An interventional study of Recombinant Hyaluronic Acid (pbserum HA 2.0®) and pbserum Plus® in Skin Laxity, Localized Adiposity and Cellulite, sponsored by Antony Barbosa Institute. Not yet recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Antony Barbosa Institute · Not applicable, Interventional, and Treatment
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.
Introduction
Regenerative aesthetic medicine has evolved toward biologically oriented approaches based on the modulation of the tissue microenvironment and the reorganization of the extracellular matrix. Conditions such as skin laxity, localized adiposity, cellulite, fibrosis, nodules, and scars are associated with complex processes involving pathological fibrotic remodeling, low-grade chronic inflammation, and tissue biomechanical dysfunction. In this context, recombinant enzymes, such as lipase, collagenase, and hyaluronidase, have emerged as promising therapeutic alternatives in aesthetic and regenerative bioremodeling protocols. However, there is still a lack of independent prospective clinical studies systematically evaluating their efficacy, safety, and psychosocial impact across multiple clinical indications.
Objective
To prospectively evaluate the clinical efficacy, safety, and impact on quality of life of the use of recombinant enzymes pbserum Plus® and pbserum HA 2.0® in therapeutic protocols for aesthetic and regenerative bioremodeling in multiple clinical conditions associated with extracellular matrix dysfunction, pathological fibrotic remodeling, and localized adiposity.
Methodology
This is a prospective, longitudinal, multicenter, multi-indication clinical protocol structured as an umbrella study. The study will include 150 adult participants distributed among clinical subprotocols addressing facial and body skin laxity, localized adiposity, submental adiposity, cellulite, fibrosis, nodules, and scars. Participants will be followed for 180 days, with assessments performed at D0, D15, D30, D60, D90, and D180. Clinical, instrumental, and psychometric assessment methods will be used, including standardized photographic documentation, ultrasonography, elastography, cutometry, validated clinical scales, FACE-Q, BODY-Q, GAIS, POSAS, VSS, CSS, and NPS.
Expected Results
The study is expected to demonstrate that protocols based on recombinant enzymes, particularly pbserum Plus®, promote objective clinical improvement in the aesthetic conditions evaluated, with reduction of localized adiposity, improvement of skin laxity, fibrotic reorganization, and scar remodeling, associated with an appropriate safety profile. Positive effects on aesthetic satisfaction, self-image, quality of life, and participants' overall perception of improvement are also expected, contributing to the scientific consolidation of enzyme-based bioremodeling in regenerative aesthetic medicine.
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's planned enrollment of 150 is above the median of 34 across 65 interventional studies indexed under Cellulite.
Browse Cellulite studies →Antony Barbosa Institute is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Ability to understand the study procedures and provide written before enrollment.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive standardized therapeutic protocols based on recombinant enzymes, including recombinant collagenase, recombinant lipase, and recombinant hyaluronidase, using pbserum Plus® and, when applicable, pbserum HA 2.0®, according to the clinical indication and the corresponding study subprotocol. Participants will undergo longitudinal clinical, instrumental, safety, and psychosocial assessments.
Drug: Recombinant Hyaluronic Acid (pbserum HA 2.0®) · Drug: pbserum Plus®
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.
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.
Clinical Safety
Incidence, severity, duration, presumed causality, and clinical management of adverse events and treatment-related complications, including immediate, early, and late adverse events, local or systemic reactions, need for corrective intervention, and treatment discontinuation due to intolerance.
Time frame: From the intervention through Day 180
Change in Skin Elasticity Measured by Cutometry
Change from baseline in skin biomechanical properties at the treated area, assessed by cutometry using standardized acquisition procedures. Cutometry will measure skin deformation and recoil parameters to evaluate changes in skin elasticity and laxity. Values recorded at each follow-up assessment will be compared with the corresponding baseline value.
Time frame: Baseline and Day 180
Change From Baseline in Subcutaneous Fat Thickness Measured by Ultrasonography
Change from baseline in subcutaneous fat thickness at the treated area, measured in millimeters by soft-tissue ultrasonography using a standardized acquisition protocol. The outcome will be calculated as the measurement at Day 180 minus the corresponding baseline measurement. Negative values indicate a reduction in subcutaneous fat thickness.
Time frame: Baseline and Day 90
Change in Treated-Area Volume
Change from baseline in the volume of the treated area, measured in cubic centimeters using Vectra® 3D imaging. The outcome will be calculated as the follow-up volume minus the baseline volume. Negative values indicate a reduction in treated-area volume.
Time frame: Baseline and Day 90
Change From Baseline in Cellulite Severity Scale Score
Change from baseline in cellulite severity assessed using the Cellulite Severity Scale. The total score is calculated from five clinical characteristics: number of depressions, depth of depressions, morphological appearance, skin laxity, and the Nürnberger-Müller classification grade. Higher scores indicate greater cellulite severity.
Time frame: Baseline and Day 180
Plan to share: No
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This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Antony Barbosa Institute