Comparing safety and efficacy of acoustic subcision at two different rapid acoustic pulse rates to improve the appearance of cellulite.

BACKGROUND: A recent study showed the safety and efficacy of a noninvasive acoustic subcision device to improve the appearance of cellulite via delivery of rapid acoustic pulses in a single treatment visit. OBJECTIVE: To evaluate and compare the safety and efficacy of a single rapid acoustic pulse treatment visit using an equivalent number of rapid acoustic pulses at a pulse rate of 100 or 50 Hz. METHODS: This single-center, prospective study enrolled 15 adult women with moderate to severe cellulite according to the Cellulite Dimple-At Rest Scale. Each participant would receive nominally 72,000 rapid acoustic pulses at a pulse rate of 50 Hz on the left buttock and thigh, and nominally 72,000 rapid acoustic pulses at a pulse rate of 100 Hz on the right buttock and thigh within one treatment visit. Efficacy was assessed by the ability of blinded, independent reviewers to correctly distinguish the pre- and post-treatment photos, participant satisfaction, and the change in Cellulite Dimple-At Rest scores for each treatment side. Safety was monitored throughout the conduct of the study. RESULTS: For both 100 and 50 Hz pulse rate treated areas, the majority (two out of three) of blinded reviewers correctly identified 100% of the pre/post-treatment photos. For both the 100 and 50 Hz treated areas, 80% of participants agreed/strongly agreed that their cellulite appeared improved at the 12-week follow-up visit. Significant improvements in Cellulite Dimple-At Rest scores were seen for both the 100 and 50 Hz treated areas. All participants thought both the 100 and 50 Hz pulse rate treatments were tolerable, and the pain (mean score ± SD; 2.2 ± 1.2) associated with each was identical. No unexpected or serious adverse events occurred. CONCLUSION: Acoustic subcision delivered via rapid acoustic pulses at 100 Hz, compared to 50 Hz, provides equivalent improvement in the appearance of cellulite while maintaining a similar safety and efficacy profile. For both pulse rates, treatment pain was minimal, and participant satisfaction was high.

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.

Untargeted metabolomics-based molecular networking for chemical characterization of selected Apiaceae fruit extracts in relation to their antioxidant and anti-cellulite potentials.

Stress, obesity, hormonal changes, and aging have been connected to cellulite aggravation resulting in skin dimpled appearance, a very common painless skin disorder with a female preponderance. Several Apiaceae plants have been traditionally used for cosmetic applications. However, their screening for anti-cellulite potential has not been deeply investigated. In this work, UPLC-HRMS/MS coupled with molecular networking was employed to glean a holistic overview of the chemodiversity of the metabolome of nine Apiaceae fruits. Additionally, the extracts were screened for in vitro antioxidant and anti-cellulite activities. Apium graveolens and Petroselinum crispum revealed excellent free radical scavenging activity, remarkably increased lipolysis, and decreased adipogenesis. Furthermore, apigenin and its glycosides were identified to be the major components in both extracts, which might be responsible for the antioxidant activity and anti-cellulite potential. Conclusively, these results signify the potent antioxidant and anti-cellulite properties of A. graveolens and P. crispum fruit extracts, holding potential for the development of plant derived products for cellulite management.

Safety and Efficacy Study of the Application of Redensified Cross-Linked Hyaluronic Acid for Filling Gluteal Volume and Cellulite Depressions.

PURPOSE: To test the efficacy and safety of cross-linked hyaluronic acid application for filling buttocks and cellulite depressions and its permanence over time. METHODS: For a period of a year, 25 patients were applied redensified cross-linked hyaluronic acid in the gluteal area. These patients were all 23-45-year-old women with little fat to be removed. The product used is composed of hyaluronic acid with high cross-linking and redensification which allows it to maintain shape and durability over time. All patients underwent tumescent anesthesia with neuroleptic sedation in the operating room. The procedure was regarded as minimal (container, sterile gloves, and surgical field). The amount applied for gluteal augmentation varied from 50 to 100 ml per application area and according to the patient's needs. For the filling of cellulite depressions, the application was up to 3 cc per depression and up to a total of 40 ml. The maximum volume used per patient in the buttocks did not exceed 200 ml, and it did not exceed 40 ml in cellulite depressions. RESULTS: A group of patients was treated in the upper and middle third of the buttocks in superficial and deep subcutaneous layers and in cellulite depressions. Very good results have been obtained without any major complications. CONCLUSIONS: The use of redensified cross-linked hyaluronic acid of non-animal origin is therefore an option for gluteal augmentation and cellulite depressions. Although the product degrades over time, after 12 months, 44% of treated patients rated their results as highly or very much improved, 36% as improved, 16% rated the improvement as poor, and one patient (4%) was dissatisfied. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Restoration of Aging Body Skin: Evidence-Based Development of a Topical Formulation for Improving Body Skin Quality.

BACKGROUND: Age-related changes in body skin are emerging as important therapeutic targets. A novel topical firming and toning body lotion (FTB) has been developed to target multiple pathways involved in body skin rejuvenation. METHODS: FTB was evaluated in a randomized, double-blind, vehicle-controlled, 12-week study in women (N=54) with mild to moderate lack of firmness on the upper arms and mild to moderate cellulite on the thighs. Investigator clinical assessments, instrumentation evaluations, and patient questionnaires were performed. Histological assessment of ex vivo human skin treated with FTB and gene expression analysis in 3-dimensional human skin models following application of FTB or product comparators were conducted. RESULTS: At week 12, FTB treatment significantly improved (vs baseline) firmness, sagging, smoothness, texture, cellulite, and crepiness on investigator-, instrument-, and photographically assessed outcomes. Participants reported significant improvements in self-perceived efficacy and overall satisfaction with the appearance of their skin following FTB treatment vs vehicle control. Adverse events were mild or moderate in severity. FTB supported new collagen and elastic fiber formation in ex vivo skin. FTB increased skin rejuvenation–associated gene expression vs comparator products. CONCLUSIONS: FTB provided significant improvements in the upper arms and thighs compared with baseline and vehicle control across multiple investigator and instrumentation evaluations. Most participants reported greater efficacy and treatment satisfaction with FTB vs vehicle. FTB treatment stimulated dermal extracellular matrix renewal and induced expression of genes involved in skin rejuvenation pathways. This study provides clinical and preclinical evidence supporting the use of FTB to improve body skin quality. Citation: Makino ET, Jiang LI, Acevedo SF, et al. Restoration of aging body skin: evidence-based development of a topical formulation for improving body skin quality. J Drugs Dermatol. 2023;22(9):887-897. doi:10.36849/JDD.7292.

Use of a microwave device for the treatment of cellulite and localized fat adiposity: a 1-year follow-up study.

BACKGROUND: The body contour market has grown steadily over the last years, due to the persistent demand for non-invasive treatments for localized fat adiposities, cellulite, and skin laxity. MATERIALS AND METHODS: The purpose of this observational study was to evaluate the efficacy and safety of a new device delivering microwaves (MWs) energy for unwanted fat and cellulite reduction after a full cycle of treatments and 1 year later. A total of 45 patients with localized adiposity and/or cellulite in different body areas (inner thigh, upper arm, abdomen, culotte de cheval, buttocks), received four treatment sessions, 4 weeks apart. Photographic records and global aesthetic improvement scale (GAIS) score were performed. RESULTS: For the treatment of cellulite the average GAIS score passed from 3.65 ± 0.49 at 1-month follow-up (1MFU) to 2.7 ± 0.66 at 1-year follow-up (1YFU). For the treatment of localized adiposity, the average GAIS score passed from 3.52 ± 0.51 at 1MFU to 2.82 ± 0.88 at 1YFU. No particular red area was detected either during or after the treatment. There was no mention of assessment of pain or side effects. CONCLUSIONS: The study findings showed that MWs allow for the treatment of cellulite and localized fat adiposity in a safe and effective way, with results lasting over time up to 1 year after the end of the treatment.

Histological aspects of cellulite: shedding light on 100 years of uncertainties.

Cellulite is a common topographic condition of the skin manifested as lumpy, dimpled flesh resembling an orange peel on some zones such as the thighs, hips, buttocks and abdomen. The aetiology of this cosmetic issue is multifactorial, with hormonal, anatomical, environmental and genetic factors influencing its origin, although the exact mechanisms which cause this condition are still unknown. In the present work, a bibliographic analysis of the cellulite etiology has been updated and exposed, as well as the multiple classification grade scales established over the decades. In addition, a new method to classify cellulite severity, in which the clinical manifestations are correlated to the histological aspects more frequently found in the patients, has been presented. Several theories regarding its appearance, structure and clinical aspects have arisen with the aim of developing and establishing a valuable therapeutic approach. However, the lack of a consensus regarding the classification of cellulite severity has complicated the developments within this field.

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.

Analgesic electrical currents associated with carboxytherapy in women with cellulite: A randomized controlled trial.

BACKGROUND: Pain is considered the main limiting factor in carboxytherapy. Electroanalgesia has gained recognition in the field of dermatology and to date, only transcutaneous electrical nerve stimulation (TENS) has proved to be effective at reducing pain associated with carboxytherapy; however, the effect of medium frequency currents has yet to be investigated. AIMS: Compare the effects of TENS, interferential current (IFC), and Aussie current on pain intensity associated with carboxytherapy and sensory comfort in the treatment of cellulite. PATIENTS/METHODS: Seventy-five women aged 18-49 years with moderate and/or severe gluteal cellulite were randomized into three groups: TENS (n = 25), IFC (n = 25), and Aussie current (n = 25), which underwent three sessions of carboxytherapy associated with an electrical current. Current amplitude was adjusted after each puncture, according to the maximum tolerance reported by participants, below the motor threshold. Pain intensity was measured using a numeric rating scale (0-10) and sensory comfort with the visual analogue scale (0-10). RESULTS: There was no significant intergroup difference in pain intensity (p > 0.05) and sensory comfort (p = 0.502) during the application of carboxytherapy throughout the three treatment sessions. CONCLUSION: TENS, IFC, and Aussie currents showed no difference in pain intensity reduction and no current was found to be more comfortable.

Cellulite Pathophysiology and Psychosocial Implications.

BACKGROUND: Cellulite is a highly prevalent aesthetic condition in postpubertal women. OBJECTIVE: The objective of this article was to describe the latest data on the pathophysiology of cellulite and to highlight the psychosocial aspects that should be considered when treating cellulite. METHODS: A roundtable meeting was convened to discuss and share views on the latest data on the pathophysiology and psychosocial aspects of cellulite. The participants' experience helped guide a narrative review on this topic. RESULTS: The pathophysiology of cellulite primarily involves fibrous septal changes. Strategies targeting the fibrous septa have shown the most consistent efficacy, while showing inconsistent or short-term results when targeting the other components of cellulite, such as decreased dermal thickness, vascular alterations, and inflammation. Female sex, increased age, and high body mass index contribute to cellulite pathophysiology. CONCLUSION: Patients seeking treatment for cellulite are willing to endure numerous treatments, high cost, temporary and/or delayed results, and invasive procedures with potential adverse effects. Psychological discomfort has been reported among patients with cellulite, and understanding their behaviors and psychological characteristics can help clinicians provide better care to these patients seeking treatment.

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.

Development of SEDDS formulation containing caffeine for dermal delivery.

OBJECTIVE: The objective of this work was to develop a self-emulsifying drug delivery system (SEDDS) containing caffeine for the treatment of cellulite. METHODS: SEDDS were prepared using the solution method. 0.5% (w/v) caffeine was added to the previously selected excipients. The system was characterized by droplet size, zeta potential, emulsification time and long-term stability. In vitro release and skin permeation were investigated using Franz-type diffusion cells. The cytotoxicity was evaluated on normal human keratinocytes. RESULTS: Caffeine SEDDS were thermodynamically stable, with a zeta potential less than - 22 mV and droplet size around 30 nm, and were long-term stable. The permeation study showed that the formulation promoted caffeine accumulation in the skin layers, suggesting an increase in local circulation. Cytotoxicity studies on HaCaT cells were not conclusive as the surfactant used indicated false-positive results due to its high molar mass. CONCLUSION: It was possible to obtain a stable SEDDS that could cause an increase in blood flow in the applied area, resulting in cellulite reduction.

OBJECTIF: L'objectif de ce travail était de développer un système d'administration de médicaments auto-émulsifiants (SEDDS) contenant de la caféine pour le traitement de la cellulite. MÉTHODES: Les SEDDS ont été préparés par la méthode en solution. 0,5 % (p/v) de caféine a été ajouté aux excipients préalablement sélectionnés. Le système a été caractérisé par la taille des gouttelettes, le potentiel zêta, le temps d'émulsification et la stabilité à long terme. La libération in vitro et la perméation cutanée ont été étudiées dans des cellules de diffusion de type Franz. La cytotoxicité était évaluée sur des kératinocytes humains normaux. RÉSULTATS: Les SEDDS de caféine étaient thermodynamiquement stables, avec un potentiel Zeta inférieur à -22 mV et une taille de gouttelettes d'environ 30 nm, et stables à long terme. L'étude de perméation a montré que les formulations favorisent l'accumulation de caféine dans les couches de la peau, suggérant une augmentation de la circulation locale. Les études de cytotoxicité sur les cellules HaCaT n'ont pas été concluantes car le surfactant utilisé indique des résultats faussement positifs dus à une masse molaire élevée. CONCLUSION: Il a été possible d'obtenir un SEDDS stable qui peut provoquer une augmentation du flux sanguin dans la zone appliquée, entraînant une réduction de la cellulite.

Collagenase Clostridium Histolyticum-aaes Injections for Volumetric Change of Cellulite Dimples and Gluteal Contouring.

BACKGROUND: Collagenase clostridium histolyticum-aaes (CCH) is approved for the treatment of moderate-to-severe cellulite. OBJECTIVE: This is a retrospective image review of subjects previously enrolled in Cohort 2 of the EN3835-305 trial to determine the effects of CCH on volumetric changes of cellulite dimples and overall gluteal contouring. METHODS: In this retrospective analysis, photographs from Day 90 and Day 180 were superimposed on baseline images and the volumetric change of each treated cellulite dimple was quantified. Side-by-side photographs of the buttocks were also evaluated for change in gluteal contour using the Physician Global Aesthetic Improvement Scale (PGAIS). RESULTS: Fifty-eight female subjects and 403 cellulite dimples were evaluated. Three-dimensional imaging analysis revealed a significant improvement in total negative dimple volume at both Day 90 and Day 180 of 27% and 26%, respectively ( p < .001 and p = .002, respectively). At Day 90, the overall gluteal contour, as signified by the mean PGAIS among the 3 blinded dermatologists, was rated as +1 (improved) in 27% ( n = 17) of the subjects. At Day 180, the mean PGAIS was +1 (improved) or +2 (very much improved) in 39% ( n = 26) of the subjects. CONCLUSION: CHH is an effective tool for treating cellulite dimples and improving gluteal contour.