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Clinical Trials in the USA / NCT07342400
Recruiting Not applicable

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

NCT07342400 · tracked via the Priya Life Science USA tracker
Sponsor
Galderma R&D
Phase
Not applicable
Started
2025-08-12
Last updated
2026-01-15

Condition(s) studied

Cheek WrinklesMenopausal Women

Investigational drug(s) / intervention(s)

Sculptra®

Sculptra®: Biostimulator

Study 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
FEMALE
Min age
22 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Miami Dermatology & Laser Institute Miami Florida Recruiting
Day Dermatology & Aesthetics New York New York Recruiting

More Galderma R&D trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07342400 on ClinicalTrials.gov ↗ ← All trials in the USA