Effective Study of Live Attenuated Varicella Vaccine to Treat Severe Resistant Psoriasis
NCT ID: NCT01356004
Last Updated: 2011-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
35 participants
INTERVENTIONAL
2010-01-31
2010-11-30
Brief Summary
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The investigators hypothesized that the combined use of live attenuated varicella vaccine as an adjuvant therapy to low dose cyclosporine in the treatment of severe resistant psoriasis can give positive responses.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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chicken pox vaccine, efficacy
live attenuated chicken pox vaccine
Each immunizing dose was given subcutaneously (SC) in the form of 0.5 ml reconstituted vaccine which contains not less than 1033 plaque forming units (PFU) of the attenuated varicella-zoster-virus (VZV), which meets the World Health Organization (WHO) requirements for biological substances and for varicella vaccines. Doses were given 3 weeks apart for a total duration of 12 weeks (3 months).
saline, efficacy
saline, efficacy
4 doses of SC saline (0.5 ml) -as a placebo- in the same pattern as group A patients
Interventions
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live attenuated chicken pox vaccine
Each immunizing dose was given subcutaneously (SC) in the form of 0.5 ml reconstituted vaccine which contains not less than 1033 plaque forming units (PFU) of the attenuated varicella-zoster-virus (VZV), which meets the World Health Organization (WHO) requirements for biological substances and for varicella vaccines. Doses were given 3 weeks apart for a total duration of 12 weeks (3 months).
saline, efficacy
4 doses of SC saline (0.5 ml) -as a placebo- in the same pattern as group A patients
Eligibility Criteria
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Inclusion Criteria
* Resistance to conventional therapy (PUVA, methotrexate, retinoids):
(Maximum PASI 50% improvement while on treatment for a duration not less than 6 months).
* Immunologically competent individuals with
* Seropositive for the varicella antibodies
Exclusion Criteria
* Any contraindication to cyclosporine
18 Years
65 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Faculty of Medicine, Cairo University
Locations
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Cairo, , Egypt
Countries
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Other Identifiers
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CairoU
Identifier Type: -
Identifier Source: org_study_id
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