NCT07342400

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Galderma R&D · Industry
• Sex: Female
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a randomized, prospective study. This study will enroll approximately 40 subjects across two sites. All subjects have moderate-to-severe cheek wrinkles on both cheeks. Eligible subjects will first receive punch biopsy on one pre-auricular side according to a pre-determined randomization, followed by a first Sculptra treatment on both cheeks starting at the pre-auricular areas first at Baseline visit. Subjects will receive second Sculptra treatment at Week 4, and an optional third treatment at Week 8. At 12 weeks since last Sculptra treatment, half of the subjects will receive a second punch biopsy on the other pre-auricular side (per randomization). Subjects will have a follow up visit at 24 weeks since last Sculptra treatment. At 36 weeks since last Sculptra treatment, the remaining half will receive a second punch biopsy on the other pre-auricular side (per randomization).

Conditions

• Cheek Wrinkles
• Menopausal Women

Interventions

Type	Name	Description
DEVICE	Sculptra®	Biostimulator

Timeline

• Start date: 2025-08-12
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2026-01-15
• Last updated: 2026-01-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study