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Safety and Efficacy Study of Autologous Fibroblasts in the Treatment of Severe Facial Acne Scarring

NCT00642642 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2013-08-21

Study results available
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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.

Conditions

  • Acne Scarring of the Face

Interventions

BIOLOGICAL

Autologous Human Fibroblasts (azficel-T)

1. Collection of 3 mm post auricular skin punch biopsies. 2. Administration of 3 study treatments administered 14 ± 7 days apart.

BIOLOGICAL

Placebo

1. Collection of 3 mm post auricular skin punch biopsies. 2. Administration of 3 study treatments administered 14 ± 7 days apart.

Sponsors & Collaborators

  • Castle Creek Biosciences, LLC.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00642642 on ClinicalTrials.gov