ABSTRACT
BACKGROUND: Cellulite is a condition characterized by dimpling and contour irregularities in the gluteal and thigh regions, affecting an estimated 80-98% of postpubertal women. Innovative treatments for cellulite dimpling in the buttocks have gained popularity in recent years, seeking new solutions for a historically challenging condition. In this open-label, investigator-initiated, single-center, prospective clinical study, the authors sought to evaluate the safety and efficacy of diluted calcium hydroxylapatite (CaHA; Radiesse®, Merz Aesthetics, Raleigh, NC) for the treatment of cellulite dimpling in the buttocks of adult women. METHODS: Subjects underwent three treatment sessions, receiving a total of 12 syringes of 1:1 diluted CaHA administered using a cannula-based subcision technique. Endpoints included the cellulite severity scale (CSS), the global aesthetic improvement scale (GAIS), subject satisfaction measured on a 5-point scale, and three-dimensional imaging analysis via the Quantificare 3D Track®. RESULTS: Twenty-four subjects completed the study (mean age, 35 years; mean BMI, 26.88 kg/m2; mean body fat percentage, 31.29%), and no serious complications were reported. Quantitative analysis at week 14 revealed a mean reduction of 54.0% in the number of visible dimples and 50.09% in dimple depth compared to baseline. The mean CSS score decreased by 4.29 points, representing a 43.92% improvement in cellulite severity from baseline (p < 0.0001). Both physician-assessed and subject-assessed GAIS ratings also demonstrated significant improvement, with 91.6% of subjects rating their cellulite appearance as "improved" or greater. CONCLUSION: The results of this study support the safety and efficacy of diluted CaHA for treating cellulite dimpling in adult women. LEVEL OF EVIDENCE II: 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 . CLINICAL TRIALS REGISTRATION: This study is registered with clinicaltrials.gov (ID: NCT05885035) and can be found at this link: https://clinicaltrials.gov/study/NCT05885035 .
Subject(s)
Cellulite , Durapatite , Humans , Female , Cellulite/drug therapy , Adult , Prospective Studies , Durapatite/administration & dosage , Buttocks , Treatment Outcome , Esthetics , Patient Satisfaction/statistics & numerical data , Middle Aged , Cosmetic Techniques , Young Adult , Biocompatible MaterialsABSTRACT
Background and Objectives: Cellulite, or edemato-fibro-sclerotic panniculopathy (EFP), is characterized by dermal and hypodermal changes leading to adipose tissue accumulation and compromised venous circulation. This study investigates the efficacy of a hypertonic cream containing concentrated sodium chloride (Jovita Osmocell®) in addressing water retention and structural alterations in adipose tissue, aiming to interrupt the cellulite formation process. Materials and Methods: A 12-week, prospective, monocentric, double-blind, placebo-controlled study enrolled 30 female subjects with grade II or III cellulite. Patients were randomized to receive hypertonic cream or a placebo. Thigh circumference, ultrasound evaluations, and standardized photographs were collected at baseline, intermediate, and endpoint visits. Adverse events were monitored. Results: After 84 days, the hypertonic cream group exhibited a significant reduction in thigh circumference compared to the placebo group (p = 0.0037). B-mode ultrasound examinations revealed significant changes in the parameters studied, such as the thickness of the subcutaneous tissue. No statistically significant changes were noticed in the placebo group. Volunteers reported the investigational product's pleasantness and good anti-cellulite activity, with no reported adverse events. Conclusions: The hypertonic cream demonstrated efficacy in reducing thigh circumference, addressing water retention and structural alterations in adipose tissue. The proposed mechanism involves osmosis, releasing accumulated fluids between fat cells, supporting drainage, and reducing inflammation. This study supports the efficacy and safety of hypertonic sodium chloride emulsions in cellulite treatment and confirms safety and user satisfaction.
Subject(s)
Cellulite , Humans , Female , Double-Blind Method , Prospective Studies , Cellulite/drug therapy , Adult , Middle Aged , Ultrasonography/methods , Thigh/diagnostic imaging , Treatment Outcome , Skin Cream/therapeutic use , Administration, TopicalABSTRACT
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.
Subject(s)
Cellulite , Cosmetic Techniques , Humans , Female , Cellulite/drug therapy , Cellulite/surgery , Thigh , Buttocks , Prospective Studies , Lactic Acid/adverse effectsABSTRACT
Cellulite is a morphological alteration of the tegument tissue, directly interfering in self-esteem with etiology and pathophysiology far from being a consensus. Although the visual diagnosis of cellulitis is well known, it does not represent the real pathological condition of the subcutaneous tissue. The aim of the study was to investigate the hypothesis that the more heterogeneous tissue pattern analyzed by infrared thermography, the more severe is the cellulite grade. Forty female participants were selected and 60 thighs were analyzed by clinical anamnesis and infrared thermography. Classical visual analysis was correlated to the tissue heterogeneity measured by thermography. R Spearman's correlation between visual evaluation and thermography was 0.92. Phototype presented a negative significant correlation of 0.67 with classical visual analysis. In the present study, we presented a simple method based on infrared thermography that can be adopted in any esthetics office with a correlation of 0.92 with the visual classic evaluation, but, besides, may be very helpful to the clinician to decide which treatment will be adopted, i.e., an aggressive and inflammatory approach such as the radiofrequency of shockwave therapy or an anti-inflammatory approach such as photobiomodulation, depending on the inflammatory status of cellulite.
Subject(s)
Cellulite , Lipodystrophy , Cellulite/drug therapy , Cellulite/therapy , Female , Humans , Lipodystrophy/diagnosis , Lipodystrophy/pathology , Subcutaneous Fat , Thermography , ThighABSTRACT
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.
Subject(s)
Cellulite/drug therapy , Microbial Collagenase/therapeutic use , Antibodies, Neutralizing/blood , Double-Blind Method , Female , Humans , Injection Site Reaction/etiology , Microbial Collagenase/adverse effects , Microbial Collagenase/immunology , Middle Aged , Patient Satisfaction , Treatment OutcomeABSTRACT
BACKGROUND: Poly-l-lactic acid (PLLA) is an injectable volumizer with biostimulatory properties used for volumetric structural rejuvenation in patients with facial fat volume loss but has increasingly been utilized for off-face applications. OBJECTIVE: The objectives of this randomized, double-blind, placebo-controlled single center study was to assess the safety and effectiveness of PLLA for the treatment of lower extremity cellulite in adult women. METHODS: 31 healthy women were enrolled in the study. Eligible subjects received 3 treatments every 4 weeks with either PLLA (treatment group) or saline (control group) injections combined with subcision, into each of the glutes or thighs. Follow-up visits were at 1, 3, and 6 months after treatment. Assessments included live ratings, rating of standardized pictures by a blinded evaluator, patient questionnaires, safety, and tolerability ratings. RESULTS: At the 3 and 6-month follow-up, there was a statistically significant change in the global aesthetic improvement scale (GAIS) compared to baseline as assessed by blinded investigators. Significant improvements were shown in the cellulite severity scale (CSS) as well as in the subject satisfaction questionnaires. Treatments were found to be tolerable, and no severe treatment-related adverse events occurred. CONCLUSION: Repeated PLLA treatments combined with subcision are effective and safe in improving the appearance of cellulite. J Drugs Dermatol. 20(5): doi:10.36849/JDD.5380.
Subject(s)
Cellulite/drug therapy , Cellulose/administration & dosage , Cosmetic Techniques/adverse effects , Lactic Acid/administration & dosage , Mannitol/administration & dosage , Patient Satisfaction , Adult , Cellulite/diagnosis , Cellulite/psychology , Cellulose/adverse effects , Double-Blind Method , Esthetics , Female , Follow-Up Studies , Humans , Injections, Subcutaneous , Lactic Acid/adverse effects , Lower Extremity , Mannitol/adverse effects , Placebos/administration & dosage , Placebos/adverse effects , Severity of Illness Index , Surveys and Questionnaires/statistics & numerical data , Treatment OutcomeABSTRACT
BACKGROUND: Clostridium collagenase histolyticum (CCH) is being evaluated in women as a cellulite treatment. OBJECTIVE: To report preclinical safety and human pharmacokinetics (PK) and safety data for CCH. METHODS: Across 3 PK studies, 41 women received 12 subcutaneous injections per thigh/buttock in 1 session (up to 3.36 mg/dose). Blood samples were taken at baseline; at 5, 10, 20, and 30 minutes postdose; and at 1, 2, 4, 8, 12, 24, 48, 168, and 504 hours postdose. In a preclinical study, rats received 0, 0.029, 0.13, or 0.29 mg/dose of CCH intravenously (IV) every other day (QOD) for 16 days (total, 8 doses) and were evaluated for histopathologic changes. RESULTS: In human PK studies, no quantifiable plasma concentrations of AUX-I or AUX-II were observed postdose (n= 39 evaluable). Adverse events were injection site–related (bruising [97.6%], pain [87.8%], and edema/swelling [46.3%]). Antidrug antibodies were seen in most women at 504 hours postdose. In rats, plasma concentrations of AUX-I and AUX-II (CCH components) were measurable for 30 minutes and 1-2 hours, respectively, after IV administration. At ≥43× proposed human therapeutic dose on a mg/kg basis, rats experienced elevated liver enzyme levels, increased liver weights, and histologic changes that were mostly reversed during a 14-day recovery period. CONCLUSIONS: In human studies, no quantifiable circulating CCH levels were observed after a single subcutaneous dose of CCH up to 3.36 mg. Preclinical data indicated that repeat IV dosing (QOD; 8 doses) at ≥43× proposed human dose on a mg/kg basis for CCH was generally well tolerated.J Drugs Dermatol. 2020;19(9):852-856. doi:10.36849/JDD.2020.5048THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.
Subject(s)
Cellulite/drug therapy , Microbial Collagenase/pharmacokinetics , Adult , Aged , Animals , Buttocks , Cellulite/blood , Dose-Response Relationship, Drug , Drug Evaluation, Preclinical , Embryo, Mammalian/drug effects , Female , Fertility/drug effects , Fetal Development/drug effects , Humans , Injections, Intralesional , Injections, Intravenous , Male , Microbial Collagenase/administration & dosage , Microbial Collagenase/blood , Microbial Collagenase/toxicity , Middle Aged , Rats , Thigh , Toxicity Tests, Subacute , Treatment OutcomeABSTRACT
BACKGROUND: Edematous fibrosclerotic panniculopathy (EFP; cellulite) is associated with thickening and contraction of collagen-rich subdermal septae. Collagenase clostridium histolyticum (CCH) may disrupt collagen-rich septae. OBJECTIVE: To evaluate the safety and efficacy of CCH for treatment of EFP. MATERIALS AND METHODS: In a randomized, double-blind study, women with moderate or severe EFP of the buttocks or posterolateral thighs (i.e., Clinician Reported Photonumeric Cellulite Severity Scale [CR-PCSS] and Patient Reported Photonumeric Cellulite Severity Scale [PR-PCSS] ratings of 3 to 4, and Hexsel Cellulite Severity Scale score ≤13) received up to 3 treatment sessions (Days 1, 22, and 43) of subcutaneous CCH 0.84 mg or placebo injections. End points included the percentage of 2-level and 1-level composite responders (i.e., had ≥2-level or ≥1-level improvement in CR-PCSS and PR-PCSS) at Day 71. RESULTS: Three hundred seventy-five women (mean age, 46.5 years; 86.4% white) were randomly assigned to CCH (n = 189) or placebo (n = 186). At Day 71, the percentages of 2-level and 1-level composite responders were greater with CCH (10.6% and 44.6%, respectively) versus placebo (1.6% and 17.9%; p < .001 for both). The most common adverse events were injection-site related. CONCLUSION: CCH significantly improved EFP appearance versus placebo; further evaluation of CCH for EFP (cellulite) is warranted.
Subject(s)
Cellulite/drug therapy , Microbial Collagenase/therapeutic use , Buttocks , Double-Blind Method , Edema/drug therapy , Female , Humans , Injections, Intralesional , Middle Aged , Severity of Illness Index , ThighABSTRACT
Carbon dioxide is a physiologic compound present in our body, mainly as a result of cellular metabolism. The frequency of carboxytherapy use by dermatologists and cosmetologists increased significantly in the second half of the 20th century due to the fact that it improves blood circulation within skin tissues. This article focuses on the use of carboxytherapy in case of various skin problems, such as stretch marks, scars, loss of elasticity, redundancy of fatty tissue, cellulite, morphea, and alopecia. The review of sparse studies that are available indicate increasing interest in this method.
Subject(s)
Carbon Dioxide/pharmacology , Cellulite/drug therapy , Elasticity/drug effects , Skin Physiological Phenomena/drug effects , Alopecia/drug therapy , Carbon Dioxide/therapeutic use , Cosmetic Techniques , Humans , Striae Distensae/drug therapyABSTRACT
Cellulite is a common topographical alteration where skin acquires an orange peel or mattress appearance with alterations in adipose tissue and microcirculation. This work aims to develop and evaluate a topical niosomal gel formulae with good permeation to reach the subcutaneous fat layer. Several caffeine niosomal dispersions were prepared and incorporated into gel formulae using Carbopol 940 polymer, chemical penetration enhancers, and iontophoresis, then the prepared gels were applied onto the skin of rats and anticellulite activity of caffeine from the prepared gels compared to that of the commercial product Cellu Destock® was evaluated by histological study of the skin and measurement of plasma level of caffeine passing through the skin using liquid chromatography (LC/MS-MS). Results of histology revealed reduction of size and thickness of fatty layer of rat skin in the following order: FVII > FXIV > Cellu Destock® > FVII + Iontophoresis > FXIV + Iontophoresis. Pharmacokinetic results of caffeine in plasma revealed that Cmax, Tmax, and AUC0-12h decreased in the following order: FXIV > FVII > Cellu Destock®. These results conclude that incorporation of caffeine niosomal dispersion into gel matrix with penetration enhancers and iontophoresis resulted in improvement in penetration of caffeine through the skin into the underlying fatty layer in treatment of cellulite.
Subject(s)
Acrylic Resins/metabolism , Adipose Tissue/drug effects , Caffeine/administration & dosage , Cellulite/drug therapy , Gels/chemistry , Iontophoresis/methods , Liposomes/metabolism , Surface-Active Agents/metabolism , Acrylic Resins/chemistry , Acrylic Resins/pharmacology , Administration, Cutaneous , Animals , Caffeine/chemistry , Chemistry, Pharmaceutical , Drug Delivery Systems , Rats , Surface-Active Agents/chemistryABSTRACT
BACKGROUND: Cellulite is one of the worst tolerated aesthetic imperfections. Edema that accompanies cellulite causes disorders of blood flow what may be observed as changes in the skin surface temperature. The aim of this paper was to develop a new method based on the analysis and processing of thermal images of the skin for biometric evaluation of severity of cellulite and monitoring its treatment. METHODS: The observations of the treatment effects were conducted on 10 females (33.4 ± 6.4 years). Thermal images of the volunteers' thighs were captured before starting the therapy (T0 ). In the following stages: T1 , T2 , and T3 , thermal images were captured 2 weeks after the first, second and third Alidya treatment administration, respectively. Profiled algorithms were developed to determine the mean Grey Level Co-occurrence Matrix (GLCM) contrast in the acquired thermograms. RESULTS: The mean GLCM contrast for the phase T0 was 70.91, and for the stages T1 , T2 , and T3 : 57.78, 41.80, and 38.53, respectively. CONCLUSION: The use of proposed method (GLCM contrast) enables biometric evaluation of the effectiveness of cellulite treatment. Traditionally used parameters of infrared analysis such as local points of the maximum and minimum temperature or the median temperatures are not useful in thermal, biometric evaluation of anti-cellulite preparations.
Subject(s)
Biometry/methods , Cellulite/diagnostic imaging , Cellulite/drug therapy , Hypolipidemic Agents/administration & dosage , Skin Temperature/drug effects , Thermography/methods , Adult , Drug Monitoring/methods , Female , Humans , Reproducibility of Results , Sensitivity and Specificity , Treatment OutcomeABSTRACT
Mesotherapy is widely used for its lipolytic effect as an alternative procedure to surgical methods. Although many benefits of lipolytic mesotherapy have been observed, numerous side effects have also been reported. Here, we report a case of cutaneous foreign body granulomas that occurred after lipolytic mesotherapy.
Subject(s)
Granuloma, Foreign-Body/chemically induced , Leg Dermatoses/chemically induced , Mesotherapy/adverse effects , Adult , Cellulite/drug therapy , Drug Therapy, Combination/adverse effects , Female , HumansSubject(s)
Cellulite/drug therapy , Ethylenediamines/adverse effects , Mesotherapy/adverse effects , Mesotherapy/methods , Urticaria/chemically induced , Adipose Tissue/pathology , Betamethasone/therapeutic use , Dermatologic Agents/therapeutic use , Female , Glucocorticoids/therapeutic use , Humans , Middle Aged , Pruritus/chemically induced , Pruritus/drug therapy , Urticaria/drug therapyABSTRACT
BACKGROUND: Cellulite represents a common multi-factorial condition that affects nearly all women and is now recognized as a clinical condition associated with systemic factors and negative psychological effects. Several noninvasive and minimally invasive treatments were developed during the last few years, but limited evidence supports many of them due to lack of evidence, insufficient participants, and potential adverse effects. METHODS: This study aimed to evaluate the efficacy of a seaweed mud application in improving both the structure and function of tissues affected by cellulite. Sixty women with cellulite underwent 4-week applications of seaweed mud on the buttocks and thighs. The following assessments were performed at baseline and after the last treatment: photographic, clinical, and anthropometric evaluation; tests for elasticity and hydration; ultrasonography of cellulite nodules; and cellulite biopsies in the trochanteric region. Patient satisfaction was assessed using a 5-point Likert-scale questionnaire. RESULTS: The treatment resulted in a significant improvement in the severity of cellulite severity between the initial assessment and the 4-week follow-up, with enhanced structure, elasticity, and hydration of the affected tissues. Microscopic analysis of the cellulite biopsies revealed a significant restoration of dermal organization with induced collagen synthesis and reduced inflammation, edema, and lipid deposition following the 4-week seaweed mud applications. Additionally, the treatment led to a remarkable improvement in comfort and satisfaction as well as a reduction in body circumferences. CONCLUSIONS: The cosmetic application of seaweed mud has proven to be a safe, non-invasive treatment for improving the tissue alterations characteristic of cellulite.
Subject(s)
Cellulite , Patient Satisfaction , Seaweed , Thigh , Humans , Female , Pilot Projects , Cellulite/therapy , Cellulite/drug therapy , Adult , Buttocks , Middle Aged , Treatment Outcome , Mud Therapy , Severity of Illness Index , Elasticity/drug effectsABSTRACT
BACKGROUND: Collagenase clostridium histolyticum-aaes (CCH-aaes) is approved in the United States for moderate-to-severe cellulite in the buttocks of adult women. AIM: Interim analysis to evaluate efficacy/safety of CCH-aaes in the treatment of thigh cellulite. METHODS: Data were analyzed from a phase 3, open-label study (REAL). Women with mild-to-moderate cellulite on both thighs (Clinician Reported Photonumeric Cellulite Severity Scale score, 2 or 3) received ≤0.84 mg (volume, 18 ml) of CCH-aaes subcutaneously, in up to 12 dimples per posterolateral thigh, in up to 3 treatment sessions (Days 1, 22, and 43). Follow-up was on Day 90 (interim cutoff). A subset of women participated in the concurrent study (PIXELS), which included high-definition photography and 3D-image scanning of treatment areas. RESULTS: Twenty-two women (44 thighs) were included in the interim analysis (mean age, 42.3 years; thighs with mild cellulite, 68.2%). Investigators reported high percentages of responders (score of "improved" or better on Investigator Global Aesthetic Improvement Scale) at Day 90 for either thigh (86.4%; primary endpoint) or both thighs (72.7%). Patient-reported bother due to cellulite was reduced at Day 90; mean change was 15.3 points (85.5% reduction) in BODY-Q Appraisal of Cellulite Scale total score (possible range, 11-44). In PIXELS analysis, Day 90 3D-image scans showed improvement from baseline in skin roughness in some of the treated thigh areas. The most commonly reported adverse events were injection-site bruising and pain (95.5% and 50.0% of patients, respectively). CONCLUSIONS: CCH-aaes treatment of mild-to-moderate thigh cellulite was effective and generally well tolerated, with markedly reduced cellulite-related bother.
Subject(s)
Cellulite , Cosmetic Techniques , Adult , Humans , Female , Thigh , Cellulite/drug therapy , Microbial Collagenase/adverse effects , Cosmetic Techniques/adverse effects , Cohort Studies , Buttocks , Treatment OutcomeABSTRACT
INTRODUCTION: The overall effects of Carboxytherapy, defined as the administration of carbon dioxide, have been studied for many years. It has been suggested that by improving oxygenation, interacting with the tissue perfusion regulators, and disrupting the adipose cell membranes, the method can lead to notable improvements in different esthetic and pathological conditions. Therefore, we aimed to systematically review the available studies evaluating the potential benefits of carboxytherapy in dermatological conditions and how it objectively stands against scientific scrutiny. METHODS: We searched the PubMed, Scopus, Embase, and Web of Science databases, including the studies exploring the method's efficacy in managing any dermatological condition. RESULTS: A total 27 of studies were identified (with a pooled sample of over 700 cases), most of which were clinical trials. Facial wrinkles, periorbital hyperpigmentation, skin laxity deficiency, scars, striae distensae, localized lipolysis and cellulite, alopecia, chronic diabetic wounds, and psoriatic plaques comprised the package of the dermatological conditions that were studied. Except for a few studies, the method mainly demonstrated significant improvements on all of the mentioned conditions. The inter- and post-operational adverse events were mild and transient, including erythema, pain, crepitus, and ecchymoses. DISCUSSION: Carboxytherapy can provide those practicing in the field with sustainably favorable results. However, the numbers of cases on whom the fat-reducing capabilities of the method were studied and experienced varying degrees of recurrence caught our eye. In addition, we observed a notable disparity between the outcome measures utilized in the studies. The modest sample size in each condition also added to the injury, as the conditions on which the method was evaluated are pretty common in the general population. Therefore, for a definite conclusion, more randomized controlled trials with the shortcomings mentioned well addressed need to be conducted.
Subject(s)
Cellulite , Dermatology , Skin Aging , Striae Distensae , Cellulite/drug therapy , Erythema , Humans , Striae Distensae/drug therapyABSTRACT
Background: To date, there has been no investigation addressing the effects of vibration anesthesia during carboxytherapy. Aim: Investigate the analgesic effect of different vibratory devices during carboxytherapy for the treatment of cellulite. Materials & methods: A total of 78 women between 18 and 49 years of age with cellulite in the gluteal region will be randomly allocated to three groups: Group A (carboxytherapy and vibratory device A), Group B (carboxytherapy and vibratory device B) and control group. Pain intensity will be assessed using a numerical rating scale after each puncture. Expected outcome: Vibration anesthesia is expected to be effective at diminishing the pain intensity caused by carboxytherapy comparison with the control group, with no differences between the vibratory devices. Trial registry: Brazilian Registry of Clinical Trials: ReBEC (RBR-8jcqy7c).
Vibrating anesthesia involves applying vibrations to the skin to reduce discomfort and pain during injections. So far, we do not know much about the therapeutic action of vibrating anesthesia on pain associated with carboxytherapy, a cosmetic treatment that involves injecting carbon dioxide into the fatty layer just beneath the surface of the skin. This article describes a plan to investigate the effect of vibration devices on pain reduction during the application of carboxytherapy in the treatment of cellulite. A total of 78 women between 18 and 49 years old with cellulite in the gluteal region (around the buttocks) will participate in the study and will be divided into three study groups; two groups will receive carboxytherapy with two different vibrating devices, and the third group will receive carboxytherapy without vibrational anesthesia. Pain intensity will be assessed by asking participants to rate their pain using a numerical rating scale after each puncture of carboxytherapy. Vibrational anesthesia is expected to decrease pain caused by carboxytherapy compared with the control group, and it is expected that there will be no differences in pain intensity relief between the two vibrating devices.
Subject(s)
Anesthesia , Cellulite , Buttocks , Cellulite/drug therapy , Female , Humans , Pain Measurement , Vibration/therapeutic useABSTRACT
BACKGROUND: Given differences in buttock versus thigh cellulite, collagenase clostridium histolyticum-aaes (CCH-aaes) injection technique may impact treatment effects at these sites. AIM: To evaluate efficacy and safety of 5 CCH-aaes injection techniques. METHODS: 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. RESULTS: 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. CONCLUSION: Different CCH-aaes injection techniques are required with buttock (Technique A) versus thigh (Technique D) cellulite to optimize treatment outcomes.
Subject(s)
Cellulite , Microbial Collagenase , Buttocks , Cellulite/drug therapy , Female , Humans , Injections, Intralesional , Microbial Collagenase/adverse effects , Thigh , Treatment OutcomeABSTRACT
Skin health is vital for a healthy body. Herbal remedies have long been used for skin care, and their global use has tremendously increased over the past three decades. Although cellulite is seen as a normal condition by the medical community, it is considered a serious cosmetic concern for most affected women. Many topical anti-cellulite creams are available on the market, but unfortunately, their efficacy has not been proven scientifically. Microneedles (MNs) represent a new approach to enhance the permeation of loaded medication through the skin. In this study, the anti-cellulite effects of Vitex agnus-castus and Tamarindus indica extracts were compared using safe and effective polymeric MNs. This delivery system offers a painless alternative to the combined treatment strategy of microneedling devices and anti-cellulite products. The selected standardized extracts were evaluated for their mineral, phenolic and flavonoid contents, which are correlated to a promising antioxidant effect, as demonstrated by an in vitro radical scavenging activity assay. 3D-printing techniques were chosen for fabrication of a micromold, which is inexpensive for mass production. To ensure that MNs were sufficiently strong to perforate the skin without breaking, axial failure force was measured using a micro-mechanical test machine. The anticellulite effects of MNs were assessed using an in vivo diet-induced obesity guinea pig model. Skin properties, histopathology and inflammatory markers were examined. MNs loaded with plant extracts were statistically comparable in normalizing the oxidative state and reducing inflammation, while myeloperoxidase levels were more significantly reduced by T. indica than by V. agnus-castus. This novel delivery system opens the door for new transdermal strategies for cellulite management.