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

Part of paid clinical trials in Miami, Florida.

Sponsor
Galderma R&D
Study ID
NCT07342400
Status
Recruiting
Apply to this trial

Conditions

  • Cheek Wrinkles
  • Menopausal Women

Eligibility Criteria

Sex
FEMALE
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sculptra® — DEVICE
    Biostimulator

Study Details

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

Key Dates

Start date
Aug 12, 2025
Status verified
Oct 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

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

Locations (2)

FacilityCityStateZIPSite coordinators
Miami Dermatology & Laser InstituteMiamiFlorida33133
Peter Illes
[email protected]
305-279-6060
Jill Waibel, MD (PRINCIPAL_INVESTIGATOR)
Day Dermatology & AestheticsNew YorkNew York10021
Caela Startzenbach
[email protected]
212-772-0740
Doris Day, MD (PRINCIPAL_INVESTIGATOR)

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