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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356004
• Other study ID #: CairoU
• Status: Completed
• Phase: Phase 4
• First received: May 17, 2011
• Last updated: May 18, 2011
• Start date: January 2010
• Est. completion date: November 2010

Study information

• Verified date: January 2011
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with PASI score improvement as a Measure of effective treatment	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).	12 weeks	Yes
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		12 weeks	Yes