Effective Study of Live Attenuated Varicella Vaccine to Treat Severe Resistant Psoriasis
|ClinicalTrials.gov Identifier: NCT01356004|
Recruitment Status : Completed
First Posted : May 19, 2011
Last Update Posted : May 19, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: live attenuated chicken pox vaccine Drug: saline, efficacy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Live Attenuated Varicella Vaccine: A New Effective Adjuvant Weapon in the Battlefield Against Severe Resistant Psoriasis, a Randomized Controlled Trial|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||November 2010|
|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
- 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).
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356004