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

NCT06656923 | Active Not Recruiting

• 1 other identifier: PLLA-HIP-DELL-STAINS-2024
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lateral Gluteal Depression

Outcome Measures

Primary Outcomes (1)

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

  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

  Specimens are from 6 months post-treatment compared to pre-treatment / Baseline

Interventions

Biopsies DIAGNOSTIC_TEST

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

Eligibility Criteria

• Gender Eligibility Details: Previous study was only done on females due to skin quality and aesthetic concerns
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

16 Females that were previously enrolled and biopsied in SPLASH study.

You may qualify if:

• 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" .

You may not qualify if:

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

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead
• Galderma R&D: collaborator

Study Sites (1)

Cosmetic Laser Dermatology/West Dermatology Research Center

San Diego, California, 92121, United States

Location

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 24, 2024
• Study Start: November 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: August 30, 2025
• Last Updated: April 18, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)