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NCT07908953
Prospective Evaluation of Recombinant Pbserum Plus® and Pbserum HA 2.0® in Aesthetic and Regenerative Bioremodeling
Conditions: Skin Laxity, Localized Adiposity, Cellulite, Tissue Fibrosis, Pathological Scarring
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: Antony Barbosa Institute
Location: Antony Barbosa Institute Belo Horizonte Minas Gerais
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.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18 years or older.
* Clinical indication compatible with one of the study subprotocols: facial skin laxity, body skin laxity, submental adiposity, localized body adiposity, cellulite, tissue fibrosis, subcutaneous nodules, or pathological scars.
* Clinical condition suitable for the proposed minimally invasive therapeutic approach.
* Ability and willingness to comply with the study procedures and scheduled follow-up assessments.
Ability to understand the study procedures and provide written informed consent before enrollment.
Exclusion Criteria:
* Clinical conditions incompatible with the proposed intervention.
* Contraindications or relevant hypersensitivity to the study products or their components.
* Relevant clinical conditions that may compromise participant safety or interfere with study assessments.
* Inability or unwillingness to comply with the study procedures or follow-up schedule.
* Failure to meet the eligibility requirements established for the applicable clinical subprotocol.
* Withdrawal of informed consent at any time during the study.
Source: ClinicalTrials.gov (NCT07908953). StuddyBuddy aggregates publicly available trial information.