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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01356004

Enrollment

Registered

2011-05-19

Start date

2010-01-31

Completion date

2010-11-30

Last updated

2011-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

severe resistant

Brief summary

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.

Interventions

DRUGlive 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).

DRUGsaline, efficacy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with PASI score improvement as a Measure of effective treatment	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

Measure	Time frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	12 weeks

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026