Trials / Completed
CompletedNCT04124692
Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles
A Randomized, Evaluator-blinded, No-treatment Controlled, Multicenter Study to Evaluate the Effectiveness and Safety of Sculptra Aesthetic for Correction of Cheek Wrinkles.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 149 (actual)
- Sponsor
- Galderma R&D · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Accepted
Summary
The study has been designed to evaluate the safety and effectiveness of Sculptra Aesthetic as a single regimen for correction of cheek wrinkles after changes in reconstitution and injection procedures compared to the approved label.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sculptra Aesthetic new dilution | Treatment of cheek wrinkles |
Timeline
- Start date
- 2019-11-12
- Primary completion
- 2021-08-12
- Completion
- 2021-08-12
- First posted
- 2019-10-11
- Last updated
- 2023-11-18
- Results posted
- 2023-11-18
Locations
13 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04124692. Inclusion in this directory is not an endorsement.