Intron A for the Treatment of Hypertrophic Scar

NCT ID: NCT00686478

Last Updated: 2014-01-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL

Brief 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.

Detailed 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.

Conditions

Burn; Hypertrophic Scar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

interferon alpha 2b (Intron A)

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 Type: EXPERIMENTAL

interferon alpha 2b

Intervention Type: DRUG

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.

Placebo

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

Group Type: PLACEBO_COMPARATOR

interferon alpha 2b

Intervention Type: DRUG

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.

Interventions

interferon alpha 2b

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.

Intervention Type: DRUG

Other Intervention Names

intron a

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Ted Tredget

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward E Tredget, MD MSc FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

IFN - 1598

Identifier Type: -

Identifier Source: org_study_id