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Sponsored by: |
Isolagen Technologies, Inc. |
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Information provided by: | Isolagen Technologies, Inc. |
ClinicalTrials.gov Identifier: | NCT00654654 |
The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM and placebo when administered to facial wrinkles and creases
Condition | Intervention | Phase |
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Facial Wrinkles and Creases |
Biological: Autologous Human Fibroblasts (Isolagen TherapyTM) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Enrollment: | 50 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | January 2009 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Active: Experimental |
Biological: Autologous Human Fibroblasts (Isolagen TherapyTM)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Rhonda Rand, M.D., Inc. | |
Beverly Hills, California, United States, 90210 | |
The Laser Institute for Dermatology | |
Santa Monica, California, United States, 90404 | |
United States, Florida | |
Winter Park and Orlando Plastic Surgery | |
Orlando, Florida, United States, 32804 | |
United States, Massachusetts | |
Dermatology Partners | |
Wellesley, Massachusetts, United States, 02481 | |
United States, North Carolina | |
Dermatology, Laser and Vein Specialists of the Carolinas | |
Charlotte, North Carolina, United States, 28207 |
Responsible Party: | Isolagen Technologies, Inc. ( Dr. Sandra Calman/Chief Medical Officer & VP of Clinical Development ) |
Study ID Numbers: | IT-R-007 |
Study First Received: | April 3, 2008 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00654654 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Facies |