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NCT00336154 Clinical Trial

Study to Evaluate the Efficacy of Tetracycline in Epidermolysis Bullosa

Epidermolysis Bullosa Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00336154
Other study ID # 2140CTIL
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated

Study information
Verified date October 2020
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .

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 .

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender All
Age group 13 Years to 60 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• tetracyclin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Outcome
Type Measure Description Time frame Safety issue
Primary no of blisters
See also
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Completed NCT01716169 - Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care N/A
Withdrawn NCT01454687 - Grafting of Epidermolysis Bullosa Wounds Using Cultured Revertant Autologous Keratinocytes N/A
Completed NCT00014729 - Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa Phase 1
Recruiting NCT05838092 - Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III) Phase 3
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Terminated NCT02090283 - Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa Phase 2
Completed NCT02582775 - MT2015-20: Biochemical Correction of Severe EB by Allo HSCT and Serial Donor MSCs Phase 2
Recruiting NCT04213703 - A Pilot Study to Explore the Role of Gut Flora in Epidermolysis Bullosa
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Terminated NCT02670330 - Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa Phase 3
Terminated NCT01619670 - A Observational Study to Evaluate Apligraf(R) in Nonhealing Wounds of Subjects With Epidermolysis Bullosa Phase 4
Recruiting NCT01340235 - Treatment of Dowling Maera Type of Epidermolysis Bullosa Simplex by Oral Erythromycin Phase 3
Completed NCT02014376 - Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa Phase 2
Completed NCT04217538 - Observational Study of a Cohort of Patients With Hereditary Epidermolysis Bullosa
Completed NCT03942250 - Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients N/A
Completed NCT01033552 - Biochemical Correction of Severe EB by Allo HSCT and "Off-the-shelf" MSCs Phase 1/Phase 2