Recruiting

PLLA

Sponsor:

Galderma R&D

Code:

NCT07342400

Conditions

Cheek Wrinkles

Menopausal Women

Eligibility Criteria

Sex: Female

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Sculptra®

Study Details

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

Study ID

NCT07342400

Start date

Aug 12, 2025

Status verified date

Oct, 2025

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 22+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

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

Interventions

Sculptra®

Biostimulator

Primary outcome measure

  • Protein Expression [ Time Frame: 12 weeks, 24 weeks, and 36 weeks after Baseline ]

Central Contacts and Locations

Locations

Miami Dermatology & Laser Institute

Recruiting

Miami, Florida, United States, 33133

Contacts

Peter Illes

305-279-6060PeterI@miamidermlaser.com

Principal Investigator:

Jill Waibel, MD

Day Dermatology & Aesthetics

Recruiting

New York, New York, United States, 10021

Contacts

Caela Startzenbach

212-772-0740caela@drdorisday.com

Principal Investigator:

Doris Day, MD

More Information

Sponsor

Galderma R&D

Last update posted

Jan 15, 2026

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Galderma R&D on 2026-01-15.