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

Phase 4

Completed

• Conditions: Psoriasis
• Interventions: Drug: live attenuated chicken pox vaccine; Drug: saline, efficacy

• Registration Number: NCT01356004
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-05
• Study Completion: 2010-11
• Status Verified: 2011-01
• Study First Submitted: 2011-05-17
• Study First Submitted QC: 2011-05-18
• Last Update Submitted: 2011-05-18
• Study First Posted: 2011-05-19
• Last Update Posted: 2011-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chicken pox vaccine, efficacy	live attenuated chicken pox vaccine	-
saline, efficacy	saline, efficacy	-

Primary Outcome Measures

Name	Time	Method
Number of Participants with PASI score improvement as a Measure of effective treatment	12 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	12 weeks