Trials / Completed
CompletedNCT00649428
Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 203 (actual)
- Sponsor
- Castle Creek Biosciences, LLC. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM compared with placebo when administered to bilateral nasolabial fold wrinkles.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Autologous Human Fibroblast (azficel-T) | 1. Collection of 3 mm post auricular skin punch biopsies. 2. Three injection treatments administered 5 ± 1 weeks apart on each side of the face. |
| BIOLOGICAL | Placebo | 1. Collection of 3 mm post auricular skin punch biopsies. 2. Three injection visits administered 5 ± 1 weeks apart on each side of the face. |
Timeline
- Start date
- 2006-10-01
- Primary completion
- 2008-07-01
- Completion
- 2009-05-01
- First posted
- 2008-04-01
- Last updated
- 2012-03-13
- Results posted
- 2012-03-13
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00649428. Inclusion in this directory is not an endorsement.