Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane
|ClinicalTrials.gov Identifier: NCT00931268|
Recruitment Status : Completed
First Posted : July 2, 2009
Results First Posted : December 19, 2013
Last Update Posted : December 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Atrophy||Device: Macrolane VRF 30||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Stabilized Hyaluronic Acid of Non-animal Origin (Macrolane); a Baseline-controlled Single-centre Study.|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||May 2012|
Macrolane VRF 30
Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
Device: Macrolane VRF 30
- Change From 6 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting [ Time Frame: 6 months after treatment compared to baseline ]Pain at sitting was evaluated using a 100 mm VAS with the descriptors 0 = "no pain" to the left and 100 = "worst possible pain" to the right. Pain was assessed by the subject after sitting 15 minutes on a standardized chair. The VAS pain at 6 months was compared to baseline and the change was calculated.
- Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting [ Time Frame: Baseline and up to 18 months after treatment ]Pain at sitting was evaluated using a 100 mm VAS with the descriptors 0 = "no pain" to the left and 100 = "worst possible pain" to the right. Pain was assessed by the subject after sitting 15 minutes on a standardized chair. The change in VAS pain was assessed at the time points 1, 3, 9, 12 and 18 months compared to baseline.
- Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire [ Time Frame: Baseline and at 6 months after treatment ]A physical health summary score and a mental health summary score was generated on a rating scale of 0 to 100 where higher scores indicate better health. The change in health summary scores were assessed at the time points 3, 6, 9, 12 and 18 months compared to baseline.
- Number of Participants With Global Esthetic Improvement [ Time Frame: One month and up to 18 months after treatment ]Number of participants maintaining an improvement compared to baseline using the Global Esthetic Improvement Scale (GEIS) consisting of 5 grades (worse/no change/improved/much improved/very much improved), where the three latter indicates improvement. GEIS was assessed at the time points 1, 3, 6, 9, 12 and 18 months compared to pre-treatment photos.
- Number of Participants With Gel Displacement Evaluated by Magnetic Resonance Imaging (MRI) [ Time Frame: 12 months after treatment ]MRI was performed at baseline and at 1, 6, 9, and 12 months to determine the implant volume, thickness, localization and the possible local displacement of the implant. At the 6, 9 and 12 month visits any displacement was evaluated with MRI by comparison to the 1-month position of the gel. The number of participants with gel displacement are shown below.
- Adverse Event Recording [ Time Frame: Up to 18 months after treatment ]Adverse events (AEs) were collected by open questioning, investigator findings, spontaneous reports and by direct questioning in the Case Report Form (CRF).
- Time Until it Became Impossible to Stay Sitting [ Time Frame: Baseline and at 6 months after treatment ]Evaluation of when (in minutes) it became impossible for the subject to stay in the sitting position on a standardized chair, at the time points 1, 3, 6, 9, 12 and 18 months compared to baseline. In this analysis "more than 60 minutes" was handled as 60 minutes.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00931268
|Henri Mondor Hospital|
|Study Director:||Head of Medical Affairs||Q-Med AB|