A Phase 4 interventional study of Macrolane VRF30 in Volume Restoration and Shaping of the Buttocks, sponsored by Galderma R&D. Completed at 4 sites in 3 countries. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-28.
Sponsored by Galderma R&D · Phase 4, Interventional, and Other
The purpose of the study is to evaluate the efficacy and safety of Macrolane for volume restoration and shaping of the buttocks.
Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.
Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Injection of Macrolane VRF30 in buttocks
Device: Macrolane VRF30
Injection of Macrolane VRF30 in buttocks. The sum of injected volume of Macrolane VRF30 at initial treatment and touch-up must not exceed 400 ml per Subject
Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 6
To evaluate the perceived improvement at 6 months compared to baseline as judged by the Subject using Global Esthetic Improvement Scale (GEIS). Percentage of subjects with improved, much improved or very much improved on GEIS, subject's evaluation.
Time frame: 6 Months
Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 1
To evaluate the perceived improvement at 1 month compared to baseline as judged by the Subject using GEIS. Percentage of subjects with improved, much improved or very much improved on GEIS, subject's evaluation.
Time frame: 1 Month
Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 12
To Evaluate the Perceived Improvement at 12 Months Compared to Baseline as Judged by the Subject Using GEIS. Percentage of subjects with Improved, Much Improved or Very Much Improved on GEIS, Subject's evaluation.
Time frame: 12 Months
| Milestone | Macrolane VRF30 |
|---|---|
| Started | 61 |
| Completed | 50 |
| Not completed | 11 |
To evaluate the perceived improvement at 6 months compared to baseline as judged by the Subject using Global Esthetic Improvement Scale (GEIS). Percentage of subjects with improved, much improved or very much improved on GEIS, subject's evaluation.
| percentage of participants | Macrolane VRF30 |
|---|---|
| Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 6 | 80.4 (67.6 to 89.8) |
To evaluate the perceived improvement at 1 month compared to baseline as judged by the Subject using GEIS. Percentage of subjects with improved, much improved or very much improved on GEIS, subject's evaluation.
| percentage of participants | Macrolane VRF30 |
|---|---|
| Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 1 | 91.2 (80.7 to 97.1) |
To Evaluate the Perceived Improvement at 12 Months Compared to Baseline as Judged by the Subject Using GEIS. Percentage of subjects with Improved, Much Improved or Very Much Improved on GEIS, Subject's evaluation.
| percentage of participants | Macrolane VRF30 |
|---|---|
| Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 12 | 68.0 (53.3 to 80.5) |
Collected over From treatment up to 24 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Macrolane VRF30 | — | 2/61 (3.3%) | 13/61 (21.3%) |
| Event | Macrolane VRF30 |
|---|---|
| LipectomySurgical and medical procedures | 1/61 |
| Ectopic pregnancyPregnancy, puerperium and perinatal conditions | 1/61 |
| Event | Macrolane VRF30 |
|---|---|
| Implant Site SwellingGeneral disorders | 6/61 |
| Injection Site PainGeneral disorders | 4/61 |
| Implant Site PruritusGeneral disorders | 4/61 |
| Implant Site PainGeneral disorders | 4/61 |
| Implant Site HaematomaGeneral disorders | 4/61 |
Intention To Treat
| Age, Continuous(years) | Macrolane VRF30 |
|---|---|
| Mean | 41.3 (20.1 to 64.5) |
| Sex: Female, Male(Participants) | Macrolane VRF30 |
|---|---|
| Female | 57 |
| Male | 4 |
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Galderma R&D