PLLA (Sculptra) effects on cheek skin across menopausal stages

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, prospective trial will enroll about 40 women with symmetrical moderate-to-severe cheek wrinkles at two U.S. dermatology sites. Participants receive a baseline 3-mm punch biopsy on one preauricular side, then Sculptra injections to both cheeks at baseline and week 4 with an optional third treatment at week 8. According to randomization, the opposite-side biopsy is taken either 12 or 36 weeks after the last Sculptra treatment, and protein expression will be compared to baseline. The study links histological changes to treatment timing and menopausal stage while tracking clinical appearance and safety.

Why it matters

Who can join: the full rules

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.

Where it's running

• Miami Dermatology & Laser Institute
  Miami, Florida, United States Recruiting
• Day Dermatology & Aesthetics
  New York, New York, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.