Intron A for the Treatment of Hypertrophic Scar

Phase 3

Withdrawn

• Conditions: Burn; Hypertrophic Scar
• Interventions: Drug: interferon alpha 2b

• Registration Number: NCT00686478
• Lead Sponsor: University of Alberta

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.

Study Timeline

• Study First Submitted: 2008-05-26
• Study First Submitted QC: 2008-05-28
• Study First Posted: 2008-05-29
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-28
• Last Update Posted: 2014-01-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
interferon alpha 2b (Intron A)	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.
Placebo	interferon alpha 2b	Placebo administered subcutaneously once a day for 7 days, then three times a week for 23 weeks.

Primary Outcome Measures

Name	Time	Method
Systemic effect of Intron A on hypertrophic scar	once / month for 6 months	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.

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada