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

May 18, 2011 updated by: Cairo University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with PASI score improvement as a Measure of effective treatment
Time Frame: 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).
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

May 17, 2011

First Submitted That Met QC Criteria

May 18, 2011

First Posted (Estimate)

May 19, 2011

Study Record Updates

Last Update Posted (Estimate)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 18, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CairoU (Other Identifier: University of Cairo)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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