Efficacy Study of Two Choices of Phototherapy on Itching Skin Diseases
PRUVAB
Randomized Double-blind Phase 2 Study of Impact of Ultraviolet A (UVA) on Pruritus During Ultraviolet A/B (UVA/B) Phototherapy of Inflammatory Dermatoses
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2010
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 2, 2010
CompletedFirst Posted
Study publicly available on registry
December 6, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMay 12, 2016
May 1, 2016
5 years
December 2, 2010
May 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
5-D Pruritus score and VAS Score at 16 weeks
16 weeks
Study Arms (2)
UVA/B phototherapy treatment
EXPERIMENTALUVA/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.
UVB phototherapy treatment
ACTIVE COMPARATORUVB 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.
Interventions
UVA / UVB phototherapy
UVB phototherapy
Eligibility Criteria
You may qualify if:
- \- Pruritic inflammatory diseases such as atopic dermatitis, other types of eczema, psoriasis, prurigo simplex subacuta and others.
- Pruritus VAS Score 5 or higher at screening.
- Dermatological indication for a phototherapy with UVB nb / UVA
- Oral and written informed patient consent
You may not qualify if:
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Zurich, Department of Dermatology
Zurich, 8091, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guenther Hofbauer, MD, Leading Physician
University Hospital Zurich, Division of Dermatology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2010
First Posted
December 6, 2010
Study Start
December 1, 2010
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
May 12, 2016
Record last verified: 2016-05