Efficacy Study of Two Choices of Phototherapy on Itching Skin Diseases

Phase 2

Completed

• Conditions: Eczema; Psoriasis
• Interventions: Device: UVB phototherapy; Device: UVA / UVB phototherapy

• Registration Number: NCT01254240
• Lead Sponsor: University of Zurich

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-02
• Study First Submitted QC: 2010-12-03
• Study First Posted: 2010-12-06
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UVB phototherapy treatment	UVB phototherapy	UVB phototherapy units, stand alone cabins, patients undress, step in the cabin and receive treatment in a duration of seconds to minutes. The noticable difference between the UVA/B and UVB treatment is only in the settings of the cabin.
UVA/B phototherapy treatment	UVA / UVB phototherapy	UVA/B phototherapy units, stand alone cabins, patients undress, step in the cabin and receive treatment in a duration of seconds to minutes. The noticable difference between the UVA/B and UVB treatment is only in the settings of the cabin.

Primary Outcome Measures

Name	Time	Method
5-D Pruritus score and VAS Score at 16 weeks	16 weeks

Trial Locations

Locations (1)

University Hospital Zurich, Department of Dermatology; 🇨🇭 Zurich, Switzerland