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

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

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.

Study Overview

• Status: Completed
• Conditions: Epidermolysis Bullosa
• Intervention / Treatment: Drug: Trimethoprim; Drug: Trimethoprim

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Trimethoprim; This group will receive the active intervention (trimethoprim) first, followed by the placebo.; Drug: Trimethoprim; This group will start the study with placebo, followed by the active intervention (trimethoprim).
Experimental: 2	Drug: Trimethoprim; This group will receive the active intervention (trimethoprim) first, followed by the placebo.; Drug: Trimethoprim; This group will start the study with placebo, followed by the active intervention (trimethoprim).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Elena Pope, MD, The Hospital for Sick Children, Toronto Canada

Publications and helpful links

Helpful Links

• please see published results using the link

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: September 25, 2006
• First Submitted That Met QC Criteria: September 25, 2006
• First Posted (Estimate): September 26, 2006

Study Record Updates

• Last Update Posted (Actual): April 19, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Wound Healing; Pediatrics; Epidermolysis Bullosa; Trimethoprim
• Additional Relevant MeSH Terms: Skin Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Skin Diseases, Genetic; Skin Diseases, Vesiculobullous; Skin Abnormalities; Epidermolysis Bullosa; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Anti-Dyskinesia Agents; Anti-Infective Agents, Urinary; Renal Agents; Cytochrome P-450 CYP2C8 Inhibitors; Trimethoprim
• Other Study ID Numbers: 1000009064