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

This study has been completed.
Sponsor:
Information provided by:
Cairo University
ClinicalTrials.gov Identifier:
NCT01356004
First received: May 17, 2011
Last updated: May 18, 2011
Last verified: January 2011

May 17, 2011
May 18, 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 ] [ Designated as safety issue: Yes ]

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
Complete list of historical versions of study NCT01356004 on ClinicalTrials.gov Archive Site
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Psoriasis
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT01356004
CairoU
Yes
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