Back to resultsIntron A for the Treatment of Hypertrophic Scar
Primary Purpose
Burn, Hypertrophic Scar
Status
Withdrawn
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
interferon alpha 2b
Sponsored by
About this trial
This is an interventional treatment trial for Burn focused on measuring burn, hypertrophic scar, fibroproliferative disorder
Eligibility Criteria
Inclusion Criteria:
- burns > 5% tbsa
- informed consent
- no prior exposure to interferon or other cytokines
Exclusion Criteria:
- history of cardiac or CNS disorder or disease
- autoimmune disease
- immunodeficiency
- abnormal renal or hepatic function
- pregnancy
- serious intercurrent illness
- active infection
- malnutrition
- active drug or alcohol abuse
Sites / Locations
- University of Alberta
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
interferon alpha 2b (Intron A)
Placebo
Arm Description
1 million IU of interferon alpha 2b (Intron A) subcutaneously once a day for 7 days, then 3 million IU of interferon alpha 2b (Intron A) subcutaneously three times a week for 23 weeks.
Placebo administered subcutaneously once a day for 7 days, then three times a week for 23 weeks.
Outcomes
Primary Outcome Measures
Systemic effect of Intron A on hypertrophic scar
standardized photographs of scar, scar volume, Vancouver Burn Scar Assessment (VBSA), blood work (TGF-beta, histamine), urine collection (histamine), biopsy of HTS and adjacent normal skin.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00686478
Brief Title
Intron A for the Treatment of Hypertrophic Scar
Official Title
A Double-blind Placebo Controlled Trial Using Subcutaneous Injections of Intron A for the Treatment of Hypertrophic Scar
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Withdrawn
Why Stopped
The trial is not being done at this time
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study assesses the intervention with antifibrotic agents, specifically interferon (IFN) to reduce the magnitude and duration of hypertrophic scar. Burn patients with hypertrophic scar are randomly assigned to either an intervention IFN group or a placebo control group by subcutaneous injection three times a week. Patients are assessed using cutometer, mexameter, standardized photography, urinalysis, blood work, tissue biopsies and the Vancouver Burn Scar Assessment (VBSA) which rates selected HTS based on color, vascularity, height, pliability, itchiness and pain sensitivity. Once on treatment patients are assessed monthly for the six month treatment period.
Detailed Description
Burn patients being followed and treated in the Outpatient Burn Clinic with large areas of HTS are approached to participate in the study. Patients who agree to participate and who have signed an informed consent are entered into the trial.
Pre-treatment evaluation and monthly examinations include:
standardized photographs of scar
scar volume
Vancouver Burn Scar Assessment (VBSA)
blood work (TGF-beta, histamine)
urine collection (histamine)
6mm punch biopsy of HTS and adjacent normal skin (every two months)
Patients are randomized to received with placebo or Intron A 1x106 IU a day for 7 days, then 3x106 IU 3 SC, three times a week for 23 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn, Hypertrophic Scar
Keywords
burn, hypertrophic scar, fibroproliferative disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
interferon alpha 2b (Intron A)
Arm Type
Experimental
Arm Description
1 million IU of interferon alpha 2b (Intron A) subcutaneously once a day for 7 days, then 3 million IU of interferon alpha 2b (Intron A) subcutaneously three times a week for 23 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered subcutaneously once a day for 7 days, then three times a week for 23 weeks.
Intervention Type
Drug
Intervention Name(s)
interferon alpha 2b
Other Intervention Name(s)
intron a
Intervention Description
1 million IU of interferon alpha 2b (Intron A) subcutaneously once a day for 7 days, then 3 million IU of interferon alpha 2b (Intron A) subcutaneously three times a week for 23 weeks.
Primary Outcome Measure Information:
Title
Systemic effect of Intron A on hypertrophic scar
Description
standardized photographs of scar, scar volume, Vancouver Burn Scar Assessment (VBSA), blood work (TGF-beta, histamine), urine collection (histamine), biopsy of HTS and adjacent normal skin.
Time Frame
once / month for 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
burns > 5% tbsa
informed consent
no prior exposure to interferon or other cytokines
Exclusion Criteria:
history of cardiac or CNS disorder or disease
autoimmune disease
immunodeficiency
abnormal renal or hepatic function
pregnancy
serious intercurrent illness
active infection
malnutrition
active drug or alcohol abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward E Tredget, MD MSc FRCSC
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Intron A for the Treatment of Hypertrophic Scar
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