Trials / Completed
CompletedNCT00360932
Facial Lipoatrophy Correction Experience With SCULPTRA ("FACES" Study)
An Open-Label Registry Study of the Facial Lipoatrophy Correction Experience With SCULPTRA® in Subjects With Human Immunodeficiency Virus (FACES Study)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 290 (actual)
- Sponsor
- Bausch Health Americas, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
5 year, open-label study to evaluate safety of SCULPTRA on the signs of lipoatrophy of the face in at least 100 evaluable subjects with human immunodeficiency virus.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SCULPTRA (poly-L-lactic acid injection) | Subjects will be treated with SCULPTRA® according to the investigator's judgment, and in accordance with the SCULPTRA® package insert. Details of the exact amount and the time of administration of SCULPTRA® (date, amount, location) will be documented in the CRF at each protocol and non-protocol visit. |
Timeline
- Start date
- 2005-10-01
- Primary completion
- 2011-08-01
- Completion
- 2011-08-01
- First posted
- 2006-08-07
- Last updated
- 2019-09-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00360932. Inclusion in this directory is not an endorsement.