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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
Sponsor:
Information provided by (Responsible Party):
Elena Pope, The Hospital for Sick Children

Study Description
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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.

Condition or disease Intervention/treatment Phase
Epidermolysis Bullosa Drug: Trimethoprim Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: Trimethoprim
This group will receive the active intervention (trimethoprim) first, followed by the placebo.
Experimental: 2 Drug: Trimethoprim
This group will start the study with placebo, followed by the active intervention (trimethoprim).


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Total number of blisters at each visit [ Time Frame: At 2 months, 3 months and 5 months after baseline visit ]
  2. Total number of opened areas at each visit [ Time Frame: At 2 months, 3 months and 5 months after baseline visit ]
  3. Qualitative wound score [ Time Frame: At 2 months, 3 months and 5 months after baseline visit ]
  4. 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 ]
  5. 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 ]
  6. Number of infections that require systemic antibiotics [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Elena Pope, MD The Hospital for Sick Children, Toronto Canada
More Information
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Additional Information:

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Responsible Party: Elena Pope, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00380640    
Other Study ID Numbers: 1000009064
First Posted: September 26, 2006    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Keywords provided by Elena Pope, The Hospital for Sick Children:
Pediatrics
Epidermolysis Bullosa
Trimethoprim
Wound Healing
Additional relevant MeSH terms:
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Epidermolysis Bullosa
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Vesiculobullous
Trimethoprim
Anti-Infective Agents, Urinary
Anti-Infective Agents
 Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors