NCT00870285

Ustekinumab Plus UVB-311nm in Psoriasis

Ustekinumab Plus UVB-311nm Half-side Phototherapy in Patients With Psoriasis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Ustekinumab, an IL-12/23 antibody has been approved in the E.C. and U.S.A. for the treatment of moderate to severe psoriasis. The aim of this study is to determine in a randomized half-side comparison whether additional narrowband UVB-311nm phototherapy accelerates and improves the clearance of skin lesions in Ustekinumab-treated patients.

Detailed description

Patients with moderate to severe psoriasis who receive standard treatment with Ustekinumab (45 mg at week 0, 4, and every 12 weeks) are exposed to UVB-311nm phototherapy on a randomized body half (left or right; head exempt) 3 x per week for six weeks and/or until complete response (defined as reduction in PASI to \< 3). PASI score, patient visual analogue score (VAS) for therapeutic response, and patient VAS for severity of skin lesions is assessed weekly; and at follow-up visits at month 3, 6, and 12. Paired Wilcoxon testing for differences in PASI and patient VAS scores is done; Fischer exact test is applied to determine differences in complete remission, PASI reduction \> 90%, \> 75% and/or 50% between body sites.

Conditions

• Psoriasis

Interventions

Type	Name	Description
RADIATION	UVB 311nm radiation	UVB-311nm radiation given 3 times a week to one randomized body-half

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2009-03-27
• Last updated: 2012-03-16

Locations

1 site across 1 country: Austria