Prospective, Randomized Half-side Study on the Efficacy of UVB-311nm Phototherapy in Patients With Psoriasis Undergoing Etanercept Treatment
Patients with moderate to severe psoriasis who have received a standard dose of etanercept
(50 mg or 25 mg s.c. twice weekly) for at least 6 weeks without a PASI reduction of 75% or
greater qualify for the study. Etanercept is continued and UVB-311nm phototherapy is added
at 6 weeks or thereafter on a randomized body half (left or right; head exempt) 3 x per week
until complete response (defined as reduction in PASI to < 3) for a maximum of another 6
weeks (until week 12). PASI score and patient disease score is assessed weekly; patient life
quality score at week 0, 6, and 12; all scores at follow-up visits at month 3, 6, and 12.
Paired statistical testing (T-test or Wilcoxon) for differences in PASI and patient disease
and life quality scores is done; Fischer exact test is applied to determine differences in
complete remission, PASI reduction > 90%, > 75%, and/or 50% between body sites.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Reduction of PASI (psoriasis activity score index)
prospective
No
Peter Wolf, MD
Principal Investigator
Dept. of Dermatology, Medical University of Graz, Graz, Austria
Austria: Federal Ministry for Health and Women
17-257 ex 05/06
NCT00550030
August 2006
December 2010
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