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...
Date First Received: June 12, 2006
Last Updated: June 12, 2006
Verified by: Rambam Health Care Campus, June 2006
Clinical Trial Phase: Phase 4 | Start Date:
Overall Status: Not yet recruiting
Estimated Enrollment: 20
Brief Summary
Official Title: “Randomised Double Blind Crossover Placebo Controlled Study to Evaluate the Efficacy of Tetracycline in Epidermolysis Bullosa”
Condition Keyword(s):
Intervention(s):
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
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Detailed Clinical Trial 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 .
Intervention(s) in this Clinical Trial
- Drug: tetracyclin
Outcome Measures for this Clinical Trial
Primary Measures
- no of blisters
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 13 Years
Maximum Age for this Clinical Trial: 60 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Rambam Health Care Campus
Overall Clinical Trial Officials and Contacts
Eli Sprecher, professor Study Chair Dermatology depatment rambam health care campus
Overall Contact: Michal Ramon, Dr 972-4-542610 m_ramon@rambam.health.gov.il
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00336154
Study ID Number: 2140CTIL
ClinicalTrials.gov Identifier: NCT00336154
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
