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

Information source: Rambam Health Care Campus
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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; Not yet recruiting
Michal Ramon, MD, Phone: 972-4-8542610, Email: m_ramon@rambam.health.gov.il
Michal Ramon, MD, Principal Investigator

dermatology department Rambam health care campus, Haifa 31096, Israel; Not yet recruiting

Additional Information


Last updated: June 12, 2006

Page last updated: August 23, 2015

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