CelluliteNCT07908069
Efficacy, Satisfaction, And Safety Of Cellulite Treatment Using Collagen Biostimulators
A study testing Poly-L-Lactic Acid and Calcium Hydroxyapatite in people with Cellulite, run by Antony Barbosa Institute at 1 site in Brazil.
Trial summary
This study will evaluate the efficacy, satisfaction, and safety of two collagen biostimulators used to treat cellulite: poly-L-lactic acid (PLLA) and calcium hydroxyapatite (CaHA). Cellulite is a common aesthetic condition characterized by depressions, irregularities, and nodules on the surface of the skin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cellulite
- What is being tested?
- Poly-L-Lactic Acid and Calcium Hydroxyapatite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age: 18 years or older
- Sex: Female
- Body fat percentage ≤30%
- Grade 2 or 3 cellulite in the buttocks or posterior thigh region, according to the - Cellulite Severity Scale
- No previous cellulite treatment
Who cannot join
- Pregnant or breastfeeding individuals
- No clinical indication for the procedures
- Infection
- Allergy to any component of the materials used
- History of recurrent herpes simplex or keloid formation
- Hematological disorders, including platelet dysfunction, critical thrombocytopenia, hemophilia, or hemodynamic instability
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- Dermatological, systemic, or autoimmune diseases, including chronic diseases and cardiac conditions
- Ongoing cancer treatment
- Use of anticoagulants, steroidal or non-steroidal anti-inflammatory medications
- Use of interfering substances, including alcohol and/or tobacco
- Refusal to participate or failure to sign the informed consent form (ICF)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy, Satisfaction, And Safety Of Cellulite Treatment Using Collagen Biostimulators: A Randomized, Double-Blind Study
This study will evaluate the efficacy, satisfaction, and safety of two collagen biostimulators used to treat cellulite: poly-L-lactic acid (PLLA) and calcium hydroxyapatite (CaHA).
Cellulite is a common aesthetic condition characterized by depressions, irregularities, and nodules on the surface of the skin. The study will include 30 adult women with grade 2 or 3 cellulite affecting the buttocks or posterior thighs.
Read more
The study will use a randomized, double-blind, split-body design. Each participant will receive both treatments, with one side of the body treated with PLLA and the other side treated with CaHA. The side receiving each treatment will be determined randomly.
The severity of cellulite will be assessed using a standardized cellulite severity scale. Treatment efficacy, participant satisfaction, and safety will also be evaluated using the Global Aesthetic Improvement Scale, a Net Promoter Score (NPS), clinical assessments, and photographic documentation.
The study is intended to provide comparative information about the efficacy, satisfaction, and safety of PLLA and CaHA for the treatment of cellulite. The findings may contribute to clinical decision-making regarding the use of collagen biostimulators for this condition.
Read the detailed description
Cellulite, also known as gynoid lipodystrophy or fibroedema geloid, is an aesthetic condition characterized by an irregular and undulated appearance of the skin, commonly affecting the thighs and buttocks. Although it is not considered a disease, cellulite may cause physical discomfort and affect body image and quality of life.
Collagen biostimulators are minimally invasive treatments used to stimulate collagen production and improve tissue structure. Among the products commonly used for aesthetic treatment are poly-L-lactic acid (PLLA) and calcium hydroxyapatite (CaHA). These materials are biocompatible and have been used for their biostimulatory effects, including stimulation of neocollagenesis and improvement of tissue firmness.
The objective of this study is to evaluate and compare the efficacy of PLLA-based and CaHA-based collagen biostimulators for the treatment of cellulite, as well as participant satisfaction and treatment safety.
This is a randomized, double-blind, multicenter, split-body clinical study involving 30 participants. Eligible participants will be women aged 18 years or older, with body fat percentage of 30% or less and grade 2 or 3 cellulite affecting the buttocks or posterior thighs according to the Cellulite Severity Scale proposed by Hexsel, Dal'Forno, and Hexsel.
The split-body design means that each participant will receive both interventions. One side of the body will receive PLLA-based treatment and the other side will receive CaHA-based treatment. The allocation of treatments to the sides of the body will be randomized.
The primary objective is to evaluate the efficacy of the two treatments based on improvement in cellulite severity according to a standardized scale. Secondary objectives are to evaluate participant satisfaction and treatment safety.
Treatment outcomes will be assessed using the Cellulite Severity Scale, the Global Aesthetic Improvement Scale, the Net Promoter Score, clinical assessment, and photographic documentation. Safety will be evaluated through the recording of adverse events associated with the procedures.
Statistical analyses will include descriptive and analytical methods. The Shapiro-Wilk test will be used to assess data normality. Depending on data distribution, paired t-test, independent-samples t-test, Wilcoxon test, or Mann-Whitney U test will be used. Pearson's chi-square test and relative risk calculation will also be used for safety analysis. Statistical significance will be established at p < 0.05.
The study will only begin after approval by the Research Ethics Committee and after participants provide informed consent. The study is expected to contribute comparative evidence regarding the efficacy, satisfaction, and safety of PLLA and CaHA in the treatment of cellulite.
- Conditions
- Cellulite
- Being tested
- Poly-L-Lactic Acid, Calcium Hydroxyapatite
- Keywords
- Collagen Biostimulator, Poly-L-Lactic Acid, Calcium Hydroxyapatite, Global Aesthetic Improvement ScaleGlobal Aesthetic Improvement Scale, Treatment Safety
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly-L-Lactic AcidDrug
Poly-L-lactic acid (PLLA)-based collagen biostimulator administered for the treatment of cellulite.
Calcium HydroxyapatiteDrug
Calcium hydroxyapatite (CaHA)-based collagen biostimulator administered for the treatment of cellulite.
| Study group | Role | What they receive |
|---|---|---|
| Poly-L-Lactic Acid (PLLA) | Experimental | Participants will receive treatment with a poly-L-lactic acid (PLLA)-based collagen biostimulator on one side of the body for the treatment of cellulite. Receives: Drug: Poly-L-Lactic Acid |
| Calcium Hydroxyapatite (CaHA) | Active comparator | Participants will receive treatment with a calcium hydroxyapatite (CaHA)-based collagen biostimulator on the opposite side of the body for the treatment of cellulite. Receives: Drug: Calcium Hydroxyapatite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Cellulite Severity Scale Score at Day 30
Cellulite severity will be assessed using the Cellulite Severity Scale developed by Hexsel, Dal'Forno, and Hexsel. The scale assesses five clinical and morphological characteristics of cellulite, with each item scored from 0 to 3. The total score ranges from 0 to 15, with higher scores indicating greater cellulite severity and therefore a worse outcome. The change will be calculated as the total score at Day 30 minus the total score at baseline. Negative change values indicate a reduction in cellulite severity and therefore a better outcome.
Measured: Baseline (Day 0) and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Jun 2025
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CelluliteStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, split-body clinical study. Each participant will receive both interventions, with one side of the body receiving poly-L-lactic acid (PLLA) and the other side receiving calcium hydroxyapatite (CaHA).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antony Barbosa Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908069
- Sponsor's protocol ID
- 87271425.9.0000.5097
- Status last verified
- Oct 2026
- First submitted
- 18 Aug 2026
- Last updated
- 30 Oct 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Satisfaction, And Safety Of Cellulite Treatment Using Collagen Biostimulators: A Randomized, Double-Blind Study
- ClinicalTrials.gov ID
- NCT07908069
- Acronym / sponsor ID
- 87271425.9.0000.5097
- Conditions
- Cellulite
- Keywords
- Collagen Biostimulator, Poly-L-Lactic Acid, Calcium Hydroxyapatite, Global Aesthetic Improvement ScaleGlobal Aesthetic Improvement Scale, Treatment Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Antony Barbosa InstituteUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 30 Oct 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, satisfaction, and safety of two collagen biostimulators used to treat cellulite: poly-L-lactic acid (PLLA) and calcium hydroxyapatite (CaHA).
Cellulite is a common aesthetic condition characterized by depressions, irregularities, and nodules on the surface of the skin. The study will include 30 adult women with grade 2 or 3 cellulite affecting the buttocks or posterior thighs.
The study will use a randomized, double-blind, split-body design. Each participant will receive both treatments, with one side of the body treated with PLLA and the other side treated with CaHA. The side receiving each treatment will be determined randomly.
The severity of cellulite will be assessed using a standardized cellulite severity scale. Treatment efficacy, participant satisfaction, and safety will also be evaluated using the Global Aesthetic Improvement Scale, a Net Promoter Score (NPS), clinical assessments, and photographic documentation.
The study is intended to provide comparative information about the efficacy, satisfaction, and safety of PLLA and CaHA for the treatment of cellulite. The findings may contribute to clinical decision-making regarding the use of collagen biostimulators for this condition.
Detailed description
Cellulite, also known as gynoid lipodystrophy or fibroedema geloid, is an aesthetic condition characterized by an irregular and undulated appearance of the skin, commonly affecting the thighs and buttocks. Although it is not considered a disease, cellulite may cause physical discomfort and affect body image and quality of life.
Collagen biostimulators are minimally invasive treatments used to stimulate collagen production and improve tissue structure. Among the products commonly used for aesthetic treatment are poly-L-lactic acid (PLLA) and calcium hydroxyapatite (CaHA). These materials are biocompatible and have been used for their biostimulatory effects, including stimulation of neocollagenesis and improvement of tissue firmness.
The objective of this study is to evaluate and compare the efficacy of PLLA-based and CaHA-based collagen biostimulators for the treatment of cellulite, as well as participant satisfaction and treatment safety.
This is a randomized, double-blind, multicenter, split-body clinical study involving 30 participants. Eligible participants will be women aged 18 years or older, with body fat percentage of 30% or less and grade 2 or 3 cellulite affecting the buttocks or posterior thighs according to the Cellulite Severity Scale proposed by Hexsel, Dal'Forno, and Hexsel.
The split-body design means that each participant will receive both interventions. One side of the body will receive PLLA-based treatment and the other side will receive CaHA-based treatment. The allocation of treatments to the sides of the body will be randomized.
The primary objective is to evaluate the efficacy of the two treatments based on improvement in cellulite severity according to a standardized scale. Secondary objectives are to evaluate participant satisfaction and treatment safety.
Treatment outcomes will be assessed using the Cellulite Severity Scale, the Global Aesthetic Improvement Scale, the Net Promoter Score, clinical assessment, and photographic documentation. Safety will be evaluated through the recording of adverse events associated with the procedures.
Statistical analyses will include descriptive and analytical methods. The Shapiro-Wilk test will be used to assess data normality. Depending on data distribution, paired t-test, independent-samples t-test, Wilcoxon test, or Mann-Whitney U test will be used. Pearson's chi-square test and relative risk calculation will also be used for safety analysis. Statistical significance will be established at p < 0.05.
The study will only begin after approval by the Research Ethics Committee and after participants provide informed consent. The study is expected to contribute comparative evidence regarding the efficacy, satisfaction, and safety of PLLA and CaHA in the treatment of cellulite.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, split-body clinical study. Each participant will receive both interventions, with one side of the body receiving poly-L-lactic acid (PLLA) and the other side receiving calcium hydroxyapatite (CaHA).
| Arm | Type | Receives |
|---|---|---|
| Poly-L-Lactic Acid (PLLA) | Experimental | Drug: Poly-L-Lactic AcidParticipants will receive treatment with a poly-L-lactic acid (PLLA)-based collagen biostimulator on one side of the body for the treatment of cellulite. |
| Calcium Hydroxyapatite (CaHA) | Active comparator | Drug: Calcium HydroxyapatiteParticipants will receive treatment with a calcium hydroxyapatite (CaHA)-based collagen biostimulator on the opposite side of the body for the treatment of cellulite. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18 years or older
- Sex: Female
- Body fat percentage ≤30%
- Grade 2 or 3 cellulite in the buttocks or posterior thigh region, according to the - Cellulite Severity Scale
- No previous cellulite treatment
Key exclusion criteria (11 listed)
- Pregnant or breastfeeding individuals
- No clinical indication for the procedures
- Infection
- Allergy to any component of the materials used
- History of recurrent herpes simplex or keloid formation
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 |
|---|---|---|
| Poly-L-Lactic AcidPoly-L-lactic acid (PLLA)-based collagen biostimulator administered for the treatment of cellulite. | Drug | Poly-L-Lactic Acid (PLLA) |
| Calcium HydroxyapatiteCalcium hydroxyapatite (CaHA)-based collagen biostimulator administered for the treatment of cellulite. | Drug | Calcium Hydroxyapatite (CaHA) |
Primary outcome
Change From Baseline in Cellulite Severity Scale Score at Day 30
Time frame: Baseline (Day 0) and Day 30
Cellulite severity will be assessed using the Cellulite Severity Scale developed by Hexsel, Dal'Forno, and Hexsel. The scale assesses five clinical and morphological characteristics of cellulite, with each item scored from 0 to 3. The total score ranges from 0 to 15, with higher scores indicating greater cellulite severity and therefore a worse outcome. The change will be calculated as the total score at Day 30 minus the total score at baseline. Negative change values indicate a reduction in cellulite severity and therefore a better outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Poly-L-Lactic Acid and Calcium Hydroxyapatite in people with Cellulite, 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 11 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: finished, as of the sponsor's last update on 30 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Cellulite Severity Scale Score at Day 30 (time frame: Baseline (Day 0) and Day 30). 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 30 Oct 2026.