NCT00380640

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

11 months

First QC Date

September 25, 2006

Last Update Submit

April 17, 2018

Conditions

Epidermolysis Bullosa

Keywords

PediatricsEpidermolysis BullosaTrimethoprimWound Healing

Outcome Measures

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

    At 2 months, 3 months and 5 months after baseline visit

Secondary Outcomes (6)

  • Total number of blisters at each visit

    At 2 months, 3 months and 5 months after baseline visit

  • Total number of opened areas at each visit

    At 2 months, 3 months and 5 months after baseline visit

  • Qualitative wound score

    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

    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

    At 2 months, 3 months and 5 months after baseline visit

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: Trimethoprim

2

EXPERIMENTAL
Drug: Trimethoprim

Interventions

TrimethoprimDRUG

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

1

Eligibility Criteria

Age1 Day - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients younger than 20 years of age
  • Diagnosis of Recessive Dystrophic Epidermis Bullosa (RDEB)or Junctional Epidermis Bullosa (JEB)
  • Signed consent/assent form

You may not qualify if:

  • Previous known allergy or intolerance to trimethoprim

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Epidermolysis Bullosa

Interventions

Trimethoprim

Condition Hierarchy (Ancestors)

Skin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Vesiculobullous

Intervention Hierarchy (Ancestors)

PyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Elena Pope, MD

    The Hospital for Sick Children, Toronto Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

September 25, 2006

First Posted

September 26, 2006

Study Start

September 1, 2006

Primary Completion

August 1, 2007

Study Completion

September 1, 2007

Last Updated

April 19, 2018

Record last verified: 2018-04

Locations

CA(1)