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NCT00655356 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Isolagen Therapy in the Treatment of Nasolabial Fold Wrinkles
A Phase 3 study, sponsored by Castle Creek Biosciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 218
- Enrollment target
NCT00655356: Completed Phase 3 study, sponsored by Castle Creek Biosciences.
NCT00655356 is a Phase 3 study that has completed, run by Castle Creek Biosciences. The registered enrollment target is 218 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00655356, a Phase 3 study, has completed, sponsored by Castle Creek Biosciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 218 participants
- Enrollment target
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.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Autologous Human Fibroblasts (azficel-T)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2006-11 |
| Est. Completion | 2009-05 |
| Phase | Phase 3 |
What the finished NCT00655356 record still lists
NCT00655356 is an interventional study that assigns participants to a tested intervention. The registered 218 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 (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00655356 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00655356 about?
NCT00655356 is a clinical study titled "Safety and Efficacy Study of Isolagen Therapy 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 NCT00655356?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 218 participants. The study started on 2006-11. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00655356?
The interventions under investigation include: Placebo (BIOLOGICAL), Autologous Human Fibroblasts (azficel-T) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00655356?
This trial is sponsored by Castle Creek Biosciences, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00655356's enrollment target sits among peer trials
218 1331st of 2000 higher than 669 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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