Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fibrocell Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00649428
First received: March 27, 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 Isolagen TherapyTM compared with placebo when administered to bilateral nasolabial fold wrinkles.


Condition Intervention Phase
Bilateral Nasolabial Fold Wrinkles
Biological: Autologous Human Fibroblast (azficel-T)
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Subject Wrinkle Assessment Responders [ Time Frame: Baseline (prior to first treatment) and 6 months post final treatment ] [ Designated as safety issue: No ]
    A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.

  • Evaluator Wrinkle Severity Assessment Responders [ Time Frame: Baseline (prior to first treatment) and 6 months after last treatment ] [ Designated as safety issue: No ]
    A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.


Secondary Outcome Measures:
  • Subject Wrinkle Assessment Responders [ Time Frame: Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment ] [ Designated as safety issue: No ]
    A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.

  • Evaluator Wrinkle Severity Assessment Responders [ Time Frame: Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment ] [ Designated as safety issue: No ]
    A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.


Enrollment: 203
Study Start Date: October 2006
Study Completion Date: May 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Biological: Autologous Human Fibroblast (azficel-T)
  1. Collection of 3 mm post auricular skin punch biopsies.
  2. Three injection treatments administered 5 ± 1 weeks apart on each side of the face.
Other Name: LAVIV
Placebo Comparator: Control Biological: Placebo
  1. Collection of 3 mm post auricular skin punch biopsies.
  2. Three injection visits administered 5 ± 1 weeks apart on each side of the face.

  Eligibility

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

Inclusion Criteria:

  • Subject is at least 18 years of age
  • Level of severity of bilateral nasolabial fold wrinkles meeting severity criteria as per protocol
  • Level of subject dissatisfaction with both nasolabial fold wrinkles as per protocol
  • Ability to comply with the study requirements
  • Negative pregnancy test (Females)
  • Healthy post-auricular skin for biopsy

Exclusion Criteria:

  • Excessive dermatochalasis of the treatment area
  • Inability to lessen the nasolabial fold wrinkles by physically spreading the area apart
  • Total area to be treated exceeds 20 cm in length
  • Physical attributes which may prevent assessment or treatment as judged by the evaluator
  • Use of an investigational product/procedure within 30 days prior to enrollment or plans for use during the study
  • Previous treatment with the sponsor's product
  • History of active autoimmune disease or organ transplantation
  • Diagnosis of cancer, unless successfully treated or in remission (basal cell carcinoma is excluded)
  • Active or chronic skin disease
  • Known genetic disorders affecting fibroblasts or collagen
  • Active systemic infection
  • Requires chronic antibiotic or steroidal therapy
  • Use of certain commercial products/procedures to the treatment area prior to study enrollment or plans for use during the study
  • Use of systemic agents that increase bleeding or clotting, or disorders equated with these effects
  • Known allergic reactions to agents used in preparation of treatment
  • Excessive exposure to sun without adequate sun protection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00649428

Locations
United States, Alabama
Total Skin & Beauty Dermatology Center, PC
Birmingham, Alabama, United States
United States, California
Silverburg Surgical & Medical Group
Newport Beach, California, United States, 92660
United States, Florida
Dermatology Research Institute, LLC
Coral Gables, Florida, United States
United States, Illinois
River North Dermatology and Dermatologic Surgery
Naperville, Illinois, United States
United States, North Carolina
Aesthetic Solutions
Chapel Hill, North Carolina, United States
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, United States
United States, Texas
Center for Skin Research
Houston, Texas, United States
Sponsors and Collaborators
Fibrocell Technologies, Inc.
  More Information

No publications provided

Responsible Party: Fibrocell Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00649428     History of Changes
Other Study ID Numbers: IT-R-005
Study First Received: March 27, 2008
Results First Received: February 9, 2012
Last Updated: February 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Fibrocell Technologies, Inc.:
Treatment of moderate to severe bilateral nasolabial fold wrinkles

ClinicalTrials.gov processed this record on April 17, 2014