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Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Facial Wrinkles and Creases
This study is ongoing, but not recruiting participants.
First Received: April 3, 2008   Last Updated: August 22, 2008   History of Changes
Sponsored by: Isolagen Technologies, Inc.
Information provided by: Isolagen Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00654654
  Purpose

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
Facial Wrinkles and Creases
Biological: Autologous Human Fibroblasts (Isolagen TherapyTM)
Phase II

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment

Further study details as provided by Isolagen Technologies, Inc.:

Primary Outcome Measures:
  • Subject and Independent Panel assessment of wrinkles compared to baseline [ Time Frame: 6 months post last treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subject and Investigator skin quality assessment [ Time Frame: 6 months post last treatment ] [ Designated as safety issue: No ]

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
Active: Experimental Biological: Autologous Human Fibroblasts (Isolagen TherapyTM)
  1. Collection of 3 mm biopsies
  2. Two injection treatments of facial wrinkles and creases
  3. Conduct of study assessments

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654654

Locations
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
Sponsors and Collaborators
Isolagen Technologies, Inc.
  More Information

No publications provided

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

Study placed in the following topic categories:
Facies

ClinicalTrials.gov processed this record on May 07, 2009