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
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
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.
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
Total number of blisters at each visit
Total 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
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.
Minimum age: N/A.
Maximum age: 20 Years.
- Patients younger than 20 years of age
- Diagnosis of Recessive Dystrophic Epidermis Bullosa (RDEB)or Junctional Epidermis
- Signed consent/assent form
- Previous known allergy or intolerance to trimethoprim
Locations and Contacts
The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada
Starting date: September 2006
Ending date: September 2007
Last updated: May 22, 2008