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

Primary Purpose

Epidermolysis Bullosa

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Trimethoprim

About this trial

This is an interventional treatment trial for Epidermolysis Bullosa focused on measuring Pediatrics, Epidermolysis Bullosa, Trimethoprim, Wound Healing

Eligibility Criteria

1 Day - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total number of blisters at each visit

Total number of opened areas at each visit

Qualitative wound score

Parent/patient/physician perception of improvement, assessed with a visual analog scale at each visit

Quality of life, assessed by the Children's Dermatology Life Quality Index (CDLQI) and the Cardiff Wound Impact Schedule

Number of infections that require systemic antibiotics

Full Information

NCT ID

NCT00380640

First Posted

September 25, 2006

Last Updated

April 17, 2018

Sponsor

The Hospital for Sick Children

1. Study Identification

Unique Protocol Identification Number

NCT00380640

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hospital for Sick Children

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epidermolysis Bullosa

Keywords

Pediatrics, Epidermolysis Bullosa, Trimethoprim, Wound Healing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Trimethoprim

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Trimethoprim

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame