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

Sponsor:	Rambam Health Care Campus
Information provided by:	Rambam Health Care Campus
ClinicalTrials.gov Identifier:	NCT00336154

Purpose

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 .

Condition	Intervention	Phase
Epidermolysis Bullosa	Drug: tetracyclin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Randomised Double Blind Crossover Placebo Controlled Study to Evaluate the Efficacy of Tetracycline in Epidermolysis Bullosa

Resource links provided by NLM:

Genetics Home Reference related topics: epidermolysis bullosa simplex epidermolysis bullosa with pyloric atresia junctional epidermolysis bullosa

Drug Information available for: Tetracycline Tetracycline hydrochloride

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:

no of blisters

Estimated Enrollment:

20

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

Ages Eligible for Study:	13 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336154

Contacts

Contact: Michal Ramon, Dr	972-4-542610	m_ramon@rambam.health.gov.il
Contact: Eli Sprecher, Prof	972-4-541919	e_sprecher@rambam.health.gov.il

Locations

Israel
dermatology department Rambam health care campus
Haifa, Israel, 31096

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

Study Chair:

Eli Sprecher, professor

Dermatology depatment rambam health care campus

More Information

No publications provided

Study ID Numbers:	2140CTIL
Study First Received:	June 12, 2006
Last Updated:	June 12, 2006
ClinicalTrials.gov Identifier:	NCT00336154 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Skin Diseases
Skin Diseases, Vesiculobullous
Molecular Mechanisms of Pharmacological Action
Skin Abnormalities
Enzyme Inhibitors
Epidermolysis Bullosa
Tetracycline

Pharmacologic Actions
Protein Synthesis Inhibitors
Anti-Bacterial Agents
Genetic Diseases, Inborn
Therapeutic Uses
Congenital Abnormalities
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on March 18, 2010