Clinical trial NCT00642642: Safety and Efficacy Study of Autologous Fibroblasts in the Treatment of Severe Facial Acne Scarring
Official title: A Phase II/III Double-Blind, Randomized, Placebo-Controlled Trial of the Safety and Efficacy of Isolagen Therapy in the Treatment of Moderate to Sever Facial Acne Scarring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acne Scarring of the Face
Keywords: Acne
Lead sponsor: Castle Creek Biosciences, LLC.
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

1. Male or female, between 18 years and 65 years of age.
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:

1. Significant active acne.
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.

Primary outcomes:
measure: Evaluator Live Acne Scarring Assessment Responders
timeFrame: Baseline (prior to first treatment) and four months after last treatment
measure: Subject Live Acne Scarring Assessment Responders
timeFrame: Baseline (prior to first treatment) and four months after last treatment
Secondary outcomes:
measure: Evaluator Live Acne Scarring Assessment Responders
timeFrame: Baseline (prior to first treatment) compared to one, two, and three months after last treatment
measure: Subject Live Acne Scarring Assessment Responders
timeFrame: Baseline (prior to first treatment) compared to one, two, and three months after last treatment
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Brighton Medical Corporation
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Santa Monica
country: United States
facility: The Laser Institute for Dermatology
state: California
city: Coral Gables
country: United States
facility: Dermatology Research Institute, LLC
state: Florida
city: Hunt Valley
country: United States
facility: Maryland Laser, Skin and Vein Institute
state: Maryland
city: New York
country: United States
facility: Sadick Dermatology
state: New York
city: Charlotte
country: United States
facility: Dermatology, Laser and Vein Specialists of the Carolinas
state: North Carolina
Study officials:
References: