Study to Evaluate the Efficacy of Tetracycline in Epidermolysis Bullosa

October 27, 2020 updated by: Rambam Health Care Campus

Randomised Double Blind Crossover Placebo Controlled Study to Evaluate the Efficacy of Tetracycline in Epidermolysis Bullosa

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 .

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
no of blisters

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

June 1, 2006

Study Registration Dates

First Submitted

June 12, 2006

First Submitted That Met QC Criteria

June 12, 2006

First Posted (Estimate)

June 13, 2006

Study Record Updates

Last Update Posted (Actual)

October 28, 2020

Last Update Submitted That Met QC Criteria

October 27, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2140CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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