Effective Study of Live Attenuated Varicella Vaccine to Treat Severe Resistant Psoriasis

Study Overview
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Brief Summary
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Immunotherapy was reported in the treatment of psoriasis. Treatment of resistant psoriasis may be difficult and cyclosporine can induce some remission. 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.

Official Title
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Live Attenuated Varicella Vaccine: A New Effective Adjuvant Weapon in the Battlefield Against Severe Resistant Psoriasis, a Randomized Controlled Trial

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: live attenuated chicken pox vaccine
* Drug: saline, efficacy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe psoriasis: At least 30% of body involved) according to the rule of nine. 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 live attenuated varicella vaccine Any contraindication to cyclosporine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chicken pox vaccine, efficacy<br> | Drug: live attenuated chicken pox vaccine<br>* 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).<br>|
| Placebo Comparator: saline, efficacy<br> | Drug: saline, efficacy<br>* 4 doses of SC saline (0.5 ml) -as a placebo- in the same pattern as group A patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with PASI score improvement as a Measure of effective treatment | the clinical evaluation of our patients through the Psoriasis Area Severity Index (PASI) score calculation at each visit. The final patient's response was rated according to the physician global assessment (PGA) based on the final improvement of the PASI score as worse, poor (0-24% improvement in PASI), fair (25-50% improvement in PASI), good (50-74% improvement in PASI), excellent (75-99% improvement in PASI), or cleared (100% improvement in PASI). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe resistant