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NCT Number: NCT01356004

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

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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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

live attenuated chicken pox vaccine

Drug

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).

saline, efficacy

Drug

4 doses of SC saline (0.5 ml) -as a placebo- in the same pattern as group A patients

Primary outcomes

  1. 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).

Secondary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Live Attenuated Varicella Vaccine: A New Effective Adjuvant Weapon in the Battlefield Against Severe Resistant Psoriasis, a Randomized Controlled Trial

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 19, 2011
Registry last updated
May 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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