Intron A for the Treatment of Hypertrophic Scar

NCT00686478 | Withdrawn Phase 3

• 1 other identifier: IFN - 1598
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn; Hypertrophic Scar

Keywords

burn; hypertrophic scar; fibroproliferative disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

interferon alpha 2b (Intron A)

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo administered subcutaneously once a day for 7 days, then three times a week for 23 weeks.

Drug: interferon alpha 2b

Interventions

interferon alpha 2b DRUG

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.

Also known as: intron a

Placebo; interferon alpha 2b (Intron A)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• burns \> 5% tbsa
• informed consent
• no prior exposure to interferon or other cytokines

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Burns; Cicatrix, Hypertrophic

Interventions

Interferon alpha-2; Introns

Condition Hierarchy (Ancestors)

Wounds and Injuries; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes

Study Officials

• Edward E Tredget, MD MSc FRCSC

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2008
• First Posted: May 29, 2008
• Last Updated: January 30, 2014

Record last verified: 2014-01

Locations

CA (1)