Clinical Research Directory

Prospective Evaluation of Recombinant Pbserum Plus® and Pbserum HA 2.0® in Aesthetic and Regenerative Bioremodeling

This study will evaluate the efficacy and safety of recombinant enzymes contained in pbserum Plus® and pbserum HA 2.0® for aesthetic and regenerative tissue bioremodeling. The study will include adult participants with clinical conditions such as facial or body skin laxity, localized adiposity, cellulite, tissue fibrosis, subcutaneous nodules, and pathological scars. Participants will be evaluated according to the specific clinical condition being treated. The study will assess changes in the treated tissues using clinical evaluations, standardized photographs, patient and evaluator assessments, validated questionnaires, ultrasonography, elastography, cutometry, and three-dimensional imaging when applicable. Participants will be followed longitudinally after treatment, with evaluations at different time points to monitor clinical changes, aesthetic outcomes, satisfaction, and safety. Possible adverse events and treatment-related complications will also be recorded throughout the study. The study aims to determine whether recombinant enzyme-based treatments can provide clinical improvement while maintaining an acceptable safety profile and to generate scientific evidence regarding their use in aesthetic and regenerative medicine.

Efficacy, Satisfaction, And Safety Of Cellulite Treatment Using Collagen Biostimulators

This study will evaluate the efficacy, satisfaction, and safety of two collagen biostimulators used to treat cellulite: poly-L-lactic acid (PLLA) and calcium hydroxyapatite (CaHA). Cellulite is a common aesthetic condition characterized by depressions, irregularities, and nodules on the surface of the skin. The study will include 30 adult women with grade 2 or 3 cellulite affecting the buttocks or posterior thighs. The study will use a randomized, double-blind, split-body design. Each participant will receive both treatments, with one side of the body treated with PLLA and the other side treated with CaHA. The side receiving each treatment will be determined randomly. The severity of cellulite will be assessed using a standardized cellulite severity scale. Treatment efficacy, participant satisfaction, and safety will also be evaluated using the Global Aesthetic Improvement Scale, a Net Promoter Score (NPS), clinical assessments, and photographic documentation. The study is intended to provide comparative information about the efficacy, satisfaction, and safety of PLLA and CaHA for the treatment of cellulite. The findings may contribute to clinical decision-making regarding the use of collagen biostimulators for this condition.

A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With EFP; Cellulite (Stage 1)

The Stage 1 of this phase 2 study is an open-label single ascending dose (SAD) study to assess the efficacy and safety of CBL-514 in participants with Edematous Fibrosclerotic Panniculopathy (EFP) cellulite.

A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With EFP; Cellulite (Stage 2)

The Stage 2 of this phase 2 study is an open-label, single-arm study to assess the efficacy and safety of CBL-514 in participants with Edematous Fibrosclerotic Panniculopathy (EFP) cellulite.

Cyrolipolysis vs Cyrolipolysis and Subcision for Cellulite

This is a prospective randomized controlled study comparing the efficacy of cryolipolysis versus a combination of cryolipolysis and surgical subcision for the treatment of cellulite. The treatment sites are both outer thighs. One outer thigh will be randomized to receive one treatment of cryolipolysis, while the contralateral thigh will be assigned to receive the combination cryolipolysis plus surgical subcision. A live rating by a blinded dermatologist will evaluate the treatment and control areas using a cellulite severity scale at week 0 (before treatment) and at the 3-month follow up visit.

Quantitative Assessment of the Efficacy of Alidya

This study evaluated the efficacy of ALIDYA, a Class III medical device used in needle mesotherapy, for the treatment of cellulite (gynoid lipodystrophy) in women. Thirty female volunteers aged 20-45 years with cellulite graded 1 to 4 on the Nürnberger-Müller scale received a series of six mesotherapy treatments administered weekly to the posterior thighs. The study aimed to determine whether this treatment could improve the clinical appearance of cellulite and produce measurable changes in skin structure, microcirculation, and tissue composition. Assessments were performed before treatment, one month after the first application, and three months after the first application, using expert clinical grading as well as several objective instrumental methods: standardized clinical photography with texture analysis, thermal imaging, hyperspectral imaging, three-dimensional skin surface analysis (Antera 3D), and high-frequency ultrasound. The hypothesis was that ALIDYA would reduce the severity of cellulite by improving skin surface topography, microcirculation, and the structural quality of the skin.

To Assess the Effectiveness of Multiple Dose, Multiple Concentrations of Qwo, for the Treatment of Mild to Moderate Cellulite.

This is a single center, off-label, multiple dose, multiple injection areas, Phase 4 study to assess the safety and efficacy of multi-dilution CCH in adult women with mild or moderate edematous fibrosclerotic panniculopathy (EFP). 5 subjects will be screened and dosed in the buttock and thigh areas using a multi-dilution injection technique. Qualified subjects (determined by investigator assessment) will receive a single vial of 0.84 mg of CCH to treatment areas (buttocks and thighs) for a total dose of 1.68 mg in both buttocks and both thighs per treatment session × 3 treatment sessions (Day 1, Day 22, and Day 43). Subjects will have follow-up visits at approximately 90 after Day 1.

Minimally Invasive Active Release of Septa Bands for Cellulite and Connective Tissue Release for Fibrosis Treatment in Body Contouring Surgery

This prospective study aims to evaluate the safety and effectiveness of AVELI for reducing cellulite and fibrotic tissue in patients undergoing High-Definition Liposculpture, exploring if AVELI improves the aesthetic outcomes, and reduced the clinically evident cellulite and/or fibrosis. The main questions this study seeks to answer are: * Does AVELI safely reduce cellulite and fibrotic tissue without causing serious adverse events? * How effective is AVELI in improving patient-reported outcomes and aesthetic appearance? Through this study, the study team aims to evaluate the safety and effectiveness of AVELI. The study procedures include: * Baseline data collection of sociodemographic variables. Data collection of surgical variables, adverse events, and satisfaction scores. * All patients will undergo the standardized High-Definition Liposculpture technique, with AVELI applied to all identified cellulite and/or fibrosis release. * Photographic and 3D imaging preoperatively and at follow-ups (1, 3, 6, and 9 months).