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Study to Evaluate the Efficacy of Tetracycline in Epidermolysis Bullosa

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ClinicalTrials.gov Identifier: NCT00336154
Recruitment Status : Withdrawn
First Posted : June 13, 2006
Last Update Posted : October 28, 2020
Sponsor:
Information provided by:
Rambam Health Care Campus

Study Description
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Brief 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 .

Condition or disease Intervention/treatment Phase
Epidermolysis Bullosa Drug: tetracyclin Phase 4

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 .
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Estimated Primary Completion Date : June 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. no of blisters

Eligibility Criteria
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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
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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ClinicalTrials.gov Identifier: NCT00336154    
Other Study ID Numbers: 2140CTIL
First Posted: June 13, 2006    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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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