Overview

Intron A for the Treatment of Hypertrophic Scar

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Alberta
Treatments:
Interferon alpha-2
Interferon-alpha
Interferons
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