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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00380640
• Date of registration: 25/09/2006
• Prospective Registration: No
• Primary sponsor: The Hospital for Sick Children
• Public title: The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa
• Scientific title: The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa: A Randomized, Double Blinded, Placebo Controlled, Cross-over Pilot Study
• Date of first enrolment: September 2006
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00380640
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Elena Pope, MD
• Affiliation: The Hospital for Sick Children, Toronto Canada

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 20 Years
Gender: All

Health Condition(s) or Problem(s) studied

Epidermolysis Bullosa

Intervention(s)

Drug: Trimethoprim

Primary Outcome(s)

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 Outcome(s)

Number of infections that require systemic antibiotics [Time Frame: 6 months]

Qualitative wound score [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]

Total number of blisters at each visit [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]

Total number of opened areas at each visit [Time Frame: At 2 months, 3 months and 5 months after baseline visit]

Secondary ID(s)

1000009064

Source(s) of Monetary Support

Please refer to primary and secondary sponsors