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.

Real-world effectiveness and safety of collagenase clostridium histolyticum-aaes injections for the treatment of thigh cellulite in women: An open-label study interim analysis.

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.

Infrared thermography as valuable tool for gynoid lipodystrophy (cellulite) diagnosis.

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.

Carboxytherapy in dermatology: A systematic review.

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.

Evaluation of five collagenase clostridium histolyticum-aaes injection techniques for the treatment of cellulite on the buttock or thigh.

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.

Vibration anesthesia during carboxytherapy for cellulite: a study protocol.

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.

Randomized, Double-Blind, Placebo-Controlled Study of Poly-L-Lactic acid for Treatment of Cellulite in the Lower Extremities.

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.

Collagenase Clostridium Histolyticum-aaes for the Treatment of Cellulite in Women: Results From Two Phase 3 Randomized, Placebo-Controlled Trials.

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.

Síndrome larva migrans cutánea en pediatría / Cutaneous Larva Migrans Syndrome in Pediatrics

La dermatosis denominada larva migrans cutánea: (LMC) es una infección cutánea secundaria a infestación parasitaria por la migración de larvas de anquilostomas animales a la epidermis humana, frecuentemente por contacto directo con suelos contaminados, especialmente en zonas tropicales. Se caracteriza por la aparición de lesiones induradas, eritematosas con patrón irregular o serpiginoso acompañado de prurito. Describimos un caso de LMC en una niña, adquirido durante unas vacaciones en Colombia y tratado inicialmente como celulitis con antibióticos (AU)

Cutaneous larva migrans (CLM) is an infection secondary to parasitic infestation due to the migration of animal hookworm larvae into the human skin, frequently by direct contact with contaminated grounds, especially in the tropics. Clinically, it is characterized by the appearance of indurated, erythematous lesions with irregular or "creeping eruption" pattern and pruritus. This article describes a case of CLM infection in a pediatric patient, it was acquired during the holidays in Colombia, diagnosed as cellulitis and treated accordingly with antibiotics without success (AU)

Human Pharmacokinetics and Safety of Subcutaneous Collagenase Clostridium Histolyticum in Women.

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.

Characterization and Pharmacological Evaluation of Anti-Cellulite Herbal Product(s) Encapsulated in 3D-Fabricated Polymeric Microneedles.

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.

Celulitis glútea de repetición en un varón joven / Recurrent Buttock Cellulitis in a Young Man

No disponible

Long-term remission of wells syndrome with omalizumab

No disponible

Collagenase Clostridium Histolyticum for the Treatment of Edematous Fibrosclerotic Panniculopathy (Cellulite): A Randomized Trial.

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.

Actualización en el abordaje y manejo de celulitis / An Update on the Treatment and Management of Cellulitis

La celulitis y la erisipela son infecciones localizadas de partes blandas que se desarrollan como resultado de la entrada de bacterias a través de una barrera cutánea alterada. Es una entidad de presentación relativamente frecuente y su diagnóstico precoz es clave para el tratamiento oportuno del paciente, por lo que debemos estar instruidos en su clínica, diagnóstico y alternativas de tratamiento. En este trabajo, se realiza una revisión de la literatura y actualización en el tema que incluye: manifestaciones clínicas, factores predisponentes, microbiología, diagnóstico, tratamiento y complicaciones. Además, se realiza una revisión de la situación bacteriológica actual en Chile

Cellulitis and erysipelas are local soft tissue infections that occur following the entry of bacteria through a disrupted skin barrier. These infections are relatively common and early diagnosis is essential to treatment success. As dermatologists, we need to be familiar with the clinical presentation, diagnosis, and treatment of these infections. In this article, we provide a review of the literature and update on clinical manifestations, predisposing factors, microbiology, diagnosis, treatment, and complications. We also review the current situation in Chile

Nanoemulsion containing caffeine for cellulite treatment: characterization and in vitro evaluation

The Ginoide Hydrolipodystrophy (GHLD), commonly known as cellulite, occurs in 80-90% of the female population after the puberty period and comes from a metabolic modification in the cutaneous adipose tissue. Caffeine has been used in topical formulations due to its lipolytic action. We studied a nanoemulsion (F3) containing caffeine with two surfactants (oleth-3 and oleth-20) by emulsification method by phase inversion temperature inversion (PIT). The polydispersion indices (PDI) showed the reduced deviation of 0.1. The mean droplet size was ~ 40 nm. The evaluated constant of Ostwald, in the refrigerator condition was the most favorable during the stability test. In the In Raman spectroscopy assay, the caffeine bands found in F3 were compatible with those found in the caffeine solution (1337, 652.5 and 558.2 cm-1). There was no interaction of caffeine anhydrous with other ingredients in nanoemulsion. In the in vitro safety assay the result of 1.4 ranked the F3 as slightly irritating. In the natural membrane, cutaneous permeation test (human skin) permeate concentrations did not exceed the saturation concentration of the PBS buffer (48.96 µg/3 mL). The caffeine solution and F3 permeated statistically equal, but the nanoemulsion visually and sensorially improved the caffeine precipitation.