Trials / Active Not Recruiting
Active Not RecruitingNCT06656923
Analyze Previously Collected Biopsy Samples From Participants Who Completed the "SPLASH: Split-Body Randomized Clinical Trial of Poly-L-Lactic Acid for Adipogenesis and Volumization of the Hip Dell" Study
PLLA-ADIPOGENESIS-IFA: Immunofluorescence Analysis to Quantify Changes Induced by Poly-L-Lactic Acid in Adipose Tissue
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 14 (actual)
- Sponsor
- Goldman, Butterwick, Fitzpatrick and Groff · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Accepted
Summary
Primary Objective: use immunofluorescence (IF) on previously obtained biopsies to analyze and quantify changes in adipose tissue of subjects injected with poly-L-lactic acid (PLLA) or saline.
Detailed description
Sixteen female adults that participated in SPLASH study will be enrolled in this retrospective study. It aims to analyze previously collected biopsy samples from participants who completed the "SPLASH: Split-Body Randomized Clinical Trial of Poly-L-Lactic Acid for Adipogenesis and Volumization of the Hip Dell" study. The study will use immunohistology to assess changes in adipose tissue associated with treatment with PLLA (poly-L-lactic acid). We hypothesize that specimens treated with PLLA will be found to have more adipocyte-derived stem cells and preadipocytes undergoing mitosis and differentiation compared to control specimens.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Biopsies | Analyze previous biopsies to quantify changes induced by Poly-L-Lactic Acid in Adipose Tissue |
Timeline
- Start date
- 2024-11-01
- Primary completion
- 2025-02-28
- Completion
- 2025-08-30
- First posted
- 2024-10-24
- Last updated
- 2025-04-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06656923. Inclusion in this directory is not an endorsement.