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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00686478
First Posted: May 29, 2008
Last Update Posted: January 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ted Tredget, University of Alberta
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Ted Tredget, University of Alberta:

Primary Outcome Measures:
  • 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.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ted Tredget, Principal Investigator, University of Alberta
ClinicalTrials.gov Identifier: NCT00686478     History of Changes
Other Study ID Numbers: IFN - 1598
First Submitted: May 26, 2008
First Posted: May 29, 2008
Last Update Posted: January 30, 2014
Last Verified: January 2014

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

Additional relevant MeSH terms:
Hypertrophy
Cicatrix, Hypertrophic
Pathological Conditions, Anatomical
Cicatrix
Fibrosis
Pathologic Processes
Interferons
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs