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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2006 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00336154
First Posted: June 13, 2006
Last Update Posted: June 13, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rambam Health Care Campus
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Not yet recruiting
Haifa, Israel, 31096
Contact: Michal Ramon, MD    972-4-8542610    m_ramon@rambam.health.gov.il   
Principal Investigator: Michal Ramon, MD         
dermatology department Rambam health care campus Not yet recruiting
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Study Chair: Eli Sprecher, professor Dermatology depatment rambam health care campus
  More Information

ClinicalTrials.gov Identifier: NCT00336154     History of Changes
Other Study ID Numbers: 2140CTIL
First Submitted: June 12, 2006
First Posted: June 13, 2006
Last Update Posted: June 13, 2006
Last Verified: June 2006

Additional relevant MeSH terms:
Epidermolysis Bullosa
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Vesiculobullous
Tetracycline
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action