Epidermolysis Bullosa
Conditions
Keywords
Pediatrics, Epidermolysis Bullosa, Trimethoprim, Wound Healing
Brief 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.
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.
Interventions
DRUGTrimethoprim
This group will receive the active intervention (trimethoprim) first, followed by the placebo.
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Days to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | At 2 months, 3 months and 5 months after baseline visit |
Secondary
| Measure | Time frame |
|---|---|
| Total number of opened areas at each visit | At 2 months, 3 months and 5 months after baseline visit |
| Qualitative wound score | At 2 months, 3 months and 5 months after baseline visit |
| Total number of blisters at each visit | 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 | At 2 months, 3 months and 5 months after baseline visit |
| Number of infections that require systemic antibiotics | 6 months |
| Parent/patient/physician perception of improvement, assessed with a visual analog scale at each visit | At 2 months, 3 months and 5 months after baseline visit |
Countries
Canada
Outcome results
None listed