Intron A for the Treatment of Hypertrophic Scar

University of Alberta

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Burn Hypertrophic Scar

Interventions

interferon alpha 2bDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Alberta

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

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.

Time frame: once / month for 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.