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.

Celulitis necrosante estéril en las extremidades de migrantes marinos tras travesías prolongadas / Sterile necrotizing cellulitis in boat immigrants’ limbs after long journeys across the ocean

Fundamento Las Islas Canarias reciben migrantes de origen subsahariano que llegan a la costa tras largas travesías marinas en condiciones adversas. El «pie de patera» es una entidad previamente descrita consistente en un cuadro clínico desarrollado a partir de heridas en los pies que se infectan por estar en contacto con aguas fecales estancadas en el fondo de estas embarcaciones. Describimos un nuevo cuadro clínico, hasta ahora no publicado, consistente en un edema masivo de las extremidades que asocia necrosis de la piel y del tejido celular subcutáneo, respeta el músculo y su etiología no es de origen infeccioso. Material y métodos Diseñamos un estudio descriptivo observacional entre los meses de septiembre del año 2020 y enero del año 2022, ambos incluidos, en el ámbito del hospital de tercer nivel situado en Gran Canaria. Se incluyeron un total de 86 pacientes en una base de datos donde se analizaron 39 variables cualitativas y cuantitativas. Resultados Un total de 16 pacientes desarrollaron el cuadro consistente en una celulitis necrosante estéril. Su fisiopatogenia difiere de la del pie de patera, ya que en todos los casos los cultivos resultan estériles. Conclusiones Como mecanismo responsable, postulamos una teoría inflamatoria derivada del efecto osmótico de la ingesta de agua de mar y/o la reposición agresiva de fluidos a su llegada a los centros hospitalarios donde ingresan con deshidrataciones hipernatrémicas graves. El tratamiento quirúrgico precoz consiste en evacuar el edema mediante incisiones tipo escarotomías, el cual alivia la sintomatología y previene la progresión del cuadro (AU)

Background In the past few years, the Canary Islands received immigrants from sub-Saharan countries that arrive to the coast after long boat trips in extreme adverse conditions. The named «trench foot» is a previously described infectious entity developed after feet wounds that get infected by being in contact with water, urine and excrements in these small and crowded boats. We describe a new clinical entity, not published yet, that consists in massive edema in the extremities associating necrosis of the skin and subcutaneous tissue that characteristically respects the muscle and with a non-infectious etiology. Material and methods A database including 86 patients arrived by boat («patera») from sub-Saharan countries from September 2020 to January 2022 was made and 39 qualitative and quantitative items were analyzed. The Research Unit performed an observational prospective statistical analysis. Results A total of 16 patients developed the entity described as necrotizing cellulitis. Its physiopathology completely differs from the one described in the trench foot, since all the cultures resulted sterile. Conclusions We postulate an inflammatory theory due to the osmotic effect from ingesting sea water and/or the aggressive fluid reposition when they arrive to the emergency room with severe dehydration and hypernatremia. Early surgical evacuation of the edema with escharotomies incisions alleviate the symptoms and prevents progression of the disorder (AU)

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.

A Randomized, Single-Center, Double-Blinded, Split-Body Clinical Trial of Poly- l -Lactic Acid for the Treatment of Cellulite of the Buttocks and Thighs.

BACKGROUND: More than 90% of women report concerns of cellulite on their skin. Poly- l lactic acid (PLLA-SCA) is a biocompatible, semipermanent, synthetic filler that induces neocollagenesis. OBJECTIVE: To investigate the safety and efficacy of PLLA-SCA for the treatment of cellulite of the buttock and thigh regions. METHODS: This was a prospective, single-center, double-blinded, split-body, clinical trial of 20 women with slight to moderate skin laxity of the buttocks and/or thighs contributing to mild-to-moderate cellulite. Each subject's buttocks and thighs were randomized to receive injections with up to 2 vials of PLLA-SCA or the equivalent volume of bacteriostatic water per treatment area. Subjects received at total of 3 treatments 4 weeks apart and were followed for 330 days. RESULTS: Treatment of the buttocks with PLLA-SCA resulted in significant reduction of depression depth, improvement in the morphological appearance of the skin, improvement in the grade of skin laxity, and overall improvement in cellulite appearance. Treated thighs showed reduction in the depth and number of depressions and an improvement in overall cellulite appearance. No significant procedure side effects were found. CONCLUSION: Poly- l lactic acid offers an effective and safe method for treating cellulite of the buttocks and thighs.

Multicenter Pivotal Study Demonstrates Safety and Efficacy of a New Cellulite Procedure: 3-Month Results.

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 < 30 kg/m2 with moderate or severe cellulite on the buttocks and/or thighs were eligible to enroll at 9 sites. Endpoint data included results from 4 of the postprocedural follow-up visits at 24 hours, 7 days, 30 days, and 90 days. The primary endpoints were a mean ≥1 point reduction in the Cellulite Severity Scale at 90 days and no related serious adverse events at 30 days. RESULTS: Seventy-four female participants with a mean BMI of 24.8 ±â€…2.7 and age of 41.4 ±â€…7.4 years received this single procedure. The mean improvement in Cellulite Severity Scale (N = 68) was 1.5 ±â€…0.9 (P < 0.0001). There were no device-related serious adverse events at 30 days. 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.

Multicenter Pivotal Study Demonstrates Safety and Efficacy of a New Cellulite Procedure: Final Results at 12 Months.

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.

Use of Minimally Invasive Radiofrequency-Assisted Lipolysis as a Novel Treatment of Grade 2 and Grade 3 Cellulite.

SUMMARY: Cellulite is a common condition, and laxity in the superficial fascial system contributes significantly to its appearance in the thigh and buttock areas. Components of the superficial fascial system such as the fibrous septae and adipose tissue are targets for an effective treatment to improve the appearance of cellulite. This preliminary report demonstrates the use of radiofrequency-assisted lipolysis as a novel treatment approach to improve the appearance of cellulite by tightening the superficial fascial system. Ten female patients with grade 2 and grade 3 cellulite of the thighs or buttocks were included in this study. Minimally invasive application of bipolar radiofrequency energy to the affected areas was performed. Predetermined internal thermal endpoints at multiple tissue levels and different directions were reached in the treated tissues. Aspiration of the coagulated adipose tissue was performed using a small-diameter cannula to minimize damage to the connective tissues. Pretreatment and 6-month postoperative photographs of 70 different body areas were randomized and scored by five blinded evaluators. Using the Photonumeric Cellulite Severity Scale, scoring of preoperative and postoperative photographs revealed statistically significant differences in all body area comparisons. The magnitudes of the differences in all scored body areas were considered large, and mean differences were all positive, indicating an improvement across time. Grade 2 and grade 3 cellulite of the thighs and buttocks can be effectively treated using radiofrequency-assisted lipolysis technology to decrease the laxity of the superficial fascial system.

Study of a New Controlled Focal Septa Release Cellulite Reduction Method.

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.

The Anatomical Basis of Cellulite Dimple Formation: An Ultrasound-Based Examination.

BACKGROUND: Cellulite is a common aesthetic condition that affects the majority of women. It is characterized by the inhomogeneous appearance of the skin overlying the gluteal and the posterior thigh region. Despite a wide array of treatment options, little has been done to evaluate the anatomical basis of cellulite formation. This study used ultrasound to visualize subcutaneous changes of cellulite to aid with treatment guidance and complication avoidance. METHODS: Cellulite dimples were examined on the bilateral thigh and buttock regions of 50 consecutive women and each dimple was scored with the Hexsel Cellulite Scoring System based on severity. Cellulite dimples were then analyzed by ultrasound to identify the presence, orientation, and origination of subcutaneous fibrous bands and the presence of associated vascular structures. RESULTS: Two hundred total sites were examined, with 173 dimples identified. Of these, 169 demonstrated the presence of fibrous bands (97.6 percent). The majority of bands demonstrated an oblique (versus perpendicular) orientation to the skin (84.4 percent), with the majority (90.2 percent) taking origin from the superficial fascia (versus the deep fascia). Overall, 11 percent of bands had an associated vascular structure. When stratified by body mass index, overweight and obese patients had a higher likelihood of having an associated blood vessel visualized (p = 0.01). Results were similar for dimples in the thigh compared to those located in the buttock region. CONCLUSIONS: Ultrasound appears to be a valid technique to image the subcutaneous architecture of cellulite. This technology can help guide surgeons in real time to improve outcomes and minimize complications while performing cellulite treatments.

Comparison of Cellulite Severity Scales and Imaging Methods.

Cellulite is characterized by dimpled contour alterations of the skin and is present in approximately 85% to 90% of postpubertal females. Although the pathophysiology of cellulite remains to be fully elucidated, experimental evidence indicates a multifactorial process involving the number and types of fibrous septae, microvascular dysfunction, subcutaneous inflammation, decreased dermal thickness with age, and fat deposition. Cellulite is a major cosmetic concern for many women, and a number of both noninvasive (eg, massage, cosmeceuticals, laser therapy) and minimally invasive techniques (eg, subcision, collagenase injection) have been evaluated to improve the appearance of the affected skin. However, evidence for many of these treatments is limited, largely due to the lack of a validated, convenient tool for the standardized evaluation of cellulite severity. Various imaging modalities have been employed to characterize cellulite severity and the impact of treatment, but only 2-dimensional and 3-dimensional digital photography have been adequately validated. However, in many cases, imaging findings do not correlate with subjective measures of cellulite severity. A number of cellulite rating scales have been developed; some provide only a qualitative measure, whereas others do not fully capture all clinically relevant aspects of cellulite, including the perspective of the patient. There remains an unmet need for global adoption of a validated scale that can be utilized easily by clinicians and patients in clinical and research settings. We propose features that should be included in an ideal rating scale for assessment of cellulite severity.

Subcision: Indications, adverse reactions, and pearls.

BACKGROUND: Subcision, also known as subcutaneous incisionless surgery, is a surgical intervention used to treat a variety of skin conditions including atrophic acne scars, depressed scars, cellulite, and wrinkles. AIMS: We plan to prepare a review article about the indications of subcision, its adverse reactions, and pearls. PATIENTS/METHODS: We searched the literature for the information about subcision and its applications from papers published up to March 2019. The search was performed through the databases of the National Library of Medicine. RESULTS: After a thorough review of the published papers about subcision, we finally chose to review 40 articles that had proper sample size and design to prepare this review article. Twenty-one papers were related to the application of subcision in the treatment of acne scar and other scars. Four articles were about the application of subcision to treat cellulite, and eight articles were related to other applications of subcision such as the treatment of striae or nasolabial fold. The remaining seven articles include published review papers about subcision or acne scar classification. CONCLUSION: Subcision seems to be effective on various skin conditions including acne scar, other depressed scars, and cellulite. It is easy to apply and inexpensive with short downtime and no significant complications. Subcision needs proper technique and adequate experience.

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.

A Multicenter, Retrospective Evaluation of Tissue Stabilized-Guided Subcision in the Management of Cellulite.

BACKGROUND: The first FDA-cleared, long-lasting, minimally invasive device for improving the appearance of cellulite was recently launched in Canada as a novel, tissue stabilized-guided subcision (TS-GS) system (Cellfina, Merz North America, Inc., Raleigh, NC). Clinicians from 2 of the first Canadian sites offering this procedure were interested in evaluating treatment efficacy and patient satisfaction after its first year on the market. OBJECTIVES: The authors sought to evaluate the efficacy of TS-GS and the level of patient satisfaction associated with the procedure. METHODS: Medical charts of female patients treated with the TS-GS system in 2017 were retrospectively analyzed at 2 Canadian centers. Measurements at baseline and 3 months posttreatment were assessed for patient satisfaction and physician-rated efficacy. Patient satisfaction was assessed using a 5-point Likert-type scale, and efficacy was evaluated through physician review of 2-deminsional and 3-dimensional photography, the Nürnberger-Müller Scale for cellulite, and the Global Assessment of Improvement Scale. RESULTS: We reviewed 25 patient charts. At month 3, 95.6% of patients were satisfied with treatment results and physician evaluations revealed that on average, patients displayed a 1-point improvement in their cellulite grades. Moreover, Global Assessment of Improvement Scale scores indicated that all patients had visible improvement in the global appearance of cellulite. No serious adverse events were observed within 3 months postprocedure. CONCLUSIONS: The physician ratings, patient satisfaction, and photographic evidence support the efficacy of the TS-GS system to manage grades 1 to 3 cellulite in women's thighs and buttocks. These findings indicate the safety of the TS-GS system.Level of Evidence: 4.

Updates on the understanding and treatment of cellulite.

Cellulite is a common dermatologic condition and frequent cause of cosmetic concern among women. This paper aims to update what is known about the pathogenesis of cellulite and reviews targeted treatment modalities that address its underlying components of microvascular dysfunction, endocrine-mediated inflammation, and connective tissue fibrosclerosis.

Three-Dimensional Analysis of Minimally Invasive Vacuum-Assisted Subcision Treatment of Cellulite.

INTRODUCTION: This was a prospective non-randomized observational study of female subjects seeking treatment for cellulite who were consecutively enrolled into a registry. The objective was to evaluate the efficacy and safety of a tissue stabilized-guided subcision device for the treatment of cellulite using three-dimensional (3D) imaging analysis. METHODS: Subjects received a single treatment to the buttocks and/or posterolateral thighs with the study device. Follow-up telephone evaluations were conducted at 3 and 14 days to evaluate safety and 30 and 90 days to evaluate efficacy. Subjects returned to clinic at three months to obtain follow-up two dimensional and 3D imaging. RESULTS: Sixteen women of average age 44.1 years with a total of 291 lesions of cellulite were treated. Thirteen subjects presented for all follow up visits. Physicians graded results an average of 2.23/5 or "much improved" to "improved" with 9 subjects as much or very much improved (69.2%). Blinded assessors graded overall improvement an average of 2.8 (26-75% improvement) with 8 subjects having greater than 50% improvement overall (61.6%). Improvement in dimple depth was graded an average of 2.9, with 9 subjects having greater than 50% improvement (69.2%). Analysis of 3D imaging yielded 67.4% average improvement in negative volume and 58.4% improvement in minimum height of dimples. Most expected treatment effects resolved within three months after treatment. CONCLUSION: Utilizing three-dimensional imaging analysis, investigators quantitatively and objectively demonstrated efficacy of a tissue stabilized-guided subcision device in the treatment of cellulite of the buttocks and thighs. J Drugs Dermatol. 2018;17(9):960-965.

Cellulite: A Surgical Treatment Approach.

BACKGROUND: Cellulite is one of the most common skin and subcutaneous tissue conditions, affecting predominantly the thighs and hips in postadolescent women. Its etiology is not well defined, and multiple available treatments show variable efficacy. OBJECTIVES: To describe a technique for treatment of cellulite of the gluteal region, thighs, and hips through superficial liposuction utilizing a special cannula, combined with subcutaneous autologous fat grafting. METHODS: A retrospective review was performed of patients treated over 26 years at the Hospital São Lucas, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil. Patients underwent pretreatment evaluation as to the extent of their cellulite, and pretreatment and posttreatment photographs were obtained for visual evaluation of the results. RESULTS: Procedures were performed on 126 patients: 121 (96%) women and 5 (4%) men. The majority considered their results good or excellent. The complication rate was low, with the most common complications being ecchymosis, contour irregularities, partial recurrence of cellulite, seroma, and numbness. CONCLUSIONS: We describe an effective method for the treatment of cellulite. Whereas subcision techniques utilize a needle or microblade to cut fibrous septa, we utilize a special cannula; larger areas can be treated than with subcision. Fat grafting is utilized to correct depressions and improve skin quality, which are added benefits compared to traditional subcision. Considering the multiple available cellulite treatments and their limitations, and the high patient satisfaction rate we achieved, with a low recurrence and complication rate, this technique can be a safe and effective option for patients with cellulite.