Clinical trial NCT00380640: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epidermolysis Bullosa
Keywords: Pediatrics
Epidermolysis Bullosa
Trimethoprim
Wound Healing
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2006-09-26
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: At 2 months, 3 months and 5 months after baseline visit
Secondary outcomes:
measure: Total number of blisters at each visit
timeFrame: At 2 months, 3 months and 5 months after baseline visit
measure: Total number of opened areas at each visit
timeFrame: At 2 months, 3 months and 5 months after baseline visit
measure: Qualitative wound score
timeFrame: At 2 months, 3 months and 5 months after baseline visit
measure: Parent/patient/physician perception of improvement, assessed with a visual analog scale at each visit
timeFrame: At 2 months, 3 months and 5 months after baseline visit
measure: Quality of life, assessed by the Children's Dermatology Life Quality Index (CDLQI) and the Cardiff Wound Impact Schedule
timeFrame: At 2 months, 3 months and 5 months after baseline visit
measure: Number of infections that require systemic antibiotics
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Elena Pope, MD
role: PRINCIPAL_INVESTIGATOR
References: