At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 50 enrolled
Drug / intervention
Autologous Human Fibroblasts (azficel-T)biological
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.
Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Facial Wrinkles and Creases
In Brief
A Phase 2 clinical trial evaluating Autologous Human Fibroblasts (azficel-T) for Facial Wrinkles and Creases. Completed, enrolled 50 participants across 5 sites.
Detailed Summary
The purpose of this study is to evaluate the safety profile and the treatment effect of autologous human fibroblasts and placebo when administered to facial wrinkles and creases
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFacial Wrinkles and Creases
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2007
First PostedApr 2008
Primary CompletionJun 2008
TodayJul 2026
First PostedApr 9, 2008
Enrollment StartMar 1, 2007
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.2 years ago
Interventions
Autologous Human Fibroblasts (azficel-T)biological
1. Collection of 3 mm biopsies 2. Two injection treatments of facial wrinkles and creases 3. Conduct of study assessments