Effective Study of Live Attenuated Varicella Vaccine to Treat Severe Resistant Psoriasis
Live Attenuated Varicella Vaccine: A New Effective Adjuvant Weapon in the Battlefield Against Severe Resistant Psoriasis, a Randomized Controlled Trial
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 17, 2011
CompletedFirst Posted
Study publicly available on registry
May 19, 2011
CompletedMay 19, 2011
January 1, 2011
4 months
May 17, 2011
May 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
12 weeks
Study Arms (2)
chicken pox vaccine, efficacy
EXPERIMENTALsaline, efficacy
PLACEBO COMPARATORInterventions
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).
4 doses of SC saline (0.5 ml) -as a placebo- in the same pattern as group A patients
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any contraindication to live attenuated varicella vaccine
- Any contraindication to cyclosporine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Unknown Facility
Cairo, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 17, 2011
First Posted
May 19, 2011
Study Start
January 1, 2010
Primary Completion
May 1, 2010
Study Completion
November 1, 2010
Last Updated
May 19, 2011
Record last verified: 2011-01