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

July 19, 2013 updated by: Castle Creek Biosciences, LLC.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90210
        • Brighton Medical Corporation
      • San Diego, California, United States, 92123
        • Therapeutics Clinical Research
      • Santa Monica, California, United States, 90404
        • The Laser Institute for Dermatology
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Dermatology Research Institute, LLC
    • Maryland
      • Hunt Valley, Maryland, United States, 21030
        • Maryland Laser, Skin and Vein Institute
    • New York
      • New York, New York, United States, 10021
        • Sadick Dermatology
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Dermatology, Laser and Vein Specialists of the Carolinas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (prior to first treatment) and four months after last treatment
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.
Baseline (prior to first treatment) and four months after last treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (prior to first treatment) compared to one, two, and three months after last treatment
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.
Baseline (prior to first treatment) compared to one, two, and three months after last treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Castle Creek Biosciences, LLC.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (ESTIMATE)

March 25, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 21, 2013

Last Update Submitted That Met QC Criteria

July 19, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IT-A-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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