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NCT00649428 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles
A Phase 3 study of Bilateral Nasolabial Fold Wrinkles, sponsored by Castle Creek Biosciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 203
- Enrollment target
- 7
- Study locations
NCT00649428: Completed Phase 3 study of Bilateral Nasolabial Fold Wrinkles, sponsored by Castle Creek Biosciences.
NCT00649428 is a Phase 3 study of Bilateral Nasolabial Fold Wrinkles that has completed, run by Castle Creek Biosciences. The registered enrollment target is 203 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00649428, a Phase 3 study of Bilateral Nasolabial Fold Wrinkles, has completed, sponsored by Castle Creek Biosciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 203 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Autologous Human Fibroblast (azficel-T)
Study Locations (7)
North Carolina
- Aesthetic Solutions - Chapel Hill
- Dermatology, Laser & Vein Specialists of the Carolinas - Charlotte
Alabama
- Total Skin & Beauty Dermatology Center, PC - Birmingham
California
- Silverburg Surgical & Medical Group - Newport Beach
Florida
- Dermatology Research Institute, LLC - Coral Gables
Illinois
- River North Dermatology and Dermatologic Surgery - Naperville
Texas
- Center for Skin Research - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2006-10 |
| Est. Completion | 2009-05 |
| Phase | Phase 3 |
What the finished NCT00649428 record still lists
NCT00649428 is an interventional study that assigns participants to a tested intervention. The registered 203 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Bilateral Nasolabial Fold Wrinkles appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00649428 lists 7 locations in 6 states (North Carolina, Alabama, California).
Frequently Asked Questions
What is clinical trial NCT00649428 about?
NCT00649428 is a clinical study titled "Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles". 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.
What is the current status of trial NCT00649428?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 203 participants. The study started on 2006-10. Estimated completion is 2009-05.
What conditions does trial NCT00649428 study?
This clinical trial studies the following conditions: Bilateral Nasolabial Fold Wrinkles.
What interventions are being tested in trial NCT00649428?
The interventions under investigation include: Placebo (BIOLOGICAL), Autologous Human Fibroblast (azficel-T) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00649428?
This trial is sponsored by Castle Creek Biosciences, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00649428 being conducted?
This trial has 7 study locations across Alabama, California, Florida, Illinois, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00649428's enrollment target sits among peer trials
203 1352nd of 2000 higher than 648 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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