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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Eczema
Psoriasis
 Device: UVA / UVB phototherapy
Device: UVB phototherapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 5-D Pruritus score and VAS Score at 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: December 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Device: UVA / UVB phototherapy
UVA / UVB phototherapy
Other Name: Waldmann phototherapy cabins
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.
 Device: UVB phototherapy
UVB phototherapy
Other Name: Waldmann phototherapy cabins

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254240

Contacts
Contact: Alexander A. Navarini, MD PhD alexander.navarini@usz.ch
Contact: Guenther Hofbauer, MD, Leading Physician hofbauer@usz.ch

Locations
Switzerland
University Hospital Zurich, Department of Dermatology Recruiting
Zurich, Switzerland, 8091
Sub-Investigator: Alexander A Navarini, MD PhD            
Principal Investigator: Guenther Hofbauer, MD            
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Guenther Hofbauer, MD, Leading Physician University Hospital Zurich, Division of Dermatology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01254240     History of Changes
Other Study ID Numbers: DER-USZ-AAN-005
Study First Received: December 2, 2010
Last Updated: June 22, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Eczema
Psoriasis
Dermatitis
 Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on June 17, 2013