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

Galderma R&D · NCT07342400

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22+ · Women only
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
40
US sites recruiting
2
Study start
August 12, 2025
Record last updated
January 15, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: Sculptra®

Conditions: Cheek Wrinkles; Menopausal Women

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Miami Dermatology & Laser Institute

    Miami, FL 33133

    Site contact: Peter Illes · 305-279-6060 · PeterI@miamidermlaser.com

  • Day Dermatology & Aesthetics

    New York, NY 10021

    Site contact: Caela Startzenbach · 212-772-0740 · caela@drdorisday.com

A Clinical Study to Assess Histological Changes From Treatment of… (NCT07342400) | Bored Studies