Psoriasis
Conditions
Keywords
Psoriasis, Biologic, Ustekinumab, UVB-311nm narrowband, phototherapy, half-side comparison
Brief 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.
Interventions
RADIATIONUVB 311nm radiation
UVB-311nm radiation given 3 times a week to one randomized body-half
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Psoriasis patients who receive treatment with Ustekinumab
Exclusion criteria
* Age below 18 years * Pregnancy or lactation * History of malignant melanoma * History of invasive squamous cell carcinoma of the skin * Dysplastic melanocytic nevus syndrome * Antinuclear antibodies (ds-DNA, Ro/SSA, La/SSB) * Autoimmune disorders such as Lupus erythematosus or Dermatomyositis * Photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosum, basal cell nevus syndrome, and others * General poor health status
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified PASI (psoriasis area and severity index) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Patient visual analogue (VAS) score for therapeutic effect and severity of skin lesions | 12 months |
Countries
Austria
Outcome results
None listed