Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Facial Wrinkles and Creases

Phase 2

Completed

Brief Summary: The purpose of this study is to evaluate the safety profile and the treatment effect of autologous human fibroblasts and placebo when administered to facial wrinkles and creases

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Low Investigator wrinkle severity assessment score
Subject assessment of satisfaction of facial appearance
Physical attributes which prevent the assessment or treatment of the facial wrinkles
Treatment with an investigational product or procedure within 30 days or plans to participate in another clinical trial
Previous treatment with Isolagen Therapy
History of active autoimmune disease or organ transplantation
Diagnosis of cancer, receiving active treatment
History of pigmentary disorders which can affect the face
Active or chronic skin disease
Known genetic disorders affecting fibroblasts or collagen
Active systemic infection
Requires chronic antibiotic or steroidal therapy
Use of certain cosmetic treatments & procedures
Use of systemic agents that increase bleeding or clotting, or disorders equated with these effects
Pregnant or lactating women or women trying to become pregnant
Known allergic reaction to components of study treatment and/or study injection procedure
Excessive exposure to sun or sunburn in the post-auricular area
Subject has any disorder that may prevent compliance
Subject who is part of the study staff, a family member or friend

Arm && Interventions

Group	Intervention	Description
Active	Autologous Human Fibroblasts (azficel-T)	-

Primary Outcome Measures

Name	Time	Method
Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment	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	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.

Secondary Outcome Measures

Name	Time	Method

Locations (5): The Laser Institute for Dermatology
🇺🇸
Santa Monica, California, United States
Rhonda Rand, M.D., Inc.
🇺🇸
Beverly Hills, California, United States
Dermatology, Laser and Vein Specialists of the Carolinas
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Charlotte, North Carolina, United States
Dermatology Partners
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Wellesley, Massachusetts, United States
Winter Park and Orlando Plastic Surgery
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Orlando, Florida, United States