The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa
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|ClinicalTrials.gov Identifier: NCT00380640|
Recruitment Status : Completed
First Posted : September 26, 2006
Last Update Posted : April 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Epidermolysis Bullosa||Drug: Trimethoprim||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Start Date :||September 2006|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||September 2007|
This group will receive the active intervention (trimethoprim) first, followed by the placebo.
This group will start the study with placebo, followed by the active intervention (trimethoprim).
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00380640
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Elena Pope, MD||The Hospital for Sick Children, Toronto Canada|