The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa
Information source: The Hospital for Sick Children
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epidermolysis Bullosa
Intervention: Trimethoprim (Drug); Trimethoprim (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: The Hospital for Sick Children Official(s) and/or principal investigator(s):
Elena Pope, MD, Principal Investigator, Affiliation: The Hospital for Sick Children, Toronto Canada
Summary
The purpose of this study is to assess the efficacy of trimethoprim in promoting wound
healing and decreasing blister formation in patients with Epidermolysis Bullosa.
Clinical Details
Official title: The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa: A Randomized, Double Blinded, Placebo Controlled, Cross-Over Pilot Study
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Percentage change of area of the wound from visit to visit, estimated from the longest length and width of up to three target chronic wounds
Secondary outcome: Total number of blisters at each visitTotal number of opened areas at each visit Qualitative wound score Parent/patient/physician perception of improvement, assessed with a visual analog scale at each visit Quality of life, assessed by the Children's Dermatology Life Quality Index (CDLQI) and the Cardiff Wound Impact Schedule Number of infections that require systemic antibiotics
Detailed description:
Epidermolysis Bullosa (EB) comprises a series of hereditary disorders characterized by
fragility of the skin and mucous membranes and the tendency of the skin to blister in
response to minor friction or trauma. The care of patients with EB is a complex task that has
to be carried out by a multi-professional team. In the absence of a cure, the goal of
therapy is the prevention and healing of chronic wounds.
In patients with EB, chronic inflammation interferes with proper wound healing. One treatment
option is the use of anti-inflammatory antimicrobial agents, such as trimethoprim, to hasten
wound healing and decrease blister formation. This treatment may lead to decreased pain and
improvement of the quality of life for these patients.
Eligibility
Minimum age: N/A.
Maximum age: 20 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients younger than 20 years of age
- Diagnosis of Recessive Dystrophic Epidermis Bullosa (RDEB)or Junctional Epidermis
Bullosa (JEB)
- Signed consent/assent form
Exclusion Criteria:
- Previous known allergy or intolerance to trimethoprim
Locations and Contacts
The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada
Additional Information
Starting date: September 2006
Ending date: September 2007
Last updated: May 22, 2008
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