Skin LaxityNCT07908953
Prospective Evaluation of Recombinant Pbserum Plus® and Pbserum HA 2.0® in Aesthetic and Regenerative Bioremodeling
A study testing Recombinant Hyaluronic Acid (pbserum HA 2.0®) and pbserum Plus® in people with Skin Laxity and Localized Adiposity, run by Antony Barbosa Institute at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Laxity, Localized Adiposity, Cellulite
- What is being tested?
- Recombinant Hyaluronic Acid (pbserum HA 2.0®) and pbserum Plus®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Antony Barbosa Institute
Belo Horizonte, Minas Gerais, 30575-210
Antony P Barbosa, +55 31 991552065, drantonybarbosa@gmail.com
About this study
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
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Recombinant Hyaluronic Acid (pbserum HA 2.0®), pbserum Plus®
- Keywords
- Enzymatic bioremodeling, recombinant enzymes, regenerative aesthetic medicine, extracellular matrix
- Medical subject headings
- Cutis Laxa, Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Hyaluronic Acid (pbserum HA 2.0®)Drug
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®Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Enzyme Treatment | Experimental | 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. Receives: Drug: Recombinant Hyaluronic Acid (pbserum HA 2.0®); Drug: pbserum Plus® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, longitudinal, multicenter, pragmatic, open-label, single-group interventional study conducted under an umbrella protocol. Participants will receive standardized therapeutic protocols involving pbserum Plus® recombinant enzyme-based interventions according to their clinical condition and treatment indication. Clinical efficacy, safety, and psychosocial outcomes will be assessed longitudinally.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antony Barbosa Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908953
- Sponsor's protocol ID
- IAB.PBSERUM.082026
- Status last verified
- Oct 2026
- First submitted
- 31 Aug 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07908953
- Acronym / sponsor ID
- IAB.PBSERUM.082026
- Keywords
- Enzymatic bioremodeling, recombinant enzymes, regenerative aesthetic medicine, extracellular matrix
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Antony Barbosa InstituteUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, longitudinal, multicenter, pragmatic, open-label, single-group interventional study conducted under an umbrella protocol. Participants will receive standardized therapeutic protocols involving pbserum Plus® recombinant enzyme-based interventions according to their clinical condition and treatment indication. Clinical efficacy, safety, and psychosocial outcomes will be assessed longitudinally.
| Arm | Type | Receives |
|---|---|---|
| Recombinant Enzyme Treatment | Experimental | Drug: Recombinant Hyaluronic Acid (pbserum HA 2.0®), Drug: pbserum Plus®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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Recombinant Enzyme Treatment |
| 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. | Drug | Recombinant Enzyme Treatment |
Primary outcome
Clinical Safety
Time frame: From the intervention through Day 180
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.
Change in Skin Elasticity Measured by Cutometry
Time frame: Baseline and Day 180
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.
Change From Baseline in Subcutaneous Fat Thickness Measured by Ultrasonography
Time frame: Baseline and Day 90
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.
Change in Treated-Area Volume
Time frame: Baseline and Day 90
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.
Change From Baseline in Cellulite Severity Scale Score
Time frame: Baseline and Day 180
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Skin Laxity
Active, not recruiting
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
Wrinkle, Lax Skin
Active, not recruiting
Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
Skin Laxity, Wrinkle
Active, not recruiting
Safety and Efficacy of Matrix Pro for Eyebrow Lift and Lift of Submental/Neck Laxity
Laxity; Skin
Active, not recruiting
Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment
Skin Laxity, Wrinkle
Recruiting
VISION Study: Visualization-Guided SMAS Treatment to Optimize Nonsurgical Lifting
Facial Skin Laxity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recombinant Hyaluronic Acid (pbserum HA 2.0®) and pbserum Plus® in people with Skin Laxity and Localized Adiposity, run by Antony Barbosa Institute at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Safety (time frame: From the intervention through Day 180). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.