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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elena Pope, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00380640
First received: September 25, 2006
Last updated: August 1, 2013
Last verified: August 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Staff Physician, 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: August 1, 2013
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 July 23, 2014