Safety and Efficacy Study of Autologous Fibroblasts in the Treatment of Severe Facial Acne Scarring
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
1 other identifier
interventional
122
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2007
Shorter than P25 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 19, 2008
CompletedFirst Posted
Study publicly available on registry
March 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
August 21, 2013
CompletedAugust 21, 2013
July 1, 2013
1.3 years
March 19, 2008
February 9, 2012
July 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Baseline (prior to first treatment) and four months after last treatment
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.
Baseline (prior to first treatment) and four months after last treatment
Secondary Outcomes (2)
Evaluator Live Acne Scarring Assessment Responders
Baseline (prior to first treatment) compared to one, two, and three months after last treatment
Subject Live Acne Scarring Assessment Responders
Baseline (prior to first treatment) compared to one, two, and three months after last treatment
Study Arms (2)
Double blinded active
EXPERIMENTALSubject will receive autologous fibroblast treatment on either their left or right side of their face
Double blinded placebo
PLACEBO COMPARATORSubject will receive placebo treatment on the opposite side of the face from active treatment
Interventions
1. Collection of 3 mm post auricular skin punch biopsies. 2. Administration of 3 study treatments administered 14 ± 7 days apart.
1. Collection of 3 mm post auricular skin punch biopsies. 2. Administration of 3 study treatments administered 14 ± 7 days apart.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Brighton Medical Corporation
Beverly Hills, California, 90210, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
The Laser Institute for Dermatology
Santa Monica, California, 90404, United States
Dermatology Research Institute, LLC
Coral Gables, Florida, 33146, United States
Maryland Laser, Skin and Vein Institute
Hunt Valley, Maryland, 21030, United States
Sadick Dermatology
New York, New York, 10021, United States
Dermatology, Laser and Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr/ Joseph Fratantoni
- Organization
- Biologics Consulting Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2008
First Posted
March 25, 2008
Study Start
November 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
August 21, 2013
Results First Posted
August 21, 2013
Record last verified: 2013-07