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Completed

NCT Number: NCT00380640

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

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.

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Key information

Conditions

Epidermolysis Bullosa Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

1 day–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trimethoprim

Drug

This group will receive the active intervention (trimethoprim) first, followed by the placebo.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa: A Randomized, Double Blinded, Placebo Controlled, Cross-over Pilot Study

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 26, 2006
Registry last updated
Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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