Psoriasis Clinical Trial
Official title:
Randomized Double-blind Phase 2 Study of Impact of Ultraviolet A (UVA) on Pruritus During Ultraviolet A/B (UVA/B) Phototherapy of Inflammatory Dermatoses
This is a double-blind prospective randomized monocenter study comparing the efficacy of two phototherapy ultraviolet spectra on pruritus (itching) of inflammatory skin diseases. 40 patients per treatment, in total 80 study participants.
In patients with a skin disease and the given indication for a phototherapy with Ultraviolet
B narrow-band (UVB narrowband, 311nm) with or without Ultraviolet A (UVA, 320-400 nm), the
subjective pruritus levels and clinical severity will be measured before, during and after
completion of the 16-week therapy (40 patients per group). Patients will be recruited in the
department of dermatology of the University Hospital Zürich in the outpatient clinic.
Following oral and written consent, pruritus levels will be measured by a visual analogue
scale and a new, detailed pruritus score 2 before start of therapy, every 4 weeks after
start as well as after completion of the phototherapy. Phototherapy is to be administered 3
times per week. The study includes 5 study visits and up to 43 treatment visits that include
administration of phototherapy only.
A physical examination including clinical scores (Psoriasis Area and Severity Index PASI,
Eczema Area and Severity Index EASI, Physician's static global assessment PSGA and
Dermatology Dynamics Vector DDV) will be performed at every visit. During the first physical
examination the Fitzpatrick-skin type of patient will be recorded, the demographics, the
Body Mass Index (BMI), diagnosis, past medical history, co-morbidities, concomitant
medication and the number of past UVA/B treatments.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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