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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00642642
Recruitment Status : Completed
First Posted : March 25, 2008
Results First Posted : August 21, 2013
Last Update Posted : August 21, 2013
Sponsor:
Information provided by (Responsible Party):
Castle Creek Biosciences, LLC.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Acne Scarring of the Face Biological: Autologous Human Fibroblasts (azficel-T) Biological: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : November 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Evaluator Live Acne Scarring Assessment Responders [ Time Frame: Baseline (prior to first treatment) and four months after last treatment ]
    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.

  2. Subject Live Acne Scarring Assessment Responders [ Time Frame: Baseline (prior to first treatment) and four months after last treatment ]
    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 :
  1. Evaluator Live Acne Scarring Assessment Responders [ Time Frame: Baseline (prior to first treatment) compared to one, two, and three months after last treatment ]
    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.

  2. Subject Live Acne Scarring Assessment Responders [ Time Frame: Baseline (prior to first treatment) compared to one, two, and three months after last treatment ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00642642


Locations
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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
Castle Creek Biosciences, LLC.
More Information
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Responsible Party: Castle Creek Biosciences, LLC.
ClinicalTrials.gov Identifier: NCT00642642    
Other Study ID Numbers: IT-A-008
First Posted: March 25, 2008    Key Record Dates
Results First Posted: August 21, 2013
Last Update Posted: August 21, 2013
Last Verified: July 2013
Keywords provided by Castle Creek Biosciences, LLC.:
Acne
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes