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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Acne Scarring of the Face

In brief

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.

Key facts

Study ID

NCT00642642

Run by

Castle Creek Biosciences, LLC.

People needed

122

Starts

2007-11-01

Expected to finish

2009-03-01

Last updated by the study team

2013-08-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, between 18 years and 65 years of age.
• Investigator assessment of the acne scarring on each cheek of moderate to severe.
• A history of acne scarring for more than 3 years.
• Subject assesses the appearance of both sides of their facial acne scars as dissatisfied or very dissatisfied with appearance.

You may not qualify if…

• Significant active acne.
• Use of oral antibiotic or retinoid active acne therapy within one year of enrollment.
• Presence of hypertrophic scars on the cheeks.
• More than 20% of treatment area comprised of ice pick scars or sinus tracts
• Treatment area per cheek is less than 9 cm x cm
• Unilateral or unbalanced acne scar distribution.
• Physical attributes which prevent the assessment or treatment of the acne scars.
• Treatment with an investigational product or procedure within 30 days prior to study enrollment or plans to participate in another clinical trial during the course of this study.
• Previous treatment with Isolagen TherapyTM.
• Use of Isotretinoin within one year of enrollment into study.
• Use of permanent or semi-permanent dermal fillers in the treatment areas within defined time frames.
• Disorders or drugs that increase bleeding or clotting.
• Pregnant or lactating women or women trying to become pregnant during the study.
• Excessive exposure to sun.
• Smoking more than ½ pack of cigarettes per day.

Where it is running

• Brighton Medical Corporation — Beverly Hills, California, United States
• Therapeutics Clinical Research — San Diego, California, United States
• The Laser Institute for Dermatology — Santa Monica, California, United States
• Dermatology Research Institute, LLC — Coral Gables, Florida, United States
• Maryland Laser, Skin and Vein Institute — Hunt Valley, Maryland, United States
• Sadick Dermatology — New York, New York, United States
• Dermatology, Laser and Vein Specialists of the Carolinas — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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