Eczema | Efficacy Study of Two Choices of Phototherapy on Itching Skin Diseases
Eczema research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:UVA / UVB phototherapyUVA / UVB phototherapy
Device:UVB phototherapyUVB phototherapy
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
UVA/B phototherapy treatmentUVA/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 treatmentUVB 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.
Start Date: December 2010
Completed Date: December 2015
Phase: Phase 2
Primary Outcome: 5-D Pruritus score and VAS Score at 16 weeks
Study sponsors, principal investigator, and references
Principal Investigator: Guenther Hofbauer, MD, Leading Physician
Lead Sponsor: University of Zurich