The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa
This study has been completed.
Sponsor:
The Hospital for Sick Children
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00380640
First received: September 25, 2006
Last updated: May 22, 2008
Last verified: May 2008
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Epidermolysis Bullosa |
Drug: Trimethoprim |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
epidermolysis bullosa simplex
epidermolysis bullosa with pyloric atresia
junctional epidermolysis bullosa
U.S. FDA Resources
Further study details as provided by The Hospital for Sick Children:
Primary Outcome 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Total number of blisters at each visit [ Time Frame: At 2 months, 3 months and 5 months after baseline visit ] [ Designated as safety issue: No ]
- Total number of opened areas at each visit [ Time Frame: At 2 months, 3 months and 5 months after baseline visit ] [ Designated as safety issue: No ]
- Qualitative wound score [ Time Frame: At 2 months, 3 months and 5 months after baseline visit ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Number of infections that require systemic antibiotics [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | September 2006 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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).
|
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| Ages Eligible for Study: | up to 20 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00380640
Locations
| Canada, Ontario | |
| The Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
| Principal Investigator: | Elena Pope, MD | The Hospital for Sick Children, Toronto Canada |
More Information
No publications provided
| Responsible Party: | Elena Pope/Principal Investigator, The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT00380640 History of Changes |
| Other Study ID Numbers: | 1000009064 |
| Study First Received: | September 25, 2006 |
| Last Updated: | May 22, 2008 |
| Health Authority: | Canada: Health Canada |
Keywords provided by The Hospital for Sick Children:
|
Pediatrics Epidermolysis Bullosa Trimethoprim Wound Healing |
Additional relevant MeSH terms:
|
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 |
Therapeutic Uses Pharmacologic Actions Renal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013