Back to resultsEffective Study of Live Attenuated Varicella Vaccine to Treat Severe Resistant Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
live attenuated chicken pox vaccine
saline, efficacy
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring severe resistant
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
chicken pox vaccine, efficacy
saline, efficacy
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01356004
Brief Title
Effective Study of Live Attenuated Varicella Vaccine to Treat Severe Resistant Psoriasis
Official Title
Live Attenuated Varicella Vaccine: A New Effective Adjuvant Weapon in the Battlefield Against Severe Resistant Psoriasis, a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
severe resistant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
chicken pox vaccine, efficacy
Arm Type
Experimental
Arm Title
saline, efficacy
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
live attenuated chicken pox vaccine
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
saline, efficacy
Intervention Description
4 doses of SC saline (0.5 ml) -as a placebo- in the same pattern as group A patients
Primary Outcome Measure Information:
Title
Number of Participants with PASI score improvement as a Measure of effective treatment
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Effective Study of Live Attenuated Varicella Vaccine to Treat Severe Resistant Psoriasis
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