NCT07908953Not yet recruiting
Prospective Evaluation of Recombinant Pbserum Plus® and Pbserum HA 2.0® in Aesthetic and Regenerative Bioremodeling
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
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 31 Aug 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Antony Barbosa Institute
- NCT number
- NCT07908953
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 1 Nov 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Failure to meet the eligibility requirements established for the applicable clinical subprotocol.
Other
- Inability or unwillingness to comply with the study procedures or follow-up schedule.
- Withdrawal of informed consent at any time during the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Antony Barbosa Institute Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.