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

Completed · Phase 2

Conditions studied: Facial Wrinkles and Creases

In brief

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

Key facts

Study ID

NCT00654654

Run by

Castle Creek Biosciences, LLC.

People needed

50

Starts

2007-03-01

Expected to finish

2008-06-01

Last updated by the study team

2012-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Negative pregnancy test at screening visit
• Healthy, non-scarred skin for biopsy

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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