At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 122 enrolled
Drug / intervention
Autologous Human Fibroblasts (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.
A Phase II/III Double-Blind, Randomized, Placebo-Controlled Trial of the Safety and Efficacy of Isolagen Therapy in the Treatment of Moderate to Sever Facial Acne Scarring
In Brief
A Phase 3 clinical trial evaluating Autologous Human Fibroblasts (azficel-T) and Placebo for Acne Scarring of the Face. Completed, enrolled 122 participants across 7 sites.
Detailed Summary
The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM and placebo when administered to facial acne scars.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Scarring of the Face
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2007
First PostedMar 2008
Primary CompletionMar 2009
TodayJul 2026
First PostedMar 25, 2008
Enrollment StartNov 1, 2007
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.3 years ago
Interventions
Autologous Human Fibroblasts (azficel-T)biological
1. Collection of 3 mm post auricular skin punch biopsies. 2. Administration of 3 study treatments administered 14 ± 7 days apart.
Placebobiological
1. Collection of 3 mm post auricular skin punch biopsies. 2. Administration of 3 study treatments administered 14 ± 7 days apart.