An interventional study of Hyaluronic acid injection (Macrolane VRF30) in Cellulite of the Buttocks, sponsored by Galderma R&D. Completed at 1 site in Brazil. Open to female participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2022-08-26.
Sponsored by Galderma R&D (part of Galderma Group AG) · Not applicable, Interventional, and Treatment
The most common treatments today for enhancing the shape and size of the buttocks are transplantation of the patient's own body fat after liposuction and insertion of permanent implants. Macrolane VRF30 is a gel product based on hyaluronic acid which is a transparent slow-flowing gel. A similar hyaluronic-acid gel from the same manufacturer, Q-Med AB, has been used for many years for the treatment of facial wrinkles. By injecting Macrolane gel into the skin, the shape of the buttocks can be altered and their volume increased.
Aesthetic dermatologists have reported promising results on the use of Macrolane VRF30 for buttocks reshaping and contouring. Although treatment with Macrolane VRF is well documented in breast enhancement, there is limited documentation on the use in buttocks reshaping. Based on these clinical impressions, this study aims at acquiring information on the efficacy and safety of Macrolane VRF30 in this particular indication. As a result of the reshaping of the buttocks, it is expected that improvement of skin laxity will result in contouring and reduction of cellulite. By using standardised evaluation tools, the results of buttock reshaping reported anecdotally can be confirmed by accurate measurements.
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's enrollment of 20 is below the median of 34 across 65 interventional studies indexed under Cellulite.
Browse Cellulite studies →Galderma R&D is the lead sponsor of 284 studies on the registry; 11 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 55 (92%) have results posted.
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Female subjects older than 30 years. 2. Subjects presenting with loss of contour of the upper half of the buttocks, associated with skin laxity and appearance of cellulite grade 1 or 2 on items A, B and D of the CSS.
Exclusion Criteria:
Pregnant women or women intending to get pregnant in the next 12 months. 2. Subjects with known to any compound of the study product or anaesthesia used in the study.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
All subjects will receive hyaluronic acid injection (Macrolane VRF30)
Device: Hyaluronic acid injection (Macrolane VRF30)
Injection of Macrolane subcutaneously in the buttocks area to reduce cellulite
Number of Patients With Aesthetic Improvement of the Buttocks Using Investigator GAIS
Assess the aesthetic improvement of the buttocks after reshaping in female subjects with cellulite associated with laxity and loss of volume of the buttocks at each follow up visit after treatment using the investigator Global Aesthetic Improvement Scale (GAIS).
Time frame: 48 weeks post treatment
Mean Improvement in Cellulite Severity Compared to Baseline Using the Cellulite Severity Scale (CSS)
Assess improvement of cellulite in the buttock areas compared to baseline at each follow up visit after treatment using the Cellulite Severity Scale (CSS). A scale graded 1-15 that measures the severity of cellulites. Grade 1-5 is mild; grade 6-10 is moderate; grade 11-15 is severe.
Time frame: 48 weeks post treatment
Number of CSS Responders
Assess the CSS responder rate, where a responder is defined as a subject who has improved at least one grade from baseline in items A and/or B and/or D of the CSS.
Time frame: 48 weeks post treatment
Number of Subjects With Related Adverse Events
Number of subjects with related adverse events
Time frame: Until 48 weeks post treatment
| Milestone | Macrolane |
|---|---|
| Started | 20 |
| Completed | 19 |
| Not completed | 1 |
Assess the aesthetic improvement of the buttocks after reshaping in female subjects with cellulite associated with laxity and loss of volume of the buttocks at each follow up visit after treatment using the investigator Global Aesthetic Improvement Scale (GAIS).
| Participants | Macrolane |
|---|---|
| Number of Patients With Aesthetic Improvement of the Buttocks Using Investigator GAIS | 7 |
Assess improvement of cellulite in the buttock areas compared to baseline at each follow up visit after treatment using the Cellulite Severity Scale (CSS). A scale graded 1-15 that measures the severity of cellulites. Grade 1-5 is mild; grade 6-10 is moderate; grade 11-15 is severe.
| Units on a scale | Macrolane |
|---|---|
| Mean Improvement in Cellulite Severity Compared to Baseline Using the Cellulite Severity Scale (CSS) | -1 ± 1.6 |
Assess the CSS responder rate, where a responder is defined as a subject who has improved at least one grade from baseline in items A and/or B and/or D of the CSS.
| Participants | Macrolane |
|---|---|
| Number of CSS Responders | 10 |
Number of subjects with related adverse events
| subjects | Macrolane |
|---|---|
| Number of Subjects With Related Adverse Events | 10 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Macrolane | — | 0/20 (0%) | 10/20 (50%) |
| Event | Macrolane |
|---|---|
| injection site painGeneral disorders | 8/20 |
| injection site hematomaGeneral disorders | 2/20 |
| injection site discomfortGeneral disorders | 2/20 |
| injection site puritusGeneral disorders | 1/20 |
| Age, Categorical(Participants) | Macrolane |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 19 |
| >=65 years | 1 |
| Age, Continuous(years) | Macrolane |
|---|---|
| Mean | 48.9 ± 8.2 |
| Sex: Female, Male(Participants) | Macrolane |
|---|---|
| Female | 20 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Macrolane |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 18 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Macrolane |
|---|---|
| Brazil | 20 |
| Cellulite severity scale(units on a scale) | Macrolane |
|---|---|
| Mean | 8 ± 1.7 |
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Apr 2014, a primary completion of Aug 2015 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2020, 5 years 2 months after primary completion.
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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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