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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
122
1. Collection of 3 mm post auricular skin punch biopsies. 2. Administration of 3 study treatments administered 14 ± 7 days apart.
1. Collection of 3 mm post auricular skin punch biopsies. 2. Administration of 3 study treatments administered 14 ± 7 days apart.
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
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.
Time frame: Baseline (prior to first treatment) and four months after last treatment
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.
Time frame: Baseline (prior to first treatment) and four months after last treatment
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.
Time frame: Baseline (prior to first treatment) compared to one, two, and three months after last treatment
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.
Time frame: Baseline (prior to first treatment) compared to one, two, and three months after last treatment
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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