Clinical Trial: Intron A for the Treatment of Hypertrophic Scar

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University of Alberta

Current Primary Outcome: Systemic effect of Intron A on hypertrophic scar [ Time Frame: 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.


Original Primary Outcome: Time [ Time Frame: 6 months ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Alberta

Dates:
Date Received: May 26, 2008
Date Started:
Date Completion:
Last Updated: January 28, 2014
Last Verified: January 2014