Treatment of Atopic Dermatitis by a Full-Body Blue Light Device (AD-Blue)

August 6, 2018 updated by: Philips Electronics Nederland BV
Multicentric, placebo-controlled, double-blinded, three-armed, prospective, randomized controlled trial.150 patients diagnosed with atopic dermatitis will be randomized to arm 1 (irradiation for 30min at 415nm wavelength), arm 2 (irradiation for 30min at 450nm wavelength), and arm 3 (irradiation for 30min at low-dose (placebo)). Irradiation will be scheduled 3 times a week for 8 weeks. Patients will be followed up for four weeks after the last irradiation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Goettingen, Germany, 37075
        • University Hospital Goettingen
      • Marburg, Germany, 35043
        • University Hospital Marburg
  • Switzerland
      • Geneva, Switzerland, 1205
        • University Hospital Geneva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed and dated informed consent prior to any study mandated procedure
  • Good health as determined by the Investigator
  • Willing and able to comply with study requirements
  • Atopic dermatitis (AD) fulfilling the United Kingdom (UK) criteria of AD
  • Age between 18 and ≤ 75 years
  • Reliable method of contraception for women of childbearing potential (i.e. low failure rate less than 1% per year; e.g. oral contraceptives, intrauterine device [IUD] or transdermal contraceptive patch)
  • Willing to abstain from excessive sun / UV exposure (e.g. sunbathe, solarium) during the course of the study
  • Body Mass Index ≥ 18 and ≤ 35

Exclusion Criteria:

General

  • Inmates of psychiatric wards, prisons, or other state institutions
  • Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
  • Participation in another clinical trial within the last 30 days
  • Pregnant or nursing women
  • Risk of non-compliance with study procedures

Medical History

  • Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases may include cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease, and others.
  • Clinically relevant abnormalities in hematology, or blood chemistry at screening.
  • Positive HIV-1/2Ab, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibodies (HCV-Ab) test at screening.
  • Diastolic blood pressure above 95 mmHg.
  • Febrile illness within 2 weeks prior to baseline visit.
  • Alcohol or drug abuse within 12 months prior to screening (i.e., Regular daily consumption of more than 1 liter of beer or the equivalent quantity of approximately 40 g of alcohol in another form.)
  • Photodermatosis and/or significant photosensitivity, including porphyria and/or hypersensitivity to porphyrins as well as photosensitivity due to present or past (within the last year) intake of amiodarone.
  • Congenital or acquired immunodeficiency
  • Patients who have been diagnosed with invasive skin cancer at any time (=malignant cells invaded below the basal membrane of the epidermis), or with severe actinic damage present at baseline visit.
  • Patients with genetic deficiencies attached with increased sensitivity to light or increased risk to dermatologic cancer (i.e. Xeroderma pigmentosum, Cockayne Syndrome, Bloom-Syndrome).

Concomitant medication/treatment in medical history and during the study

Within 8 weeks prior to baseline visit:

  • Systemic immunosuppression treatment (steroids, cyclosporine, azathioprine, Mycophenolate Mofetil (MMF))

Within 4 weeks prior to baseline visit:

  • UV radiation treatment

Within 2 weeks prior to baseline visit:

  • Topical steroid treatment
  • Topical calcineurin inhibitor treatment

Within 3 days prior to baseline visit:

  • Photo-sensitising medication (e.g. psoralen, tetracyclines, hydrochlorothiazide, phenothiazines, quinolones, hypericumperforatum, arnica, valerian, tar) as assessed by the regular medication plan of the patient
  • colours (e.g. thiazide, toluidine blue, eosin, methylene blue, rose Bengal, acridine) which will be visible on the patient's skin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Blue light at 415nm
Full body irradiation for 30min (15 min. each body side) with blue light at 415nm peak wavelength with full body blue device.
Device: Full Body Blue Light Device
Full body blue light irradiation (phototherapy) of atopic dermatitis patients.
EXPERIMENTAL: Blue light at 450nm
Full body irradiation for 30min (15 min. each body side) with blue light at 450nm peak wavelength with full body blue device.
Device: Full Body Blue Light Device
Full body blue light irradiation (phototherapy) of atopic dermatitis patients.
PLACEBO_COMPARATOR: Placebo
Full body irradiation for 30min (15 min. each body side) with blue light at 450nm peak wavelength with a low dose setting (not therapeutically active) of the full body blue device.
Device: Full Body Blue Light Device
Full body blue light irradiation (phototherapy) of atopic dermatitis patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Eczema Area Severity Index (EASI) at end of treatment
Time Frame: week 8
Change in EASI from baseline to week 8
week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Score of Atopic Dermatitis (SCORAD) at end of treatment
Time Frame: week 8
Change in SCORAD from baseline to week 8
week 8
Change in Patient Oriented Score of Atopic Dermatitis (PO-SCORAD) at end of treatment
Time Frame: week 8
Change in PO-SCORAD from baseline to week 8
week 8
Change in Investigator Global assessment (IGA)at end of treatment
Time Frame: week 8
Change in IGA from baseline to week 8
week 8
Change in itch Visual Analogue Scale (VAS) at end of treatment
Time Frame: week 8
Change in itch VAS from baseline to week 8
week 8
EASI 50%
Time Frame: week 8
Proportion of patients achieving 50% reduction from baseline EASI score at end of treatment
week 8
Change in Dermatology Life Quality Index (DLQI) at end of treatment
Time Frame: week 8
Change in DLQI from baseline to week 8
week 8
Change in EASI at follow-up
Time Frame: week 12
Change in EASI from end of treatment to week 12
week 12
Time until treatment response
Time Frame: week 0-8
Time until Treatment Response is seen
week 0-8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Electronics Nederland BV

Collaborators

University Hospital, Geneva
Philipps University Marburg Medical Center
University Hospital Goettingen

Investigators

  • Principal Investigator: Michael Schoen, Prof, University Medical Center Göttingen, Clinic of Dermatology, Venereology and Allergology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 16, 2017

Primary Completion (ACTUAL)

July 31, 2018

Study Completion (ACTUAL)

July 31, 2018

Study Registration Dates

First Submitted

March 15, 2017

First Submitted That Met QC Criteria

March 20, 2017

First Posted (ACTUAL)

March 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FBB-CT01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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