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

Phase 2

Completed

• Conditions: Epidermolysis Bullosa
• Interventions: Drug: Trimethoprim

• Registration Number: NCT00380640
• Lead Sponsor: The Hospital for Sick Children

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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-25
• Study First Submitted QC: 2006-09-25
• Study First Posted: 2006-09-26
• Primary Completion: 2007-08
• Study Completion: 2007-09
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Trimethoprim	-
2	Trimethoprim	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Qualitative wound score	At 2 months, 3 months and 5 months after baseline visit
Number of infections that require systemic antibiotics	6 months
Total number of blisters at each visit	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
Total number of opened areas 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

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada