Status:
COMPLETED
Safety and Efficacy Study of Autologous Fibroblasts in the Treatment of Severe Facial Acne Scarring
Lead Sponsor:
Castle Creek Biosciences, LLC.
Conditions:
Acne Scarring of the Face
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00642642
Start Date
November 1 2007
End Date
March 1 2009
Last Update
August 21 2013
Active Locations (7)
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1
Brighton Medical Corporation
Beverly Hills, California, United States, 90210
2
Therapeutics Clinical Research
San Diego, California, United States, 92123
3
The Laser Institute for Dermatology
Santa Monica, California, United States, 90404
4
Dermatology Research Institute, LLC
Coral Gables, Florida, United States, 33146