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...
Brief Summary
Official Title: “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 Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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 Investigator Information
Lead Investigator: Rambam Health Care Campus Other
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 February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00336154
