Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Facial Wrinkles and Creases
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Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment [ Time Frame: Baseline (prior to first treatment) compared to 6 months post last treatment ]
Subject Wrinkle Assessment was a five point ordinal scale that assessed the subject's assessment of the appearance of their face. A score of -2 (very dissatisfied) was the worst and a score of +2 (very satisfied) was the best.
Independent Panel Global Improvement Assessment Compared to Baseline [ Time Frame: Baseline (prior to treatment) compared to 6 months post last treatment ]
An independent panel of physicians reviewed photographs of subjects at baseline and 6 months after final study treatment and provided a score for improvement in appearance on the Global Improvement Assessment. The Global Improvement Assessment was a four point ordinal scale with 0 (No improvement) as the worst score and 3 (Marked Improvement) the best.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female, at least 18 years of age
High Investigator wrinkle severity assessment score
Subject assessment of dissatisfaction of facial appearance
Provide written informed consent and comply with the study requirements