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NCT Number: NCT06656923

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Lateral Gluteal Depression

Sex eligibility

Female

Study type

Observational

Primary location

Cosmetic Laser Dermatology/West Dermatology Research Center

San Diego, California, 92121, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects who completed all biopsies in the previous SPLASH trial "A Single Center, Double- Blinded, Split-Body, Randomized Clinical Trial of Injectable Poly-L-Lactic Acid for Volumization and Adipogenesis of the Hip Dell - Protocol Number Sculptra-Hip-Dell-2021-12" .

Exclusion criteria

Subjects who had biopsies of poor quality, insufficient tissue, or were otherwise unsuitable for immunofluorescence analysis.

Treatment and study plan

Biopsies

Diagnostic Test

Analyze previous biopsies to quantify changes induced by Poly-L-Lactic Acid in Adipose Tissue

Primary outcomes

Change in cell count per area between PLLA and saline-treated specimens.

Time frame: Specimens are from 6 months post-treatment compared to pre-treatment / Baseline
Analyzing between PLLA and saline-treated specimens for the following populations:
- adipocyte derived stem cells
- proliferating adipocyte-derived stem cells
- preadipocytes/adipocyte precursors
- proliferating preadipocytes/adipocyte precursors
- mature adipocytes and actively differentiating precursors The following proteins will be quantified and the differences between PLLA and saline-treated specimens at 6 months compared to pre-treatment will also be analyzed:
- β-catenin
- PPARγ
- Adiponectin
- Perilipin-1

Sponsors and collaborators

Lead sponsor

Goldman, Butterwick, Fitzpatrick and Groff

Other

Collaborators

Galderma R&D

Registry information

Official study title

PLLA-ADIPOGENESIS-IFA: Immunofluorescence Analysis to Quantify Changes Induced by Poly-L-Lactic Acid in Adipose Tissue

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Oct 24, 2024
Registry last updated: Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.