An interventional study of Poly-L-Lactic Acid and Calcium Hydroxyapatite in Cellulite, sponsored by Antony Barbosa Institute. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Antony Barbosa Institute · Not applicable, Interventional, and Treatment
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.
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.
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's enrollment of 30 is below 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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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.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Drug: Poly-L-Lactic Acid
Participants will receive treatment with a calcium hydroxyapatite (CaHA)-based collagen biostimulator on the opposite side of the body for the treatment of cellulite.
Drug: Calcium Hydroxyapatite
Poly-L-lactic acid (PLLA)-based collagen biostimulator administered for the treatment of cellulite.
Calcium hydroxyapatite (CaHA)-based collagen biostimulator administered for the treatment of cellulite.
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.
Time frame: Baseline (Day 0) and Day 30
Plan to share: No
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Studies of the drug tested here: poly(lactide)
Antony Barbosa Institute