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
203
1. Collection of 3 mm post auricular skin punch biopsies. 2. Three injection treatments administered 5 ± 1 weeks apart on each side of the face.
1. Collection of 3 mm post auricular skin punch biopsies. 2. Three injection visits administered 5 ± 1 weeks apart on each side of the face.
Total Skin & Beauty Dermatology Center, PC
Birmingham, Alabama, United States
Silverburg Surgical & Medical Group
Newport Beach, California, United States
Dermatology Research Institute, LLC
Coral Gables, Florida, United States
River North Dermatology and Dermatologic Surgery
Naperville, Illinois, 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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Aesthetic Solutions
Chapel Hill, North Carolina, United States
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, United States
Center for Skin Research
Houston, Texas, United States