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

Primary Purpose

Acne Scarring of the Face

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Autologous Human Fibroblasts (azficel-T)
Placebo
Sponsored by
Castle Creek Biosciences, LLC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Scarring of the Face focused on measuring Acne

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brighton Medical Corporation
  • Therapeutics Clinical Research
  • The Laser Institute for Dermatology
  • Dermatology Research Institute, LLC
  • Maryland Laser, Skin and Vein Institute
  • Sadick Dermatology
  • Dermatology, Laser and Vein Specialists of the Carolinas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Double blinded active

Double blinded placebo

Arm Description

Subject will receive autologous fibroblast treatment on either their left or right side of their face

Subject will receive placebo treatment on the opposite side of the face from active treatment

Outcomes

Primary Outcome Measures

Evaluator Live Acne Scarring Assessment Responders
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
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
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
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.

Full Information

First Posted
March 19, 2008
Last Updated
July 19, 2013
Sponsor
Castle Creek Biosciences, LLC.
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1. Study Identification

Unique Protocol Identification Number
NCT00642642
Brief Title
Safety and Efficacy Study of Autologous Fibroblasts in the Treatment of Severe Facial Acne Scarring
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 Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Castle Creek Biosciences, LLC.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scarring of the Face
Keywords
Acne

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Double blinded active
Arm Type
Experimental
Arm Description
Subject will receive autologous fibroblast treatment on either their left or right side of their face
Arm Title
Double blinded placebo
Arm Type
Placebo Comparator
Arm Description
Subject will receive placebo treatment on the opposite side of the face from active treatment
Intervention Type
Biological
Intervention Name(s)
Autologous Human Fibroblasts (azficel-T)
Other Intervention Name(s)
LAVIV
Intervention Description
Collection of 3 mm post auricular skin punch biopsies. Administration of 3 study treatments administered 14 ± 7 days apart.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Collection of 3 mm post auricular skin punch biopsies. Administration of 3 study treatments administered 14 ± 7 days apart.
Primary Outcome Measure Information:
Title
Evaluator Live Acne Scarring Assessment Responders
Description
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.
Time Frame
Baseline (prior to first treatment) and four months after last treatment
Title
Subject Live Acne Scarring Assessment Responders
Description
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.
Time Frame
Baseline (prior to first treatment) and four months after last treatment
Secondary Outcome Measure Information:
Title
Evaluator Live Acne Scarring Assessment Responders
Description
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.
Time Frame
Baseline (prior to first treatment) compared to one, two, and three months after last treatment
Title
Subject Live Acne Scarring Assessment Responders
Description
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.
Time Frame
Baseline (prior to first treatment) compared to one, two, and three months after last treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, between 18 years and 65 years of age. Investigator assessment of the acne scarring on each cheek of moderate to severe. A history of acne scarring for more than 3 years. Subject assesses the appearance of both sides of their facial acne scars as dissatisfied or very dissatisfied with appearance. Exclusion Criteria: Significant active acne. Use of oral antibiotic or retinoid active acne therapy within one year of enrollment. Presence of hypertrophic scars on the cheeks. More than 20% of treatment area comprised of ice pick scars or sinus tracts Treatment area per cheek is less than 9 cm x cm Unilateral or unbalanced acne scar distribution. Physical attributes which prevent the assessment or treatment of the acne scars. 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. Previous treatment with Isolagen TherapyTM. Use of Isotretinoin within one year of enrollment into study. Use of permanent or semi-permanent dermal fillers in the treatment areas within defined time frames. Disorders or drugs that increase bleeding or clotting. Pregnant or lactating women or women trying to become pregnant during the study. Excessive exposure to sun. Smoking more than ½ pack of cigarettes per day.
Facility Information:
Facility Name
Brighton Medical Corporation
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
The Laser Institute for Dermatology
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Dermatology Research Institute, LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Maryland Laser, Skin and Vein Institute
City
Hunt Valley
State/Province
Maryland
ZIP/Postal Code
21030
Country
United States
Facility Name
Sadick Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Dermatology, Laser and Vein Specialists of the Carolinas
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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