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Completed

NCT Number: NCT01254240

Efficacy Study of Two Choices of Phototherapy on Itching Skin Diseases

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Zurich, Department of Dermatology

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pruritic inflammatory diseases such as atopic dermatitis, other types of eczema, psoriasis, prurigo simplex subacuta and others.

Main inclusion criteria:

  • Pruritus VAS Score 5 or higher at screening.
  • Dermatological indication for a phototherapy with UVB nb / UVA
  • Oral and written informed patient consent

Exclusion criteria

  • Patients will be excluded from the study if they fulfill any of the following criteria:
  • Foreseeable interruption of the light therapy for more than 14 days, or interruption of the light therapy for more than 14 days during the study
  • Heightened photosensitivity for UVA or UVB
  • Withdrawal of consent to participate
  • Concomitant participation in another study or having taken part in another clinical study within the last 30 days.

Treatment and study plan

UVA / UVB phototherapy

Device

UVA / UVB phototherapy

Other names: Waldmann phototherapy cabins

UVB phototherapy

Device

UVB phototherapy

Other names: Waldmann phototherapy cabins

Primary outcomes

  1. 5-D Pruritus score and VAS Score at 16 weeks

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study 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

Acronym: PRUVAB

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Dec 6, 2010
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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