 4-point scale (where 0=none and 3=marked). Assessments included erythema, edema, hyperkeratosis, hyper- and hypo-pigmentation, scarring, itchiness, dryness, and flaking. Severity of photoaging, fine and coarse wrinkling, mottled hyperpigmentation, sallowness, and tactile roughness at baseline was assessed using the same scale. Investigators and subjects assessed overall appearance of photodamage and pigmentation based on a 5-point quartile improvement scale at all follow-up visits (where 0=no improvement and 4=very significant improvement [76%-100%]).

RESULTS: There was a positive treatment effect at all study visits, with moderate improvement (average reduction in severity of 21%-43%) observed 3-months after final treatment. Greatest reduction in severity of other benefit areas was at the 3-month follow-up visit, with a 21% and 30% decrease in severity in fine wrinkling and tactile roughness. No AEs or serious AEs were reported. Pain sensation during treatment was tolerable. Anticipated moderate erythema (mean score 1.6±0.5) and mild edema (mean score 0.8±0.7) were transient and resolved within 7-10 days. Anticipated and transient mild dryness (52% of subjects) and flaking (30%) were reported at the 1-week follow-up. There were no incidences of hyperkeratosis, scarring, or itchiness.

CONCLUSION: Treatments using both wavelengths associated with the combined 1550/1927 Laser System were well tolerated with limited, transient anticipated side effects and no serious AEs. Clinical efficacy in the appearance of photodamage and pigmentation was greatest following a series of up to 3 treatments.

J Drugs Dermatol. 2018;17(1):41-46.

Treatment of Photoaging With a Dual-Wavelength, 532 nm and 1,064 nm Picosecond-Domain Laser Producing a Fractionated Treatment Beam Using a Holographic Optic.

BACKGROUND: A dual-wavelength, picosecond-domain, fractionated laser delivering 1,064nm and 532nm laser energy through a holographic optic was investigated for safety and effectiveness at improving the appearance of chronic photoaging. MATERIALS AND METHODS: A total of 27 subjects were enrolled with 24 completing the study, and 14 subjects were treated with 1,064 nm and 10 with 532 nm. The 1,064 nm-treated subjects received 5 monthly treatments while the 532 nm-treated subjects received 4 monthly treatments. Improvement was measured by blinded evaluation of pre- and post-treatment images 12 weeks following the final treatment. Subjects also evaluated treatment effect and side-effects. RESULTS: Blinded reviewers correctly identified the baseline image in 52 of 72 paired images, or 72% of the time, with a mean improvement score of 1.4 using an 11-point rating scale (P less than 0.0001). Post-treatment erythema, mild edema, and petechiae were the only side effects noted. CONCLUSION: The fractionated, picosecond-domain, 532 nm and 1,064 nm laser is safe and effective for improvement of facial photodamage. The laser was well tolerated with mild erythema, edema, and petechiae as the most common side-effects.

J Drugs Dermatol. 2017;16(11):1077-1082.

NEWS, VIEWS, AND REVIEWS: A Tool for My Laser Practice I Simply Can't Do Without: Shining a Light on My Favorite Light (Source).

With laser surgery, what you see is what you get. Visualizing the target for treatment, be it a port-wine stain, a cluster of spider veins, a tattoo or freckles, or simply photodamaged skin requires seeing through surface reflections, dry skin, and often quite dark laser goggles. The tool that has been indispensable to me in my practice is the Syris v900L polarizing and magnifying headlamp. This indispensable tool makes laser treatment more precise, effective, and easier by truly shining a light on the subject of a laser treatment. Future uses of this dynamic, yet simple invention, should be found in all of dermatology and beyond, anywhere that seeing what you are looking at more clearly is important.

J Drugs Dermatol. 2017;16(9):939-944.

Treatment of acne scarring with a novel fractionated, dual-wavelength, picosecond-domain laser incorporating a novel holographic beam-splitter.

BACKGROUND AND OBJECTIVES: Fractional treatment with a dual wavelength 1,064 and 532 nm picosecond-domain laser, delivering a 10 × 10 array of highly focused beamlets via a holographic optic, was investigated for the treatment of acne scars. STUDY: Twenty-seven of 31 subjects completed the study, 19 were treated using 1,064 nm and 8 were treated at 532 nm, all having four-monthly treatments. Blinded evaluation of digital images by three physician evaluators comparing pre- and 3-month post-treatment images measured efficacy using a 10-point scale. Subject self-assessment of treatment effects were also recorded. Safety was measured by recording subject discomfort scores and adverse effects. RESULTS: Blinded reviewers correctly identified the baseline image in 61 of the 81 image sets (75%), and baseline acne scar scores were 1.8 ± 0.7 and 1.8 ± 0.5 for the 1,064 and 532 nm cohorts, and decreased to 1.1 ± 0.5 (P < 0.001) and 1.1 ± 0.0 (P < 0.005), respectively. Post-treatment erythema, mild edema, and petechiae were the only side effects noted. CONCLUSION: The 1,064 and 532 nm picosecond-domain laser incorporating a 10 × 10 holographic beam-splitting handpiece was found to be safe and effective for the treatment of facial acne scars. The treatments were well tolerated and the subjects experienced little to no downtime. Lasers Surg. Med. 49:796-802, 2017. © 2017 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

Safety and Efficacy of Bilateral Submental Cryolipolysis With Quantified 3-Dimensional Imaging of Fat Reduction and Skin Tightening.

IMPORTANCE: Cryolipolysis is a popular, well-tolerated nonsurgical procedure that uses controlled cooling to selectively destroy fat cells. Central submental cryolipolysis has been reported to be safe and effective, but many patients would benefit from extending this treatment over the entire submental region. OBJECTIVE: To investigate the safety and efficacy of cryolipolysis for reduction of lateral and central submental fat. DESIGN, SETTING, AND PARTICIPANTS: The study population consisted of 14 participants who were treated from January 22 to June 30, 2016, in the lateral and central submental area to reduce unwanted subcutaneous fat. A small-volume cup applicator was used to administer 2 cryolipolysis treatments, delivered in 45-minute treatment cycles in 2 sessions. For the first treatment session, all participants received bilateral treatments with approximately 20% overlap of the treatment area. At the 6-week follow-up visit, participants were reassessed to determine whether they would benefit from a second treatment and to determine the number of cycles needed to achieve the optimal aesthetic result, and then they were treated a second time. MAIN OUTCOMES AND MEASURES: Participant surveys assessed tolerability and treatment satisfaction at 12 weeks following the second treatment. Clinicians monitored adverse events to assess safety. Caliper measurements were recorded to assess fat thickness reduction. Treatment efficacy was objectively evaluated using 2-dimensional and 3-dimensional imaging. RESULTS: Among the 14 participants (12 women and 2 men; mean [SD] age, 50.5 [10.4] years), the adverse effects of the procedure were typically mild and included numbness and tingling, which resolved without intervention by the final 12-week follow-up visit. An independent review of digital photographs revealed an 81.0% (95% CI, 65.9%-91.4%; P = .02) correct identification rate (34 of 42 images) of the pretreatment and posttreatment images. Caliper measurements demonstrated a mean (SD) fat layer reduction of 2.3 (0.8) mm (range, 0.7-3.5 mm). Three-dimensional imaging revealed a mean (SD) reduction in fat volume of 4.82 (11.42) cm3 (from a reduction of 32.69 cm3 to an increase of 13.85 cm3), in skin surface area of 1.29 (1.42) cm2 (from a reduction of 3.18 cm2 to an increase of 0.99 cm2), and in fat thickness of 3.77 (3.59) mm (from of reduction of 13.10 mm to an increase of 0.47 mm). Results of participant surveys indicated that 13 participants (93%) were satisfied with the cryolipolysis treatment. CONCLUSIONS AND RELEVANCE: Although safe and efficacious central submental cryolipolysis has been reported, this is the first clinical study of cryolipolysis for treatment of the entire submental area using overlapping bilateral treatments and a shorter treatment duration. The study demonstrates that bilateral submental cryolipolysis is well tolerated and produces visible and significant fat layer reduction. LEVEL OF EVIDENCE: 4.

Long-term efficacy follow-up on two cryolipolysis case studies: 6 and 9 years post-treatment.

Cryolipolysis is a noninvasive esthetic procedure that utilizes controlled cooling to reduce subcutaneous fat. Clinical studies have established its safety, efficacy, and tolerability for fat reduction in a variety of areas including the abdomen, flanks, thighs, submental area, arms, back, and chest. Because of obvious esthetic concerns, long-term unilateral studies leaving an untreated flank, thigh, or arm are not performed, but serve as ideal controls for weight gain or loss or re-distribution of fat for other reasons. This article follows two patients previously documented in a case report to demonstrate their ongoing treatment efficacy at 6 and 9 years after treatment. Clinical photographs of the treated flanks and untreated contralateral controls demonstrate long-term durability in these two subjects.