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

Epidermolysis Bullosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00380640
• Other study ID #: 1000009064
• Status: Completed
• Phase: Phase 2
• First received: September 25, 2006
• Last updated: April 17, 2018
• Start date: September 2006
• Est. completion date: September 2007

Study information

• Verified date: April 2018
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Epidermolysis Bullosa

Intervention

Drug:
• Trimethoprim
This group will receive the active intervention (trimethoprim) first, followed by the placebo.
• Trimethoprim
This group will start the study with placebo, followed by the active intervention (trimethoprim).

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total number of blisters at each visit		At 2 months, 3 months and 5 months after baseline visit
Secondary	Total number of opened areas at each visit		At 2 months, 3 months and 5 months after baseline visit
Secondary	Qualitative wound score		At 2 months, 3 months and 5 months after baseline visit
Secondary	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
Secondary	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
Secondary	Number of infections that require systemic antibiotics		6 months

External Links

•   please see published results using the link