An Open-label Study of Poly-l-lactic Acid for Correction of Wrinkles in the décolletage Area
NCT05538728 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2024-08-20
Summary
This is a prospective open-label study to evaluate safety and effectiveness of two different reconstitution volumes of poly-l-lactic acid (PLLA) for correction of wrinkles in the décolletage area.
Conditions
- Wrinkles in Decolletage
Interventions
- DEVICE
-
poly-l-lactic acid (Sculptra)
Sculptra
Sponsors & Collaborators
-
Galderma R&D
lead INDUSTRY
Principal Investigators
-
Study Director · Galderma R&D
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 22 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-08-31
- Primary Completion
- 2023-08-08
- Completion
- 2023-08-08
- FDA Device
- Yes
Countries
- United States
Study Locations
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