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
  Purpose

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 Intervention Phase
Psoriasis
Drug: live attenuated chicken pox vaccine
Drug: saline, efficacy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Live Attenuated Varicella Vaccine: A New Effective Adjuvant Weapon in the Battlefield Against Severe Resistant Psoriasis, a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • 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).



Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: January 2010
Study Completion Date: November 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356004

Locations
Egypt
Cairo, Egypt
Sponsors and Collaborators
Cairo University
  More Information

No publications provided

Responsible Party: Prof. Mohammad El Darouti, Faculty of Medicine, Cairo University
ClinicalTrials.gov Identifier: NCT01356004     History of Changes
Other Study ID Numbers: CairoU
Study First Received: May 17, 2011
Last Updated: May 18, 2011
Health Authority: Egypt: Institutional Review Board

Keywords provided by Cairo University:
severe resistant

Additional relevant MeSH terms:
Chickenpox
Psoriasis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 28, 2014