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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01356004
Recruitment Status : Completed
First Posted : May 19, 2011
Last Update Posted : May 19, 2011
Information provided by:
Cairo University

May 17, 2011
May 19, 2011
May 19, 2011
January 2010
May 2010   (Final data collection date for primary outcome measure)
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).

Same as current
No Changes Posted
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 weeks ]
Same as current
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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

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.

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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • 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).
  • Drug: saline, efficacy
    4 doses of SC saline (0.5 ml) -as a placebo- in the same pattern as group A patients
  • Experimental: chicken pox vaccine, efficacy
    Intervention: Drug: live attenuated chicken pox vaccine
  • Placebo Comparator: saline, efficacy
    Intervention: Drug: saline, efficacy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2010
May 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Prof. Mohammad El Darouti, Faculty of Medicine, Cairo University
Cairo University
Not Provided
Not Provided
Cairo University
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP