Randomised Double Blind Crossover Placebo Controlled Study to Evaluate the Efficacy of Tetracycline in Epidermolysis Bullosa
Information source: Rambam Health Care Campus
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epidermolysis Bullosa
Intervention: tetracyclin (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Rambam Health Care Campus Official(s) and/or principal investigator(s):
Eli Sprecher, professor, Study Chair, Affiliation: Dermatology depatment rambam health care campus
Overall contact:
Michal Ramon, Dr, Phone: 972-4-542610, Email: m_ramon@rambam.health.gov.il
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 .
Clinical Details
Official title: Randomised Double Blind Crossover Placebo Controlled Study to Evaluate the Efficacy of Tetracycline in Epidermolysis Bullosa
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: no of blisters
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 .
Eligibility
Minimum age: 13 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
Michal Ramon, Dr, Phone: 972-4-542610, Email: m_ramon@rambam.health.gov.il
dermatology department Rambam health care campus, haifa 31096, Israel
dermatology department Rambam health care campus, haifa 31096, Israel
Additional Information
Last updated: June 12, 2006
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