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

NCT07342400 | Recruiting FDA Device

• 1 other identifier: GLI.04.US.SL.049
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cheek Wrinkles; Menopausal Women

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Subject satisfaction using self-assessment questionnaire

  12 weeks, 24 weeks, and 36 weeks since final Sculptra treatment

Study Arms (1)

Treatment Group

EXPERIMENTAL

All subjects have moderate-to-severe cheek wrinkles and will be treated with Sculptra three times, 4 weeks apart.

Device: Sculptra®

Interventions

Sculptra® DEVICE

Biostimulator

Treatment Group

Eligibility Criteria

• Age: 22 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (2)

Miami Dermatology & Laser Institute

Miami, Florida, 33133, United States

RECRUITING

Day Dermatology & Aesthetics

New York, New York, 10021, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 15, 2026
• Study Start: August 12, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)