Cellulite of the Buttocks
Conditions
Keywords
cellulite
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHyaluronic acid injection (Macrolane VRF30)
Injection of Macrolane subcutaneously in the buttocks area to reduce cellulite
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. 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. 3\. Treatment-naïve subjects for fillers in the areas to be treated. 4. Subjects with signed informed consent. 5. Medical history and physical examination which, based on the investigator's opinion, do not prevent the subject from taking part in the study and use the product under investigation. 6\. Subjects should maintain their habits regarding physical activity. 7. Availability of the subject throughout the duration of the study.
Exclusion criteria
* 1\. Pregnant women or women intending to get pregnant in the next 12 months. 2. Subjects with known hypersensitivity to any compound of the study product or anaesthesia used in the study. 3\. Subjects with history of any other adverse effect, which should prevent the subject from participating in the study according to the investigator's opinion. 4\. Subjects participating in other clinical trials within 30 days prior to baseline. 5\. Any prior surgery, any prior cosmetic procedures or side effects from previous procedures in the buttocks, including permanent fillers, liposuction and prosthesis, that may interfere with the results. 6\. Subjects with presence of autoimmune disease or other chronic disease that in the opinion of the Investigator may interfere with the outcome of the study. 7\. Subjects on immunomodulatory therapy (suppressive or stimulatory). 8. Subjects with active inflammation or infection in the areas to be treated. 9. Subject with bleeding disorders or subjects who are taking thrombolytics or anticoagulants. 10\. Subjects who have taken inhibitors of platelet aggregation, including nonsteroidal anti-inflammatory agents and acetylsalicylic acid, 2 weeks before treatment. 11\. Subjects with contraindications for MRI, such as presence of pacemaker, clips or splinter, metal prosthesis or tendency for claustrophobia. 12\. Subjects who are study site staff for this study, or close relatives of the study site staff, as well as subjects who are employed by the Sponsor company, or close relatives of employees at the Sponsor company.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Aesthetic Improvement of the Buttocks Using Investigator GAIS | 48 weeks post treatment | 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). |
| Mean Improvement in Cellulite Severity Compared to Baseline Using the Cellulite Severity Scale (CSS) | 48 weeks post treatment | 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. |
| Number of CSS Responders | 48 weeks post treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Related Adverse Events | Until 48 weeks post treatment | Number of subjects with related adverse events |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Macrolane Att subjects will be treated with Macrolane
Hyaluronic acid injection (Macrolane VRF30): Injection of Macrolane subcutaneously in the buttocks area to reduce cellulite | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Macrolane |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 48.9 years STANDARD_DEVIATION 8.2 |
| Cellulite severity scale | 8 units on a scale STANDARD_DEVIATION 1.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Brazil | 20 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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
Population: Improvement in cellulite at 48 weeks compared to baseline, using the CSS and indicated by the grading reduction.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Macrolane | Mean Improvement in Cellulite Severity Compared to Baseline Using the Cellulite Severity Scale (CSS) | -1 Units on a scale | Standard Deviation 1.6 |
Primary
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
Population: Number of subjects who were improved at least 1 grade from baseline in items A and/or B and /or D of the CSS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Macrolane | Number of CSS Responders | 10 Participants |
Primary
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
Population: Global aesthetic improvement was assessed as Very much improved, Much improved, Improved, No change or Worse. Number of improved subjects (i.e. very much improved, much improved or improved) was presented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Macrolane | Number of Patients With Aesthetic Improvement of the Buttocks Using Investigator GAIS | 7 Participants |
Secondary
Number of Subjects With Related Adverse Events
Number of subjects with related adverse events
Time frame: Until 48 weeks post treatment
Population: Evaluation of safety by assessment of number of related adverse events (AEs)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Macrolane | Number of Subjects With Related Adverse Events | 10 subjects |