Intron A for the Treatment of Hypertrophic Scar

University of Alberta

Status and phase: Withdrawn; Phase 3

Conditions: Hypertrophic Scar; Burn

Treatments: Drug: interferon alpha 2b

Study type: Interventional

Funder types: Other

Identifiers

NCT00686478

IFN - 1598

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

interferon alpha 2b (Intron A)

Experimental group

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.

Treatment:

Drug: interferon alpha 2b

Placebo

Placebo Comparator group

Description:

Placebo administered subcutaneously once a day for 7 days, then three times a week for 23 weeks.

Treatment:

Drug: interferon alpha 2b