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Background Cellulite is an aesthetic condition affecting the appearance of skin in certain body regions and is associated with body dissatisfaction, psychosocial stress, and decreased quality of life. Previous studies established the safety and feasibility of a novel, minimally invasive device to identify and release septa responsible for cellulite depressions: targeted verifiable subcision (TVS). Objectives The objective of this single-arm, open-label, multicenter study was to evaluate the safety and efficacy of TVS for reducing the appearance of moderate to severe cellulite in adult women. Methods Adult women aged 21 to 55 years and a BMI Results Seventy-four female participants with a mean BMI of 24.8 ± 2.7 and age of 41.4 ± 7.4 years received this single procedure. The mean improvement in Cellulite Severity Scale (N = 68) was 1.5 ± 0.9 (P Conclusions TVS for selectively identifying and verifiably releasing septa responsible for cellulite depressions is an effective and safe means to improve the appearance of moderate to severe cellulite in adult women. Level of Evidence: 2

Given differences in buttock versus thigh cellulite, collagenase clostridium histolyticum-aaes (CCH-aaes) injection technique may impact treatment effects at these sites.To evaluate efficacy and safety of 5 CCH-aaes injection techniques.A phase 2A, open-label trial enrolled women with mild-to-severe cellulite (Clinician Reported Photonumeric Cellulite Severity Scale) on both buttocks or thighs. CCH-aaes 0.84 mg was administered as 12 injections in each of two buttock or two thigh treatment areas (total dose, 1.68 mg) during three treatment sessions (Days 1, 22, 43). On Day 1, women were sequentially assigned to: Technique A = shallow injection/3 aliquots; Technique B = shallow injection/1 aliquot; Technique C = deep injection/1 aliquot; Technique D = deep and shallow injections/5 aliquots; or Technique E = shallow injection/4 aliquots. Change from baseline in Hexsel Cellulite Severity Scale (CSS) depression depth (range, 0 [no depressions] to 3 [deep depressions]) was assessed at Day 71. Safety was evaluated via adverse events.Sixty-three women with buttock (n = 31) or thigh (n = 32) cellulite received ≥1 CCH-aaes dose. For buttock cellulite, CCH-aaes injection Technique A resulted in the greatest baseline-adjusted improvement in CSS score on Day 71 (least-squares mean, 1.17-point improvement). For thigh cellulite, CSS score improvement was greatest with Technique D (least-squares mean, 1.40-point improvement). CCH injection Techniques A, D, and E were associated with more favorable safety profiles than Techniques B and C.Different CCH-aaes injection techniques are required with buttock (Technique A) versus thigh (Technique D) cellulite to optimize treatment outcomes.

Background HARC is a soft and flexible hyaluronic acid filler containing lidocaine, manufactured using XpresHAnrntechnology, restoring natural-looking volume and soft contours. Objectives To evaluate safety and effectiveness of HARCnfor cheek augmentation and correction of midface contour deficiencies compared to a control product HAJV (hereafter referred to as Control). Primary objective was to demonstrate non-inferiority of HARCncompared to the Control, by blinded evaluation of change from baseline in midface fullness 12 weeks after last injection, using a 4 grade midface volume scale (MMVS). Materials and methods Subjects over the age of 21 with loss of fullness in the midface area (MMVS score 2, 3, or 4) were randomized 2:1 to treatment with HARC(n=142) or Control (n=68). Optional touch-up was allowed after 4 weeks. Study assessments included MMVS, aesthetic improvement, subject satisfaction, and safety. Subjects were followed for 48 weeks. Results Overall, most subjects were female (89%) and mean age was 53 years (range 24-80). Total mean volume injected was 4.3 mL for HARCnand 4.9 mL for Control. Primary objective was met; mean change from baseline in MMVS score at week 12: -1.4 (HARC), -1.3 (Control), 95% CI: -0.22, 0.06. HARCneffectiveness was supported by a high degree of aesthetic improvement and subject satisfaction throughout 48 weeks. Related adverse events were generally mild and transient. Conclusions nHARCnwas well tolerated and non-inferior to Control for correction of midface fullness at 12 weeks after last injection. Aesthetic improvement and subject satisfaction were high and lasted through week 48. nJ Drugs Dermatol. 2021;20(9):949-956. doi:10.36849/JDD.6191.

Background Safety and efficacy endpoints for the single-arm, multicenter, open-label pivotal study, CONtrolled Focal Fibrous Band Release Method (CONFFIRM) [NCT04743635] assessing targeted verifiable subcision (TVS) for the treatment of cellulite were met at 3 months postprocedure and have been published. Final, 12-month data describing durability of treatment effect and safety are presented here for the first time. Objectives The authors sought to evaluate safety and efficacy out to 12 months of initial treatment for a single TVS procedure performed employing the Avéli device (Revelle Aesthetics, Inc.; Mountain View, CA) to treat cellulite on the buttock and thigh areas of adult females. Methods Effectiveness was determined by 3 independent physicians employing the Cellulite Severity Scale and Global Aesthetic Improvement Scale to assess improvement of baseline photographs when compared with 3-, 6- and 12-month posttreatment photographs. Blinded participant-reported outcomes and safety evaluations were also performed at all postprocedure time points. Results Clinically significant improvement in primary endpoint Cellulite Severity Scale scores were sustained out to 1 year, improving by 1.50 (P < .0001) at 3 months, 1.54 points at 6 months, and 1.48 points at 12 months. Adverse events were mild and mostly resolved by the 12-month visit. Conclusions A single TVS treatment has durable efficacy and safety in reducing cellulite on the buttocks and thighs of women with moderate to severe cellulite out to 12 months posttreatment. Level of Evidence: 2

Introduction and objectives Surface depressions and skin laxity together play a role in the appearance of cellulite. Cellulite depressions can be improved through disruption of the subcutaneous fibrous structures. Some currently utilized approaches accomplish this through invasive techniques requiring local anesthesia and potential down time. Skin laxity can exacerbate the appearance of cellulite, however current invasive approaches do little to improve skin laxity. The objective of this study was to evaluate a noninvasive approach to improving both cellulite depressions and skin laxity through the use of rapid acoustic pulses (acoustic subcision). Safety, efficacy, tolerability, and participant satisfaction results were measured. Methods Women (n = 56) with moderate to severe cellulite were treated in a single acoustic subcision treatment session without anesthesia. Posttreatment adverse events (AEs) and tolerability were recorded. At 12-weeks cellulite outcomes were assessed using a 6-point simplified Cellulite Severity Scale (CSS), Global Aesthetic Improvement Scale (GAIS), and a participant satisfaction questionnaire. Additionally, laxity improvement was measured using a 4-point Laxity Score (LS) and GAIS. Results Improvement in cellulite appearance measured at 12-weeks showed that participants (n = 56) had a mean CSS reduction of 1.01 (a 29.5% reduction from baseline). The posttreatment photograph was correctly identified by blinded independent reviewers from randomized pairs of pre/posttreatment photographs for 96.4% of participants. Cellulite was graded as improved, much improved or very much improved using the GAIS at 90.9% of treated locations. Finally, 92.9% of participants reported positive satisfaction responses. Scoring for improvement in skin laxity appearance at 12-weeks showed a mean LS reduction of 0.57 (a 27.9% reduction from baseline). GAIS for laxity was graded as improved, much improved or very much improved in 67.3% of treated areas. No unexpected or serious AEs were noted at treatment or follow-up. Overall average pain score during treatment was 2.4 (0-10 pain scale) and 0.3 immediately posttreatment. Conclusion A single noninvasive acoustic subcision session can safely provide meaningful improvement in the appearance of cellulite in terms of depressions, as well as skin laxity, with minimal treatment pain and no posttreatment down time. Further improvement in appearance is expected with multiple treatments over time. Additional trials to verify this are planned.

BACKGROUND Fibrous septae play a role in contour alterations associated with cellulite. OBJECTIVE To assess collagenase clostridium histolyticum-aaes (CCH) for the treatment of cellulite. MATERIALS AND METHODS Two identically designed phase 3, double-blind, randomized studies (RELEASE-1 and RELEASE-2) were conducted. Adult women with moderate/severe cellulite (rating 3–4 on the Patient Reported Photonumeric Cellulite Severity Scale [PR-PCSS] and Clinician Reported PCSS [CR-PCSS]) on the buttocks received up to 3 treatment sessions of subcutaneous CCH 0.84 mg or placebo per treatment area. Composite response (≥2-level or ≥1-level improvement from baseline in both PR-PCSS and CR-PCSS) was determined at Day 71. RESULTS Eight hundred forty-three women received ≥1 injection (CCH vs placebo: RELEASE-1, n = 210 vs n = 213; RELEASE-2, n = 214 vs n = 206). Greater percentages of CCH-treated women were ≥2-level composite responders versus placebo in RELEASE-1 (7.6% vs 1.9%; p = .006) and RELEASE-2 (5.6% vs 0.5%; p = .002) and ≥1-level composite responders in RELEASE-1 (37.1% vs 17.8%; p < .001) and RELEASE-2 (41.6% vs 11.2%; p < .001). Most adverse events (AEs) in the CCH group were injection site related; few CCH-treated women discontinued because of an AE (≤4.3%). CONCLUSION Collagenase clostridium histolyticum-aaes significantly improved cellulite appearance and was generally well tolerated.

Supplemental Digital Content is Available in the Text., BACKGROUND The etiology of cellulite is unclear. Treatment of cellulite has targeted adipose tissue, dermis, and fibrous septae with varying degrees of success and durability of response. OBJECTIVE Results from clinical trials that target different anatomical aspects of cellulite can provide insights into the underlying pathophysiology of cellulite. MATERIALS AND METHODS A search of the PubMed database and ClinicalTrials.gov website was conducted to identify clinical trials that have investigated treatments for cellulite. RESULTS A lack of trial protocol standardization, objective means for quantification of improvement and reported cellulite severity, and short-term follow-up, as well as variation in assessment methods have made comparisons among efficacy studies challenging. However, the lack of durable efficacy and inconsistency seen in clinical results suggest that dermal or adipose tissue changes are not the primary etiologies of cellulite. Clinical studies targeting the collagen-rich fibrous septae in cellulite dimples through mechanical, surgical, or enzymatic approaches suggest that targeting fibrous septae is the strategy most likely to provide durable improvement of skin topography and the appearance of cellulite. CONCLUSION The etiology of cellulite has not been completely elucidated. However, there is compelling clinical evidence that fibrous septae play a central role in the pathophysiology of cellulite.

Background Cellulite is the dimpled appearance of skin that commonly occurs on the buttocks and thighs of postpubertal women. Cellulite can be emotionally distressing, causing many individuals to seek medical attention. A previous first-in-human study established the safety and feasibility of a novel minimally invasive method for selectively identifying and manually releasing the specific septa responsible for causing cellulite depressions in a precise manner. Objectives The objective of this open-label, multicenter study was to evaluate the safety, efficacy, and feasibility of this method for reducing the appearance of moderate and severe cellulite in adult women. Methods Female patients (n = 20) 21 to 55 years old with a BMI ≤ 35 kg/m2 with moderate or severe cellulite on the buttocks and/or thighs were enrolled at 4 clinics. Patients were evaluated on posttreatment Days 7, 30, 120, and 180. The primary endpoint was a mean ≥1-point reduction in the Cellulite Severity Scale at 180 days. Results Most patients (n = 18, 95%) achieved the primary endpoint. All patients (n = 19, 100%) were rated as much improved or very much improved in Cellulite Severity Scale scores. Adverse events and investigator findings were mild and transient, and none were unexpected. Conclusions A novel method for selectively identifying and manually releasing the specific septa responsible for causing cellulite depressions in a precise manner is a safe and effective means for improving the appearance of moderate and severe cellulite in adult women with a wide variety of skin types. Level of Evidence: 4

IMPORTANCE: The demand for non-invasive methods for facial and body rejuvenation has experienced exponential growth over the last two decades. While multiple treatment systems exist, device specific guidelines to help guide clinicians to achieve the best outcomes are lacking. OBJECTIVE: To develop expert consensus on the use of 4th generation non-microneedling monopolar radiofrequency. Design: In a modified Delphi process, a panel of 8 international experts in aesthetic dermatology participated in 3 rounds of consensus building commencing in April 2019. Initially, 32 consensus statements were developed addressing patient selection, patient outcomes, treatment settings, and practical use of non-microneedling monopolar radiofrequency. By the 3rd round, these had been reduced and refined to a total of 19 statements. The consensus process was completed in June 2019 and the data were analyzed in July 2019. RESULTS: In 3 Delphi rounds, the 8 panelists achieved consensus on 19 recommendations on the use of 4th generation non-microneedling monopolar radiofrequency and developed additional explanatory guidance to support 12 of the consensus statements including those related to patient selection, procedural technique, and anticipated treatment outcomes. CONCLUSIONS AND RELEVANCE: Although guidelines will never replace individual clinical judgment, as the demand for noninvasive tissue tightening increases, so too does the need for positive, reproducible outcomes. Careful patient selection, pre-treatment counseling, treatment planning, and good technique, are all critical for success. These consensus statements should assist clinicians in each of these areas.

Background:. We introduce an innovative and novel technology that achieves scarless skin removal without the use of thermal energy. Microcoring technology (MCT) uses a modified, hollow hypodermic needle to remove skin safely and without a scar. This method is advantageous compared to other fractional devices, given that it has the same benefits as energy-based devices (removal of skin cores without a scar), with the added value of immediate closure along the relaxed skin tension lines, with significantly less thermal energy. Methods:. Three prospective clinical safety trials analyzing MCT treatment on abdominal and facial skin (short- and long-term) are described. Results:. MCT treatment of human skin resulted in scarless skin removal that was well tolerated by patients. Healing occurred rapidly, with limited side effects. Skin area reduction (skin tightening) and increase in skin thickness were observed long term. Conclusions:. MCT treatment of human skin is safe and well tolerated. Although further studies on efficacy are required to evaluate the full potential of MCT in skin rejuvenation, early findings such as skin tightening and increase in skin thickness are encouraging.

Collagen-rich fibrous septae and subcutaneous adipose protrusions play a role in cellulite pathophysiology. Collagenase clostridium histolyticum-aaes (CCH-aaes) injection causes enzymatic release of septae to resolve cellulite depressions and create a skin smoothing effect. This analysis pooled data from two identically designed, phase-3, randomized, double-blind, placebo-controlled studies to examine the efficacy and safety of CCH-aaes.Adult women with moderate/severe cellulite (3-4 on Clinician Reported Photonumeric Cellulite Severity Scale and Patient Reported Photonumeric Cellulite Severity Scale) on the buttocks received up to three treatment sessions (Days 1, 22, and 43) of subcutaneous CCH-aaes 0.84 mg or placebo per treatment area. Composite and individual component response (≥2-level or ≥1-level improvement from baseline in Patient Reported Photonumeric Cellulite Severity Scale and/or Clinician Reported Photonumeric Cellulite Severity Scale) and additional patient-reported outcomes were determined at Day 71.Analysis included 424 CCH-aaes-treated and 419 placebo-treated women. CCH-aaes-treated women were 5.9 times more likely than placebo-treated women to be ≥2-level composite responders at Day 71 (odds ratio [95% confidence interval], 5.9 [2.2-15.4];CCH-aaes treatment significantly improved moderate-to-severe buttock cellulite appearance and was generally well tolerated.

Background:. Injection cryolipolysis using an ice slurry has been hypothesized to be a novel method of reducing fat. The present first-in-human pilot study aims to investigate the feasibility, safety, and tolerability of ice slurry injection into human subcutaneous fat. Methods:. Preabdominoplasty subjects were recruited. Baseline measurements and serial follow-up visits following a single ice slurry injection procedure into tissue to be excised during abdominoplasty were performed. Melted ice slurry injection was used as control. Feasibility using standard injection techniques was assessed. Thermal imaging was used to determine cooling efficacy. Safety was assessed by adverse event monitoring. Tolerability was assessed by subject-reported pain score. Histology and ultrasound were monitored for structural changes associated with cryolipolysis. Results:. A single injection of ice slurry was feasible and sufficient to cool adipose below the target temperature (10C). There were no serious adverse events. The most common adverse events were bruising and erythema. The mean pain score for ice slurry-injected sites was 1.9/10 and 1.3/10 in control injection sites. Evidence of cryolipolysis was observed on ultrasound and tissue histology in ice slurry-injected sites. Conclusions:. Ice slurry injections are feasible, with an observed safety and tolerability profile comparable to topical cryolipolysis. The ice slurry can cool tissue to induce cryolipolysis, as observed by thermal imaging, ultrasound, and tissue histology, and is selective for ice-injected sites. No significant changes were observed in control sites. The ice slurry may be a promising candidate to enable more precise, effective, and customizable aesthetic fat reduction that warrants further investigation.

Background and Objectives The ability to provide improved tattoo fading using multiple laser passes in a single office laser tattoo removal session is limited. In part, this is due to the loss of laser effectiveness caused by epidermal and dermal vacuole “whitening” generated during the initial laser pass at the tattoo site. The Rapid Acoustic Pulse (RAP) device generates acoustic shock wave pulses that clear epidermal and dermal vacuoles to enable multiple laser passes in a single office laser tattoo removal session. The objectives of this study were to determine if the RAP device, when used as an accessory to the 1064 nm Nd:YAG Q‐switched (QS) laser can enable delivery of multiple laser passes in a single office laser tattoo removal session, and therefore result in increased tattoo fading compared to the clinical standard single‐pass QS laser tattoo removal session. Study Design/Materials and Methods The RAP device was evaluated in a single‐center (SkinCare Physicians), prospective, IRB approved study. A total of 32 black ink tattoos, from 21 participants, were divided into three zones and treated with either multiple QS laser passes, each followed by 1 minute of RAP device application (Laser + RAP) in zone one and single‐pass QS laser treatment (Laser‐Only) in zone two, separated by an untreated control zone. The treatment sites were assessed for the number of laser passes and adverse events immediately, 6 weeks, and 12 weeks following the treatment session. Photographs of the treatment sites were assessed for percent fading at 12 weeks post‐treatment by three blinded reviewers. Results When the RAP device was applied as an accessory to the QS laser in a multi‐pass laser tattoo removal treatment, an average of 4.2 laser passes were delivered in a single session, with no unexpected or serious RAP device‐related adverse events. At the 12‐week follow‐up, tattoos treated with Laser + RAP showed a statistically significant increase in average fading (44.2%) compared with tattoos treated with Laser‐Only (24.8%) (P 50% fading compared with tattoos treated with QS Laser‐Only (9.4%) (P 75% fading from Laser + RAP treatment (21.9%) compared with Laser‐Only treatment (3.1%) (P

Background A global approach to facial rejuvenation involves multiple treatment modalities. Objectives The aim of this study was to evaluate the impact of multimodal facial aesthetic treatment on self-reported psychological and social outcomes. Methods HARMONY, a prospective, multicenter, 4-month study, enrolled patients aged 35 to 65 years to receive on-label treatment with a combination of hyaluronic fillers (VYC-20L, HYC-24L, and/or HYC-24L+), onabotulinumtoxinA, and bimatoprost. Fillers were injected on Day 1, with touch-ups performed on Day 14. OnabotulinumtoxinA was injected at Month 3 into glabellar lines and/or crow’s feet lines. Patients applied bimatoprost to eyelashes once daily for 17 weeks. Mean change from baseline on FACE-Q Psychological Well-being and Social Confidence Scales, FACE-Q Aging Appearance Appraisal Scale, and FACE-Q Age Appraisal Visual Analog Scale were assessed. Results Of 100 patients treated, 93 were evaluated at 4 months posttreatment. Significant improvement vs baseline was observed on the FACE-Q Scales for Psychological Well-being (mean change, −19.9; P < 0.00001), Social Confidence (mean change, −18.2; P < 0.00001), and Aging Appearance (mean change, −28.5; P < 0.0001). On average, patients’ self-assessed age was 0.1 years older than actual age at baseline and 4.5 years younger at Month 4 (P < 0.001 vs baseline). Forty-two patients experienced adverse events, all mild to moderate. Conclusions Multimodal, full facial aesthetic treatment improves patients’ self-reported psychological well-being, social confidence, aging appearance, and perceptions of chronologic age. Level of Evidence: 4

Background New treatment methods for cellulite require globally accepted scales for aesthetic research and patient evaluation. Objective To develop a set of grading scales for objective assessment of cellulite dimples on female buttocks and thighs and assess their reliability and validity. Materials and methods Two photonumeric grading scales were created and validated for dimples in the buttocks in female patients: Cellulite Dimples-At Rest, and Cellulite Dimples-Dynamic. Sixteen aesthetic experts rated photographs of 50 women in 2 validation sessions. Responses were analyzed to assess inter-rater and intra-rater reliability. Results Overall inter-rater reliability and intra-rater reliability were both "almost perfect" (≥0.81, intraclass correlation efficient and weighted kappa) for the At Rest scale. For the Dynamic scale, inter-rater reliability and intra-rater reliability were "substantial" (0.61-0.80). There was a high correlation between the cellulite scales and body mass index, age, weight, and skin laxity assessments. Conclusion Consistent outcomes between raters and by individual raters at 2 time points confirm the reliability of the cellulite dimple grading scales for buttocks and thighs in female patients and suggest they will be a valuable tool for use in research and clinical practice.

Background Individuals seeking aesthetic treatment have concerns regarding multiple facial areas. Objectives Assess the aesthetic impact and satisfaction achieved with a multimodal approach to aesthetic treatment using a combination of minimally invasive treatments. Methods Prospective, multicenter, rater-blinded, 4-month HARMONY study evaluated patient satisfaction and aesthetic impact of a combination of fillers (VYC-20L, HYC-24L, and HYC-24L+), onabotulinumtoxinA, and bimatoprost. Males and females aged 35 to 65 years received on-label, staged treatment with fillers, as needed per investigator assessment, on day 1, with touch ups allowed on day 14. Bimatoprost was self-administered once daily for 17 weeks. OnabotulinumtoxinA was injected into glabellar lines, crow's feet lines, or both at month 3. Primary effectiveness measure was mean change from baseline on the FACE-Q 10-item Satisfaction with Facial Appearance Overall Scale. Results Of 100 patients treated, 93 underwent at least the 4-month posttreatment assessment and were assessed for efficacy. The FACE-Q Satisfaction with Facial Appearance Overall Scale total score increased from baseline (41.2) to month 4 (72.9; P < 0.00001; effect size, 2.7). Improvement following multimodal treatment was observed on FACE-Q individual items. Self-perceived age decreased from 0.2 years older than actual age at baseline to 4.6 years younger at month 4. Nearly all patients (99%) rated themselves as improved or much improved on the Global Aesthetic Improvement Scale. Investigator assessments also demonstrated improvement. Mild to moderate adverse events occurred in 42 patients. Conclusions Minimally invasive, multimodal treatment resulted in improvements in FACE-Q scores and perceived age, indicating a high degree of patient satisfaction and a younger facial appearance. Level of Evidence 4

Over the last 50 years, laser sources have been used in many skin diseases, and their role has been increasing in most fields of dermatology. At present, laser technology allows us to treat a variety of skin conditions, either inflammatory or neoplastic, in addition to aesthetic problems. Hence, in the last few years, surgical, vascular, selective, and other lasers have become more popular. A significant advantage of lasers is their ability to provide “noncontact surgery,” since lesion vaporization occurs without any physical contact between skin and the device. This assures sterilization and helps avoid possible infections. The different types of laser treatments have been expanding as well as laser technology. A better understanding of interactions between laser radiation and tissues has made lasers more powerful and selective for each type of lesion and aesthetic problem. Due to the specific properties of selective photothermolysis, lasers exert effects strictly limited to the treated area, avoiding any damage to the surrounding skin. This unique attribute of lasers allows physicians to treat even very small skin lesions with excellent aesthetic results. In particular, in the vascular field, dye lasers have become the gold standard in treating superficial vascular disease and are excellent for treating large lesions such as port wine stains. Pulsed dye lasers are also useful tools for the so-called unconventional treatments, such as hypertrophic scars, keloids, superficial basal cell carcinoma, and common warts. ND-Yag lasers are used for treating deep vascular lesions and hair removal. In addition, these two lasers can also be employed effectively in combination on difficult lesions, as reported by K. Vas et al., showing that sequential combined treatment with both dye and ND-Yag lasers is satisfactory for surgical scars. Another popular device is the Q-switched laser, which is effective and safe for removal of benign pigmented lesions and tattoos since it interacts with the dermal structures holding exogenous pigment. Tattoo removal may be associated with a number of cutaneous side effects, such as inflammatory or rare neoplastic skin reactions, which are described by A. Bassi et al. They highlight that early diagnosis is essential for proper treatment. Intense pulsed light is a versatile tool suitable for many different skin conditions thanks to its wide range of wavelengths, and unconventional uses are exhaustively discussed by D. Piccolo et al. The constant improvement in laser devices and technology results in the need for continuous training and evolving knowledge. For example, A. Soriani et al. highlight this concept with a study that examines the power loss of laser beams induced by various types of tissue. Since laser penetration is closely related to laser settings such as wavelength and spot diameter, they evaluate these variables in order to accurately determine the fraction of released energy in order to obtain better clinical results. Due to the increasing need for noninvasive technology for diagnosis, therapy, and follow-up, high resolution tools such as nonlinear optical microscopy and two-photon fluorescence microscopy are in depth presented by R. Cicchi et al. They evaluate possibilities to monitor the effect of therapy and topical absorption. Since the 1970s, photodynamic therapy aroused a growing interest in treating several skin diseases. E. Filonenko et al. evaluate the effectiveness of this treatment for penile in situ carcinoma, obtaining satisfactory oncological results without affecting patient quality of life. In addition, X. Wang et al. emphasize that these therapies may require long application times so that the use of an automatic medical manipulator system can increase the radiation uniformity and ensure a better therapeutic result. Due to the growing importance of laser techniques in dermatologic practice, ongoing multicenter studies will be valuable in helping us develop precise standardization of parameters used for each laser and each disease. This will improve the effectiveness of the tools and allow physicians to obtain better and more reproducible results. Silvia Moretti Michael S. Kaminer Anne Le Pillouer-Prost Piero Campolmi

Importance Common noninvasive to minimally invasive cosmetic dermatologic procedures are widely believed to be safe given the low incidence of reported adverse events, but reliable incidence data regarding adverse event rates are unavailable to date. Objective To assess the incidence of adverse events associated with noninvasive to minimally invasive cosmetic dermatologic procedures, including those involving laser and energy devices, as well as injectable neurotoxins and fillers. Design, Setting, and Participants A multicenter prospective cohort study (March 28, 2011, to December 30, 2011) of procedures performed using laser and energy devices, as well as injectable neurotoxins and soft-tissue augmentation materials, among 8 geographically dispersed US private and institutional dermatology outpatient clinical practices focused on cosmetic dermatology, with a total of 23 dermatologists. Participants represented a consecutive sample of 20 399 cosmetic procedures. Data acquisition was for 3 months (13 weeks) per center, with staggered start dates to account for seasonal variation. Exposures Web-based data collection daily at each center to record relevant procedures, by category type and subtype. Adverse events were detected by (1) initial observation by participating physicians or staff; (2) active ascertainment from patients, who were encouraged to self-report after their procedure; and (3) follow-up postprocedural phone calls to patients by staff, if appropriate. When adverse events were not observed by physicians but were suspected, follow-up visits were scheduled within 24 hours to characterize these events. Detailed information regarding each adverse event was entered into an online form. Main Outcomes and Measures The main outcome was the total incidence of procedure-related adverse events (total adverse events divided by total procedures performed), as verified by clinical examination. Results Forty-eight adverse events were reported, for a rate of 0.24% (95% CI, 0.18%-0.31%). Overall, 36 procedures resulted in at least 1 adverse event, for a rate of 0.18% (95% CI, 0.13%-0.25%). No serious adverse events were reported. Adverse events were infrequently associated with known risk factors. Conclusions and Relevance Noninvasive to minimally invasive cosmetic dermatologic procedures, including energy, neurotoxin, and filler procedures, are safe when performed by experienced board-certified dermatologists. Adverse events occur in less than 1% of patients, and most of these are minor and transient.

Not AvailableStudy supported by Allergan.

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Background Given the recent boom of the cosmetic industry, there is a wealth of new products available to patients and physicians, including soft-tissue fillers. Bio-Alcamid polyacrylamide gel (Polymekon, Milan, Italy) is a filler that has potential to cause adverse reactions. Observations Two patients who had previously been treated with Bio-Alcamid outside of the United States presented with different manifestations of inflammatory responses to the product. These reactions were challenging to treat. Conclusions Despite claims of safety, Bio-Alcamid and possibly other soft-tissue fillers available worldwide have the potential to cause adverse reactions. Physicians should be aware of the various presentations and treatment options for these reactions.

as is usual in DDD, an increasednumber ofmelanocytes was not found in our patient, unlike the patient of Kameyama et aI. Kameyama and co-workers suggest that azelaic acid more easily penetrates active melanocytes; perhaps in our patient the melanocyteswere in a less active state. It is also possiblethat the pathogenetic mechanisms in DDD and RAPK differ, especiallywith regard to tyrosinase activity and the regulation of melanocyte activity.A trial on a larger populationcoulddeterminethe responsiveness to azelaic acid of patients with reticulate pigmentation and givemore information about the pathogenesis of this interesting group of disorders.