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Antifibrotic Agent
interferon alpha 2b (Intron A) for Hypertrophic Scar
Phase 3
Waitlist Available
Led By Edward E Tredget, MD MSc FRCSC
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up once / month for 6 months
Awards & highlights
Pivotal Trial
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.
Eligible Conditions
- Hypertrophic Scar
- Burns
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ once / month for 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once / month for 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Systemic effect of Intron A on hypertrophic scar
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: interferon alpha 2b (Intron A)Experimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered subcutaneously once a day for 7 days, then three times a week for 23 weeks.
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Who is running the clinical trial?
University of AlbertaLead Sponsor
941 Previous Clinical Trials
434,131 Total Patients Enrolled
Edward E Tredget, MD MSc FRCSCPrincipal InvestigatorUniversity of Alberta
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