The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM compared with placebo when administered to bilateral nasolabial fold wrinkles.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
218
1. Collection of 3 mm post auricular skin punch biopsies. 2. Three treatment visits with injections administered 5 ± 1 weeks apart on each side of the face.
1. Collection of 3 mm post auricular skin punch biopsies. 2. Three treatment visits with injections administered 5 ± 1 weeks apart on each side of the face.
Brighton Medical Corporation
Beverly Hills, California, United States
Therapeutics Clinical Research
San Diego, California, United States
Gwinnett Clinical Research Center
Snellville, Georgia, United States
Dermatology San Antonio
San Antonio, Texas, United States
Subject Wrinkle Assessment Responders
A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.
Time frame: Baseline (prior to first treatment) and 6 months post final treatment
Evaluator Wrinkle Severity Assessment Responders
A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.
Time frame: Baseline (prior to first treatment) and 6 months after last treatment
Subject Wrinkle Assessment Responders
A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.
Time frame: Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment
Evaluator Wrinkle Severity Assessment Responders
A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.
Time frame: Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment
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Charlottesville Medical Research
Charlottesville, Virginia, United States
Institute of Anti Aging Research
Virginia Beach, Virginia, United States