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Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles

NCT00649428 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2012-03-13

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 compared with placebo when administered to bilateral nasolabial fold wrinkles.

Conditions

  • Bilateral Nasolabial Fold Wrinkles

Interventions

BIOLOGICAL

Autologous Human Fibroblast (azficel-T)

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.

BIOLOGICAL

Placebo

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.

Sponsors & Collaborators

  • Castle Creek Biosciences, LLC.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-07-31
Completion
2009-05-31

Countries

  • United States

Study Locations

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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 NCT00649428 on ClinicalTrials.gov