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

What this trial studies

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

Conditions in scope

• Cheek Wrinkles
• Menopausal Women

Interventions

• Sculptra® (Device) — Biostimulator

Who can join

Women only · Ages 22 Years and up

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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2025-08-12
• Primary completion: 2026-11
• Last update posted: 2026-01-15
• First posted: 2026-01-15

Sponsor & contact

Lead sponsor: Galderma R&D (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Protein Expression (12 weeks, 24 weeks, and 36 weeks after Baseline)
  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.

Related ClearedRx care

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