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Trial record 1 of 1 for:    Azficel-T, IT-R-007
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Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Facial Wrinkles and Creases

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ClinicalTrials.gov Identifier: NCT00654654
Recruitment Status : Completed
First Posted : April 9, 2008
Results First Posted : March 13, 2012
Last Update Posted : March 13, 2012
Information provided by (Responsible Party):
Castle Creek Biosciences, LLC.

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

Condition or disease Intervention/treatment Phase
Facial Wrinkles and Creases Biological: Autologous Human Fibroblasts (azficel-T) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Azficel-T

Arm Intervention/treatment
Experimental: Active Biological: Autologous Human Fibroblasts (azficel-T)
  1. Collection of 3 mm biopsies
  2. Two injection treatments of facial wrinkles and creases
  3. Conduct of study assessments
Other Name: LAVIV

Primary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654654

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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
Castle Creek Biosciences, LLC.
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Responsible Party: Castle Creek Biosciences, LLC.
ClinicalTrials.gov Identifier: NCT00654654    
Other Study ID Numbers: IT-R-007
First Posted: April 9, 2008    Key Record Dates
Results First Posted: March 13, 2012
Last Update Posted: March 13, 2012
Last Verified: February 2012
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes