Efficacy Study of Two Choices of Phototherapy on Itching Skin Diseases

NCT ID: NCT01254240

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2015-12-31

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.

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.

Conditions

Eczema; Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

UVA / UVB phototherapy

Intervention Type: DEVICE

UVA / UVB phototherapy

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.

Group Type: ACTIVE_COMPARATOR

UVB phototherapy

Intervention Type: DEVICE

UVB phototherapy

Interventions

UVA / UVB phototherapy

UVA / UVB phototherapy

Intervention Type: DEVICE

UVB phototherapy

UVB phototherapy

Intervention Type: DEVICE

Other Intervention Names

Waldmann phototherapy cabins; Waldmann phototherapy cabins

Eligibility Criteria

Inclusion Criteria

• 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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guenther Hofbauer, MD, Leading Physician

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Dermatology

Locations

University Hospital Zurich, Department of Dermatology

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

DER-USZ-AAN-005

Identifier Type: -

Identifier Source: org_study_id