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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Rambam Health Care Campus.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00336154
First received: June 12, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
  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
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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

No publications provided

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

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
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014