Safety and Efficacy Study of Autologous Fibroblasts in the Treatment of Severe Facial Acne Scarring
NCT ID: NCT00642642
Last Updated: 2013-08-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
122 participants
INTERVENTIONAL
2007-11-30
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Double blinded active
Subject will receive autologous fibroblast treatment on either their left or right side of their face
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.
Double blinded placebo
Subject will receive placebo treatment on the opposite side of the face from active treatment
Placebo
1. Collection of 3 mm post auricular skin punch biopsies.
2. Administration of 3 study treatments administered 14 ± 7 days apart.
Interventions
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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.
Placebo
1. Collection of 3 mm post auricular skin punch biopsies.
2. Administration of 3 study treatments administered 14 ± 7 days apart.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Investigator assessment of the acne scarring on each cheek of moderate to severe.
3. A history of acne scarring for more than 3 years.
4. Subject assesses the appearance of both sides of their facial acne scars as dissatisfied or very dissatisfied with appearance.
Exclusion Criteria
2. Use of oral antibiotic or retinoid active acne therapy within one year of enrollment.
3. Presence of hypertrophic scars on the cheeks.
4. More than 20% of treatment area comprised of ice pick scars or sinus tracts
5. Treatment area per cheek is less than 9 cm x cm
6. Unilateral or unbalanced acne scar distribution.
7. Physical attributes which prevent the assessment or treatment of the acne scars.
8. 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.
9. Previous treatment with Isolagen TherapyTM.
10. Use of Isotretinoin within one year of enrollment into study.
11. Use of permanent or semi-permanent dermal fillers in the treatment areas within defined time frames.
12. Disorders or drugs that increase bleeding or clotting.
13. Pregnant or lactating women or women trying to become pregnant during the study.
14. Excessive exposure to sun.
15. Smoking more than ½ pack of cigarettes per day.
18 Years
65 Years
ALL
No
Sponsors
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Castle Creek Biosciences, LLC.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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IT-A-008
Identifier Type: -
Identifier Source: org_study_id