A Clinical Study to Assess Histological Changes From Treatment of Poly L-lactic Acid Biostimulator on Women at Various Menopausal Stages

A Multi-center, Prospective Clinical Study to Assess Histological Changes From Treatment of Poly L-lactic Acid Biostimulator on Women at Various Menopausal Stages

To assess protein expression stimulated by poly L-lactic acid (PLLA) via punch biopsy at each follow-up visits compared to Baseline.

Study Overview

• Status: Recruiting
• Conditions: Menopausal Women; Cheek Wrinkles
• Intervention / Treatment: Device: Sculptra®

Detailed Description

This is a randomized, prospective study. This study will enroll approximately 40 subjects across two sites. All subjects have moderate-to-severe cheek wrinkles on both cheeks.

Eligible subjects will first receive punch biopsy on one pre-auricular side according to a pre-determined randomization, followed by a first Sculptra treatment on both cheeks starting at the pre-auricular areas first at Baseline visit. Subjects will receive second Sculptra treatment at Week 4, and an optional third treatment at Week 8. At 12 weeks since last Sculptra treatment, half of the subjects will receive a second punch biopsy on the other pre-auricular side (per randomization). Subjects will have a follow up visit at 24 weeks since last Sculptra treatment. At 36 weeks since last Sculptra treatment, the remaining half will receive a second punch biopsy on the other pre-auricular side (per randomization).

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33133
      • Recruiting
      • Miami Dermatology & Laser Institute
      • Principal Investigator: Jill Waibel, MD
      • Contact: Peter Illes; Phone Number: 305-279-6060; Email: PeterI@miamidermlaser.com
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Day Dermatology & Aesthetics
      • Contact: Caela Startzenbach; Phone Number: 212-772-0740; Email: caela@drdorisday.com
      • Principal Investigator: Doris Day, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects diagnosed with symmetrical, moderate-to-severe cheek wrinkles on each side of the face as assessed via the Galderma Cheek Wrinkles Scale.
• Subject with intent to undergo correction of cheek augmentation or contour deficiencies
• Subjects willing to have a 3-mm punch biopsy on each preauricular side
• Subjects willing to maintain the current lifestyle, daily routine (e.g., diet, exercise, sleep, etc.), and a stable Body Mass Index (BMI, ± 5 kg/m2) throughout the study
• Ability of giving consent for participation in the study.
• Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments.

Exclusion Criteria:

• Subjects with asymmetrical severity or unidentical cheek wrinkle score between 2 sides of the cheek.
• Subjects with a history of allergy or hypersensitivity to any ingredient of the treatment products.
• Previous tissue-augmenting therapy, contouring, or revitalization treatment in the face, except lips.
• Previous treatment/procedure in the face in the previous 6 months that, in the Investigator's opinion, would interfere with the study injections and/or study assessments or exposed the study subject to undue risk by study participation, or planning to undergo any of these procedures affecting the treatment area at any time during the study.
• Subjects with any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; All subjects have moderate-to-severe cheek wrinkles and will be treated with Sculptra three times, 4 weeks apart.	Device: Sculptra®; Biostimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein Expression	Punch biopsies will be performed at the pre-auricular areas. Histology staining or immunohistochemistry will be performed on punch biopsy samples to evaluate targeted biomarkers compared to Baseline.	12 weeks, 24 weeks, and 36 weeks after Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject satisfaction using self-assessment questionnaire	Subjects will be asked about their perception and satisfaction with the study treatments using a self-assessment questionnaire at visits after Baseline. The questionnaire will be a 5-point subject satisfaction questionnaire with the following responses: strongly agree, agree, neither agree nor disagree, disagree, strongly disagree.	12 weeks, 24 weeks, and 36 weeks since final Sculptra treatment

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: GLI.04.US.SL.049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes