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Prospective Evaluation of Recombinant Pbserum Plus® and Pbserum HA 2.0® in Aesthetic and Regenerative Bioremodeling
Sponsor: Antony Barbosa Institute
Summary
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.
Official title: Prospective Clinical Evaluation of the Efficacy and Safety of Recombinant Pbserum Plus® and Pbserum HA 2.0® in Aesthetic and Regenerative Bioremodeling: A Multi-Indication Umbrella Protocol for Skin Laxity, Localized Adiposity, Cellulite, Fibrosis, Nodules, and Scars
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-11-01
Completion Date
2027-07-30
Last Updated
2026-11-02
Healthy Volunteers
No
Interventions
Recombinant Hyaluronic Acid (pbserum HA 2.0®)
High-molecular-weight hyaluronic acid product used as part of the study's aesthetic and regenerative bioremodeling protocols. The intervention will be administered according to the applicable clinical indication and standardized study protocol and evaluated together with the clinical, instrumental, and psychometric outcomes defined for the corresponding subprotocol.
pbserum Plus®
Recombinant enzyme complex containing recombinant collagenase, recombinant lipase, and recombinant hyaluronidase. It will be administered according to the applicable clinical indication and standardized therapeutic protocol for aesthetic and regenerative bioremodeling.
Locations (1)
Antony Barbosa Institute
Belo Horizonte, Minas Gerais, Brazil