Acne Scarring of the Face Clinical Trial
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
| Verified date | July 2013 |
| Source | Fibrocell Technologies, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 122 |
| Est. completion date | March 2009 |
| Est. primary completion date | March 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Brighton Medical Corporation | Beverly Hills | California |
| United States | Dermatology, Laser and Vein Specialists of the Carolinas | Charlotte | North Carolina |
| 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 | Therapeutics Clinical Research | San Diego | California |
| United States | The Laser Institute for Dermatology | Santa Monica | California |
| Lead Sponsor | Collaborator |
|---|---|
| Fibrocell Technologies, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluator Live Acne Scarring Assessment Responders | Subjects who improved by 1 point or more on the Evaluator Live Acne Scarring Assessment (ELASA), as assessed by the evaluating Investigator, are counted as responders. On the ELASA scale, a score of 0 (Clear) is best and a score of 4 (Severe) is worst. | Baseline (prior to first treatment) and four months after last treatment | No |
| Primary | Subject Live Acne Scarring Assessment Responders | Cheeks that improved by at least two points on the Subject Live Acne Scarring Assessment (SLASA) as scored by the subject were considered responders. On the SLASA scale, a score of -2 (Very Dissatisfied) was worst and a score of 2 (Very Satisfied) was best. | Baseline (prior to first treatment) and four months after last treatment | No |
| Secondary | Evaluator Live Acne Scarring Assessment Responders | Subjects who improved by 1 point or more on the Evaluator Live Acne Scarring Assessment (ELASA), as assessed by the evaluating Investigator, are counted as responders. On the ELASA scale, a score of 0 (Clear) is best and a score of 4 (Severe) is worst. | Baseline (prior to first treatment) compared to one, two, and three months after last treatment | No |
| Secondary | Subject Live Acne Scarring Assessment Responders | Cheeks that improved by at least two points on the Subject Live Acne Scarring Assessment (SLASA) as scored by the subject were considered responders. On the SLASA scale, a score of -2 (Very Dissatisfied) was worst and a score of 2 (Very Satisfied) was best. | Baseline (prior to first treatment) compared to one, two, and three months after last treatment | No |