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Study to Evaluate the Efficacy of Tetracycline in Epidermolysis Bullosa

Primary Purpose

Epidermolysis Bullosa

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
tetracyclin
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epidermolysis Bullosa

Eligibility Criteria

13 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: diagnosed as epidermolysis bullosa not pregnant active disease more than 5 bulla- Exclusion Criteria: age less than 13 known sensitivity to tetracyclin abnormal liver and kidney tests.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    no of blisters

    Secondary Outcome Measures

    Full Information

    First Posted
    June 12, 2006
    Last Updated
    October 27, 2020
    Sponsor
    Rambam Health Care Campus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00336154
    Brief Title
    Study to Evaluate the Efficacy of Tetracycline in Epidermolysis Bullosa
    Official Title
    Randomised Double Blind Crossover Placebo Controlled Study to Evaluate the Efficacy of Tetracycline in Epidermolysis Bullosa
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    June 2006 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Rambam Health Care Campus

    4. Oversight

    5. Study Description

    Brief Summary
    Epidermolysis Bullosa(EB) is an inherited bullous disease. Tetracycline is believed to have anti inflammatory properties. 20 patients with EB older than 13 years will be treated for 4 months with tetracycline or placebo. After one month of wash out they will be treated for additional 4 m with placebo or tetracycline. The patients will be examined each month to estimate bulla formation,rate of healing .
    Detailed Description
    Epidermolysis Bullosa(EB) is an inherited bullous disease. Tetracycline is believed to have anti inflammatory properties. 20 patients with EB older than 13 years will be treated for 4 months with tetracycline or placebo. After one month of wash out they will be treated for additional 4 m with placebo or tetracycline. The patients will be examined each month to estimate bulla formation,rate of healing .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epidermolysis Bullosa

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    tetracyclin
    Primary Outcome Measure Information:
    Title
    no of blisters

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosed as epidermolysis bullosa not pregnant active disease more than 5 bulla- Exclusion Criteria: age less than 13 known sensitivity to tetracyclin abnormal liver and kidney tests.

    12. IPD Sharing Statement

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    Study to Evaluate the Efficacy of Tetracycline in Epidermolysis Bullosa

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