An interventional study of UVB-311nm radiation and No treatment in Psoriasis, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-16.
Sponsored by Medical University of Graz · Not applicable, Interventional, and Treatment
Etanercept, a biological antipsoriatic drug with anti-tumor-necrosis factor (TNF) activity has been approved for the treatment of moderate to severe psoriasis. However, in a substantial portion of cases etanercept does not induce reduction in psoriasis area and severity index (PASI) of 75% or greater, now being considered as gold standard for treatment efficacy. In this study the researchers aim to determine in a randomized half-side comparison, whether additional narrowband UVB-311nm phototherapy accelerates and improves the therapeutic efficacy of etanercept.
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 6 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.
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Exclusion Criteria:
half-body comparison
Radiation: UVB-311nm radiation · Other: No treatment
UVB-311nm radiation randomized to one body half given 3 times a week for 6 weeks; the other body half remains UV-non-irradiated.
Also known as: Narrow band UVB radiation
no UV exposure
Reduction of PASI (psoriasis activity score index)
Time frame: prospective
Patient disease and life quality score
Time frame: prospective
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Medical University of Graz