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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2007

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.

Interventions

  • 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).

Arms, Groups and Cohorts

  • Experimental: 1
  • Experimental: 2

Clinical Trial Outcome Measures

Primary 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
    • Time Frame: At 2 months, 3 months and 5 months after baseline visit

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 20 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Hospital for Sick Children
  • Provider of Information About this Clinical Study
    • Principal Investigator: Elena Pope, Staff Physician – The Hospital for Sick Children
  • Overall Official(s)
    • Elena Pope, MD, Principal Investigator, The Hospital for Sick Children, Toronto Canada

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