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

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ClinicalTrials.gov Identifier: NCT00649428
Recruitment Status : Completed
First Posted : April 1, 2008
Results First Posted : March 13, 2012
Last Update Posted : March 13, 2012
Sponsor:
Information provided by (Responsible Party):
Fibrocell Technologies, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Bilateral Nasolabial Fold Wrinkles Biological: Autologous Human Fibroblast (azficel-T) Biological: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Azficel-T
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Subject Wrinkle Assessment Responders [ Time Frame: Baseline (prior to first treatment) and 6 months post final treatment ]
    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.

  2. Evaluator Wrinkle Severity Assessment Responders [ Time Frame: Baseline (prior to first treatment) and 6 months after last treatment ]
    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 :
  1. Subject Wrinkle Assessment Responders [ Time Frame: Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment ]
    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.

  2. Evaluator Wrinkle Severity Assessment Responders [ Time Frame: Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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.

Responsible Party: Fibrocell Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00649428     History of Changes
Other Study ID Numbers: IT-R-005
First Posted: April 1, 2008    Key Record Dates
Results First Posted: March 13, 2012
Last Update Posted: March 13, 2012
Last Verified: February 2012

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