Trials / Completed
CompletedNCT04225273
Extension Study for 43USSA1705
Open Label Extension Study for 43USSA1705 (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
- 38 (actual)
- Sponsor
- Galderma R&D · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the long-term 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, Lidocaine HCL | No intervention was administered during this extension study. |
Timeline
- Start date
- 2019-12-03
- Primary completion
- 2021-01-29
- Completion
- 2021-01-29
- First posted
- 2020-01-13
- Last updated
- 2025-03-12
- Results posted
- 2025-03-12
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04225273. Inclusion in this directory is not an endorsement.