CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 203 enrolled
Drug / intervention
Autologous Human Fibroblast (azficel-T) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00649428
NCT00649428Phase 3Completed
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Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles

Castle Creek Biosciences, LLC.·interventional·Posted Apr 1, 2008·Updated Mar 13, 2012

In Brief

A Phase 3 clinical trial evaluating Autologous Human Fibroblast (azficel-T) and Placebo for Bilateral Nasolabial Fold Wrinkles. Completed, enrolled 203 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBilateral Nasolabial Fold Wrinkles
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 1, 2008
Enrollment StartOct 1, 2006
Primary CompletionJul 1, 2008
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.3 years ago

Interventions

Autologous Human Fibroblast (azficel-T)biological

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.

Placebobiological

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.