RecruitingNot ApplicableNCT07342400

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

Sponsor

Galderma R&D

Enrollment

40 participants

Start Date

Aug 12, 2025

Study Type

INTERVENTIONAL

Conditions

Menopausal Women Cheek Wrinkles

Summary

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

Eligibility

Sex: FEMALEMin Age: 22 Years

Inclusion Criteria6

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 Criteria5

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.

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