Trials / Completed
CompletedNCT00869687
Biopsy Study for Sculptra (Poly-L-Lactic Acid)
A Single Group Study for the Characterization of Human Tissue Response to Injectable Poly-L-Lactic Acid (Sculptra) in Healthy Volunteers
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Bausch Health Americas, Inc. · Industry
- Sex
- All
- Age
- 35 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of this study involves research to evaluate new collagen (the elastic fibers that provide skin with its strength and resilience) formation in the skin following injections of Sculptra (Poly-L-Lactic Acid or PLLA). The secondary objectives of the study are to better understand the human skin responses to Sculptra and to assess the safety of Sculptra injections.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Poly-L-Lactic Acid Injection | 0.05 mL of poly-l-lactic acid will be injected as depot at three (3) points (a total of 0.15 mL). |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2010-05-01
- Completion
- 2010-05-01
- First posted
- 2009-03-26
- Last updated
- 2019-11-20
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT00869687. Inclusion in this directory is not an endorsement.