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

NCT ID: NCT00380640

Last Updated: 2018-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2007-09-30

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.

Conditions

Epidermolysis Bullosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

Trimethoprim

Intervention Type: DRUG

This group will receive the active intervention (trimethoprim) first, followed by the placebo.

2

Group Type: EXPERIMENTAL

Trimethoprim

Intervention Type: DRUG

This group will start the study with placebo, followed by the active intervention (trimethoprim).

Interventions

Trimethoprim

This group will receive the active intervention (trimethoprim) first, followed by the placebo.

Intervention Type: DRUG

Trimethoprim

This group will start the study with placebo, followed by the active intervention (trimethoprim).

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Elena Pope

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elena Pope, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000009064

Identifier Type: -

Identifier Source: org_study_id