Intron A for the Treatment of Hypertrophic Scar

Burn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00686478
• Other study ID #: IFN - 1598
• Status: Withdrawn
• Phase: Phase 3
• First received: May 26, 2008
• Last updated: January 28, 2014

Study information

• Verified date: January 2014
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burn
• Cicatrix, Hypertrophic
• Hypertrophic Scar
• Hypertrophy

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No