Trials / Completed
CompletedNCT03780244
Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.
A Randomized, Evaluator-blinded, Multi-center Study to Evaluate the Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- Galderma R&D · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Accepted
Summary
This study has been designed to evaluate the safety of Sculptra Aesthetic as a single regimen for correction of Nasolabial Fold (NLF) contour deficiencies after changes in reconstitution and injection procedures compared to the approved label.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sculptra Aesthetic 8ml | Treatment of nasolabial folds |
| DEVICE | Sculptra Aesthetic 5ml | Treatment of nasolabial folds |
Timeline
- Start date
- 2018-12-18
- Primary completion
- 2020-02-28
- Completion
- 2020-02-28
- First posted
- 2018-12-19
- Last updated
- 2022-11-14
- Results posted
- 2022-11-14
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03780244. Inclusion in this directory is not an endorsement.