Improvement in Cellulite Appearance After a Single Treatment Visit With Acoustic Subcision: Long-Term Findings From a Multicenter Clinical Trial.

BACKGROUND: Cellulite is an aesthetically displeasing rippling or dimpling of the skin, primarily on the buttocks/thighs. A recent study showed a novel acoustic subcision device produced significant short-term (12-week) improvement in the appearance of cellulite after a single rapid acoustic pulse (RAP) treatment. OBJECTIVE: To evaluate the long-term (>52-weeks) efficacy and safety of RAP treatment for improvement in the appearance of cellulite. MATERIALS AND METHODS: In this prospective, multicenter trial, female participants ( n = 42) with severe cellulite were treated with the acoustic subcision device in a single visit. At >52 weeks, blinded board-certified dermatologists assessed efficacy by correctly identifying post-treatment photographs and using a 6-point simplified Cellulite Severity Scale (CSS). Participant satisfaction was also collected. Safety was assessed throughout. RESULTS: The blinded panel correctly identified post-treatment photographs at a rate of 95.2%; 70.4% of participants had a >1-point reduction in the CSS score from baseline (mean reduction of 1.09). All participants (100%) reported improved cellulite appearance. Overall pain during treatment was rated as 2.4 and 0.3 post-treatment (pain scale 0-10). No device or treatment-related adverse events were reported at the >52-week follow-up. CONCLUSION: Rapid acoustic pulse treatment significantly improved the long-term appearance of cellulite and was well-tolerated.

Effectiveness and Safety of Sculptra Poly-L-Lactic Acid Injectable Implant in the Correction of Cheek Wrinkles.

BACKGROUND: The current study evaluated the effectiveness and safety of Sculptra injectable poly-L-lactic acid (PLLA-SCA) treatment in correcting cheek wrinkles compared with a no-treatment control. METHODS: Male/female immune-competent adults (aged >21 years) with moderate/severe cheek wrinkles, graded using the Galderma Cheek Wrinkle Scale (GCWS) at rest, were randomized 2:1 to receive PLLA-SCA injections (150 mg; 8 mL reconstitution in sterile water for injection) + 1 mL lidocaine hydrochloride (2%), administered immediately after reconstitution, or no treatment (control). Up to 3 additional treatments were allowed at monthly intervals, and follow-up was at months 7, 9, and 12. The primary endpoint was 1-grade or greater improvement in GCWS at rest for both cheeks at month 12. RESULTS: GCWS at rest responder rate was significantly higher with PLLA-SCA treatment versus the no-treatment control at months 7 (66.2% versus 38.6%; P=0.0043), 9 (70.6% versus 31.1%; P<0.0001), and 12 (71.6% versus 26.1%; P<0.0001). Treating investigators reported improvements in skin radiance (>95%), tighter appearance (>88%), and jawline contour (>85%). PLLA-SCA recipients reported high satisfaction levels regarding improvements in skin radiance (90% or greater), sagging (84% or greater), and firmness (91% or greater) as well as natural-looking results (85% or greater) and a desire for repeat treatment (84% or greater). Treatment-related adverse events were mostly mild in severity with no serious events related to PLLA-SCA injections. CONCLUSION: Injectable PLLA-SCA treatments were well tolerated and significantly reduced the severity of moderate/severe cheek lines and wrinkles, while improving skin quality. Effectiveness was durable over the 12-month study period with high subject-reported satisfaction, natural-looking appearance, and enthusiasm for repeat treatments. CLINICALTRIALS: gov registry number: NCT04124692J Drugs Dermatol. 2024;23(1):1297-1305.        doi:10.36849/JDD.7729.

Cellulite: Current Treatments, New Technology, and Clinical Management.

BACKGROUND: Cellulite is a well-known concern for many women; however, treatment can prove challenging because of the complexities of cellulite etiology, the various factors contributing to its appearance, and the multitude of therapies and procedures available. OBJECTIVE: To discuss current cellulite treatment options and effective clinical management. METHODS: A roundtable meeting was convened to discuss and share views on current cellulite treatment options, new technologies, and clinical management. The participants' views helped guide a narrative review on this topic. RESULTS: Advanced interventions for cellulite treatment-such as physical and acoustic subcision, radiofrequency, and injectable biostimulators-are gradually being established, with accumulating evidence showing efficacy, patient satisfaction, and potentially long-lasting outcomes. Cellulite severity rating scales are necessary for assessing treatment outcomes, but these can be complex to use in clinical practice, and the majority do not include patient or clinician perspectives. CONCLUSION: With the advent of new treatments and technologies, cosmetic surgeons and dermatologists will need to tailor their approach to each patient's needs and manage patient expectations because multimodal methods are likely to be required to address the various factors underlying cellulite appearance.

Cellulite: Clinical Challenges and Future Perspectives.

BACKGROUND: Existing cellulite interventions pose various clinical challenges related mostly to ecchymosis and recovery time. OBJECTIVE: To discuss the current treatment options for minimizing recovery time, efficacy of these options, and investigations into possible future approaches. METHODS: A roundtable meeting was convened to discuss and share views on the clinical challenges seen in the present practice of cellulite treatments along with future approaches and mitigation strategies. The participants' views helped guide a narrative review on this topic. RESULTS: Cosmetic clinicians have a range of new interventions to choose from for cellulite improvement, each with different benefits and safety aspects. Bruising is a typical side effect that is seen with treatments targeting the fibrous septa, such as subcision and injectable treatments, and in some cases may produce long-lasting hyperpigmentation from postinflammatory hyperpigmentation or hemosiderin staining. Various strategies that could potentially mitigate bruising and other adverse effects of cellulite treatment are under clinical investigation, including, but not limited to, different injection techniques and dilutions, compression garments, cold packs, arnica gel, pulsed dye laser treatment, intralesional epinephrine, and tranexamic acid. CONCLUSION: Clinical challenges including varying treatment outcomes and certain treatment sequelae remain, and further research is needed to prevent side effects and improve treatment outcomes.

Update: Cellulite Therapies and Optimizing Treatment Combinations.

Cellulite in the proximal lower extremities is a reported concern among many adult females. The unsightly appearance of cellulite leads many affected individuals to seek treatment by trained specialists. The objective of this review is to provide the reader with an update on new and innovative therapies for cellulite including various treatment combinations to maximize therapeutic outcomes, and strategies for minimizing adverse events. The availability of new technologies and the results from recent clinical trials provide additional tools and data to consider when creating treatment plans for cellulite patients. This update to previous treatment recommendations is based on the most recent developments in cellulite management including the personal experiences of the authors with an emphasis on injectable enzymes, acoustic subcision, targeted verifiable subcision, and biostimulators. Formal clinical studies are warranted to compare various treatment modalities and further investigate combination regimens.

Long-term improvement in the appearance of hypertrophic scars following a single treatment with acoustic subcision-A single center proof-of-concept study.

INTRODUCTION AND OBJECTIVES: Fibrosis, including hypertrophic scar formation, is a pathological condition characterized by excessive production and accumulation of collagen, and loss of tissue architecture, in response to wound healing. Alterations in the extracellular matrix (ECM) biomechanical properties may be important in modulating myofibroblasts and fibrosis formation. The acoustic subcision device uses rapid acoustic pulse technology to noninvasively improve the appearance of hypertrophic scars through both microdisruption of scar tissue matrix and downregulation of fibrotic fibroblasts leading to scar remodeling. The objective of this single-site proof-of-concept IRB-approved human clinical study was to evaluate the efficacy of acoustic subcision device for the improvement in the appearance of hypertrophic scars. METHOD: Eleven hypertrophic scars in 10 participants were treated with a single 6-minute acoustic subcision application without anesthesia. Posttreatment adverse events (AEs) and tolerability were recorded. At 12 and 89 weeks posttreatment, scar heights and volumes were measured, and participant satisfaction questionnaires were completed. Finally, at the last visit the scar appearance was assessed by the Principal Investigator (PI) using the Mecott Modified Scar Scale (MMSS). RESULTS: Immediately following the acoustic subcision treatment, only mild, moderate erythema or pinpoint bleeding were noted. The treatment sessions were considered tolerable by all participants with an average pain score of 2.2 (on a 0-10 pain score with 10 being the worse possible pain). The 12- and 89-week assessments demonstrated mean height reductions of 46.3% and 56.8%, respectively from baseline. The differences in scar height were statistically significant (p < 0.01). The 12- and 89-week assessments demonstrated a mean volume reduction of 63.2% and 58.1% respectively from baseline. The differences in the scar volume were statistically significant (p < 0.001). The PI graded an average improvement of 33.7% in scar appearance using the MMSS, a statistically significant change (p < 0.001). Finally, >90% of participants reported satisfaction with the improvement in their scar. CONCLUSION: This proof-of-concept study showed that a single noninvasive acoustic subcision treatment session can safely provide statistically significant improvement in the appearance of hypertrophic scars with minimal treatment pain and meaningful participant satisfaction. More work is needed on a larger number of scars to verify this finding. Further improvement in appearance is expected with multiple acoustic subcision treatments and/or treatments in combination with currently available options. Additional trials to verify this are planned.

Improvement in the appearance of cellulite and skin laxity resulting from a single treatment with acoustic subcision: Findings from a multicenter pivotal clinical trial.

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.

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

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

A randomized, controlled trial of four ablative fractionated lasers for photoaging: a quadrant study.

BACKGROUND: Fractionated technology has revolutionized laser therapy. With the success of initial devices, several fractionated lasers have appeared on the market. Claims of superiority have made device choice difficult for physicians and patients. MATERIALS AND METHODS: Twelve subjects were treated with fractionated ablative lasers (10,600-nm carbon dioxide and 2790-nm yttrium scandium gallium garnet) in this institutional review board-approved trial. Each face was divided into four quadrants, and each quadrant was randomly treated using one of four lasers. Clinical experience was used to optimize settings. Two patients submitted biopsies from each quadrant immediately after treatment. Patients and blinded investigators assessed pain during treatment and post-treatment improvement in photoaging (measured by rhytides, lentigines, texture, and pore size) using a five-point scale. RESULTS: All devices resulted in statistical improvement in photoaging in all patients, but no device was statistically significantly superior. No statistically significant difference was found in pain scores. All patients reported satisfaction 1 month after treatment. Three patients experienced adverse reactions. Histologically, there were no statistically significant differences between devices. CONCLUSIONS: Fractionated ablative lasers reliably result in improvement in photoaging. Despite marketing claims, no statistically significant differences were found in outcomes, pain during treatment, or histologic findings. Even with experienced users, significant adverse reactions are possible.

Delayed inflammatory reaction to bio-alcamid polyacrylamide gel used for soft-tissue augmentation.

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.