Intron A for the Treatment of Hypertrophic Scar

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Double-blind Placebo Controlled Trial Using Subcutaneous Injections of Intron A for the Treatment of Hypertrophic Scar

Conditions
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Burn, Hypertrophic Scar

Intervention / Treatment
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* Drug: interferon alpha 2b


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interferon alpha 2b (Intron A)<br>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. | Drug: interferon alpha 2b<br>* 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.<br>* Other names: intron a;|
| Placebo Comparator: Placebo<br>Placebo administered subcutaneously once a day for 7 days, then three times a week for 23 weeks. | Drug: interferon alpha 2b<br>* 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.<br>* Other names: intron a;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | once / month for 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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burn, hypertrophic scar, fibroproliferative disorder