At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 61 enrolled
Drug / intervention
Macrolane VRF30device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open, Post-marketing, Multi-center Study to Evaluate Efficacy and Safety of Macrolane VRF30 for Volume Restoration and Contouring of the Buttocks
In Brief
A Phase 4 clinical trial evaluating Macrolane VRF30 for Volume Restoration and Shaping of the Buttocks. Completed, enrolled 61 participants across 4 sites in 3 countries.
Detailed Summary
The purpose of the study is to evaluate the efficacy and safety of Macrolane for volume restoration and shaping of the buttocks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Spain, Sweden
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2008
Primary CompletionOct 2009
First PostedApr 2011
Study CompletionMay 2011
TodayJul 2026
First PostedApr 8, 2011
Enrollment StartSep 1, 2008
Primary CompletionOct 1, 2009
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.2 years ago
Interventions
Macrolane VRF30device
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