Intron A for the Treatment of Hypertrophic Scar

This study has been withdrawn prior to enrollment.
(The trial is not being done at this time)
Sponsor:
Information provided by (Responsible Party):
Ted Tredget, University of Alberta
ClinicalTrials.gov Identifier:
NCT00686478
First received: May 26, 2008
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Burn
Hypertrophic Scar
Drug: interferon alpha 2b
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind Placebo Controlled Trial Using Subcutaneous Injections of Intron A for the Treatment of Hypertrophic Scar

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Systemic effect of Intron A on hypertrophic scar [ Time Frame: once / month for 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Arms Assigned Interventions
Experimental: 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.
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.
Other Name: intron a
Placebo Comparator: Placebo
Placebo administered subcutaneously once a day for 7 days, then three times a week for 23 weeks.
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.
Other Name: intron a

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686478

Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Edward E Tredget, MD MSc FRCSC University of Alberta
  More Information

No publications provided

Responsible Party: Ted Tredget, Principal Investigator, University of Alberta
ClinicalTrials.gov Identifier: NCT00686478     History of Changes
Other Study ID Numbers: IFN - 1598
Study First Received: May 26, 2008
Last Updated: January 28, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
burn
hypertrophic scar
fibroproliferative disorder

Additional relevant MeSH terms:
Hypertrophy
Cicatrix, Hypertrophic
Cicatrix
Pathological Conditions, Anatomical
Fibrosis
Pathologic Processes
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Reaferon
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Adjuvants, Immunologic
Alcohol Deterrents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014