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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trimethoprim | Drug | This group will receive the active intervention (trimethoprim) first, followed by the placebo. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
-Previous known allergy or intolerance to trimethoprim
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| Name | Affiliation | Role |
|---|---|---|
| Elena Pope, MD | The Hospital for Sick Children, Toronto Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
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| ID | Term |
|---|---|
| D004820 | Epidermolysis Bullosa |
| ID | Term |
|---|---|
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
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| ID | Term |
|---|---|
| D014295 | Trimethoprim |
| ID | Term |
|---|---|
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Trimethoprim | Drug | This group will start the study with placebo, followed by the active intervention (trimethoprim). |
|
| 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 |
| D030342 | Genetic Diseases, Inborn |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012872 | Skin Diseases, Vesiculobullous |