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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
10
This group will receive the active intervention (trimethoprim) first, followed by the placebo.
This group will start the study with placebo, followed by the active intervention (trimethoprim).
The Hospital for Sick Children
Toronto, Ontario, Canada
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
Time frame: At 2 months, 3 months and 5 months after baseline visit
Total number of blisters at each visit
Time frame: At 2 months, 3 months and 5 months after baseline visit
Total number of opened areas at each visit
Time frame: At 2 months, 3 months and 5 months after baseline visit
Qualitative wound score
Time frame: At 2 months, 3 months and 5 months after baseline visit
Parent/patient/physician perception of improvement, assessed with a visual analog scale at each visit
Time frame: At 2 months, 3 months and 5 months after baseline visit
Quality of life, assessed by the Children's Dermatology Life Quality Index (CDLQI) and the Cardiff Wound Impact Schedule
Time frame: At 2 months, 3 months and 5 months after baseline visit
Number of infections that require systemic antibiotics
Time frame: 6 months
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