Trials / Completed
CompletedNCT00655356
Safety and Efficacy Study of Isolagen Therapy in the Treatment of Nasolabial Fold Wrinkles
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 218 (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 Fibroblasts (azficel-T) | 1. Collection of 3 mm post auricular skin punch biopsies. 2. Three treatment visits with injections 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 treatment visits with injections administered 5 ± 1 weeks apart on each side of the face. |
Timeline
- Start date
- 2006-11-01
- Primary completion
- 2008-07-01
- Completion
- 2009-05-01
- First posted
- 2008-04-09
- Last updated
- 2012-03-13
- Results posted
- 2012-03-13
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00655356. Inclusion in this directory is not an endorsement.