Efficacy Study of Two Choices of Phototherapy on Itching Skin Diseases (PRUVAB)

This study is currently recruiting participants.
Verified June 2012 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01254240
First received: December 2, 2010
Last updated: June 22, 2012
Last verified: June 2012

December 2, 2010
June 22, 2012
December 2010
June 2012   (final data collection date for primary outcome measure)
5-D Pruritus score and VAS Score at 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01254240 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Efficacy Study of Two Choices of Phototherapy on Itching Skin Diseases
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Eczema
  • Psoriasis
  • Device: UVA / UVB phototherapy
    UVA / UVB phototherapy
    Other Name: Waldmann phototherapy cabins
  • Device: UVB phototherapy
    UVB phototherapy
    Other Name: Waldmann phototherapy cabins
  • Experimental: UVA/B phototherapy treatment
    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.
    Intervention: Device: UVA / UVB phototherapy
  • Active Comparator: UVB phototherapy treatment
    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.
    Intervention: Device: UVB phototherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
July 2012
June 2012   (final data collection date for primary outcome measure)

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:

  1. 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
  2. Heightened photosensitivity for UVA or UVB
  3. Withdrawal of consent to participate
  4. Concomitant participation in another study or having taken part in another clinical study within the last 30 days.
Both
18 Years and older
No
Contact: Alexander A. Navarini, MD PhD alexander.navarini@usz.ch
Contact: Guenther Hofbauer, MD, Leading Physician hofbauer@usz.ch
Switzerland
 
NCT01254240
DER-USZ-AAN-005
Yes
University of Zurich
University of Zurich
Not Provided
Principal Investigator: Guenther Hofbauer, MD, Leading Physician University Hospital Zurich, Division of Dermatology
University of Zurich
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP