Safety and Efficacy Study of Autologous Fibroblasts in the Treatment of Severe Facial Acne Scarring

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fibrocell Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00642642
First received: March 19, 2008
Last updated: July 19, 2013
Last verified: July 2013
  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 acne scars.


Condition Intervention Phase
Acne Scarring of the Face
Biological: Autologous Human Fibroblasts (azficel-T)
Biological: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II/III Double-Blind, Randomized, Placebo-Controlled Trial of the Safety and Efficacy of Isolagen Therapy in the Treatment of Moderate to Sever Facial Acne Scarring

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Evaluator Live Acne Scarring Assessment Responders [ Time Frame: Baseline (prior to first treatment) and four months after last treatment ] [ Designated as safety issue: No ]
    Subjects who improved by 1 point or more on the Evaluator Live Acne Scarring Assessment (ELASA), as assessed by the evaluating Investigator, are counted as responders. On the ELASA scale, a score of 0 (Clear) is best and a score of 4 (Severe) is worst.

  • Subject Live Acne Scarring Assessment Responders [ Time Frame: Baseline (prior to first treatment) and four months after last treatment ] [ Designated as safety issue: No ]
    Cheeks that improved by at least two points on the Subject Live Acne Scarring Assessment (SLASA) as scored by the subject were considered responders. On the SLASA scale, a score of -2 (Very Dissatisfied) was worst and a score of 2 (Very Satisfied) was best.


Secondary Outcome Measures:
  • Evaluator Live Acne Scarring Assessment Responders [ Time Frame: Baseline (prior to first treatment) compared to one, two, and three months after last treatment ] [ Designated as safety issue: No ]
    Subjects who improved by 1 point or more on the Evaluator Live Acne Scarring Assessment (ELASA), as assessed by the evaluating Investigator, are counted as responders. On the ELASA scale, a score of 0 (Clear) is best and a score of 4 (Severe) is worst.

  • Subject Live Acne Scarring Assessment Responders [ Time Frame: Baseline (prior to first treatment) compared to one, two, and three months after last treatment ] [ Designated as safety issue: No ]
    Cheeks that improved by at least two points on the Subject Live Acne Scarring Assessment (SLASA) as scored by the subject were considered responders. On the SLASA scale, a score of -2 (Very Dissatisfied) was worst and a score of 2 (Very Satisfied) was best.


Enrollment: 122
Study Start Date: November 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Double blinded active
Subject will receive autologous fibroblast treatment on either their left or right side of their face
Biological: Autologous Human Fibroblasts (azficel-T)
  1. Collection of 3 mm post auricular skin punch biopsies.
  2. Administration of 3 study treatments administered 14 ± 7 days apart.
Other Name: LAVIV
Placebo Comparator: Double blinded placebo
Subject will receive placebo treatment on the opposite side of the face from active treatment
Biological: Placebo
  1. Collection of 3 mm post auricular skin punch biopsies.
  2. Administration of 3 study treatments administered 14 ± 7 days apart.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, between 18 years and 65 years of age.
  2. Investigator assessment of the acne scarring on each cheek of moderate to severe.
  3. A history of acne scarring for more than 3 years.
  4. Subject assesses the appearance of both sides of their facial acne scars as dissatisfied or very dissatisfied with appearance.

Exclusion Criteria:

  1. Significant active acne.
  2. Use of oral antibiotic or retinoid active acne therapy within one year of enrollment.
  3. Presence of hypertrophic scars on the cheeks.
  4. More than 20% of treatment area comprised of ice pick scars or sinus tracts
  5. Treatment area per cheek is less than 9 cm x cm
  6. Unilateral or unbalanced acne scar distribution.
  7. Physical attributes which prevent the assessment or treatment of the acne scars.
  8. Treatment with an investigational product or procedure within 30 days prior to study enrollment or plans to participate in another clinical trial during the course of this study.
  9. Previous treatment with Isolagen TherapyTM.
  10. Use of Isotretinoin within one year of enrollment into study.
  11. Use of permanent or semi-permanent dermal fillers in the treatment areas within defined time frames.
  12. Disorders or drugs that increase bleeding or clotting.
  13. Pregnant or lactating women or women trying to become pregnant during the study.
  14. Excessive exposure to sun.
  15. Smoking more than ½ pack of cigarettes per day.
  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: NCT00642642

Locations
United States, California
Brighton Medical Corporation
Beverly Hills, California, United States, 90210
Therapeutics Clinical Research
San Diego, California, United States, 92123
The Laser Institute for Dermatology
Santa Monica, California, United States, 90404
United States, Florida
Dermatology Research Institute, LLC
Coral Gables, Florida, United States, 33146
United States, Maryland
Maryland Laser, Skin and Vein Institute
Hunt Valley, Maryland, United States, 21030
United States, New York
Sadick Dermatology
New York, New York, United States, 10021
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: NCT00642642     History of Changes
Other Study ID Numbers: IT-A-008
Study First Received: March 19, 2008
Results First Received: February 9, 2012
Last Updated: July 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Fibrocell Technologies, Inc.:
Acne

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014