Intron A for the Treatment of Hypertrophic Scar - Full Text View

Sponsored by:	University of Alberta
Information provided by:	University of Alberta
ClinicalTrials.gov Identifier:	NCT00686478

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, bloodwork, 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 treatmetn period.

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

MedlinePlus related topics: Burns Scars

Drug Information available for: Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment
Official Title:	A Double-Blind Placebo Controlled Trial Using Subcutaneous Injections of Intron A for the Treatment of Hypertrophic Scar

Further study details as provided by University of Alberta:

Primary Outcome Measures:

Time [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	June 1994
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Intron A	Drug: interferon alpha 2b subcutaneous injection of 1 million units of interferon alpha 2b, 3 times per week for 6 months
2: Placebo Comparator vehicle	Drug: placebo placebo

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

Responsible Party:	University of Alberta ( Edward E Tredget MD, MSc, FRCSC )
Study ID Numbers:	IFN - 1598
Study First Received:	May 26, 2008
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00686478
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University of Alberta:

burn
hypertrophic scar
fibroproliferative disorder

Study placed in the following topic categories:

Interferon-alpha
Pathological Conditions, Anatomical
Burns
Hypertrophy
Cicatrix, Hypertrophic

Skin Diseases
Interferons
Interferon Alfa-2a
Interferon Alfa-2b
Cicatrix

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs

Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009