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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fibrocell Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00654654
First received: April 3, 2008
Last updated: February 9, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Facial Wrinkles and Creases
Biological: Autologous Human Fibroblasts (azficel-T)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (prior to treatment) compared to 6 months post last treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: March 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Fibrocell Technologies, Inc.
  More Information

No publications provided

Responsible Party: Fibrocell Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00654654     History of Changes
Other Study ID Numbers: IT-R-007
Study First Received: April 3, 2008
Results First Received: February 9, 2012
Last Updated: February 9, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 01, 2014