The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa: A Randomized, Double Blinded, Placebo Controlled, Cross-over Pilot Study

Conditions
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Epidermolysis Bullosa

Intervention / Treatment
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* Drug: Trimethoprim
* Drug: Trimethoprim


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Trimethoprim<br>* This group will receive the active intervention (trimethoprim) first, followed by the placebo.<br>|
| Experimental: 2<br> | Drug: Trimethoprim<br>* This group will start the study with placebo, followed by the active intervention (trimethoprim).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of blisters at each visit |  | At 2 months, 3 months and 5 months after baseline visit | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatrics, Epidermolysis Bullosa, Trimethoprim, Wound Healing