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

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ClinicalTrials.gov Identifier: NCT03085303
Recruitment Status : Completed
First Posted : March 21, 2017
Last Update Posted : August 7, 2018
Sponsor:
Collaborators:
University Hospital Goettingen
Philipps University Marburg Medical Center
University Hospital, Geneva
Information provided by (Responsible Party):
Philips Electronics Nederland BV

Tracking Information
First Submitted Date  ICMJE March 15, 2017
First Posted Date  ICMJE March 21, 2017
Last Update Posted Date August 7, 2018
Actual Study Start Date  ICMJE March 16, 2017
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2017)
Change in Eczema Area Severity Index (EASI) at end of treatment [ Time Frame: week 8 ]
Change in EASI from baseline to week 8
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2017)
  • Change in Score of Atopic Dermatitis (SCORAD) at end of treatment [ Time Frame: week 8 ]
    Change in SCORAD from baseline to 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
  • Change in Investigator Global assessment (IGA)at end of treatment [ Time Frame: week 8 ]
    Change in IGA from baseline to 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
  • EASI 50% [ Time Frame: week 8 ]
    Proportion of patients achieving 50% reduction from baseline EASI score at end of treatment
  • Change in Dermatology Life Quality Index (DLQI) at end of treatment [ Time Frame: week 8 ]
    Change in DLQI from baseline to week 8
  • Change in EASI at follow-up [ Time Frame: week 12 ]
    Change in EASI from end of treatment to week 12
  • Time until treatment response [ Time Frame: week 0-8 ]
    Time until Treatment Response is seen
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Atopic Dermatitis by a Full-Body Blue Light Device
Official Title  ICMJE Treatment of Atopic Dermatitis by a Full-Body Blue Light Device
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Patients are blinded by wearing tinted glasses for eye protection which disenable distinction of different wave lengths of light. Medical doctors will examine patients in other rooms than those equipped with the investigational medical devices. These examiners are blinded and are therefore not involved in the preparation and process of the irradiation.
Primary Purpose: Treatment
Condition  ICMJE Dermatitis, Atopic
Intervention  ICMJE Device: Full Body Blue Light Device
Full body blue light irradiation (phototherapy) of atopic dermatitis patients.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Full Body Blue Light Device
  • 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.
    Intervention: Device: Full Body Blue Light Device
  • 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.
    Intervention: Device: Full Body Blue Light Device
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2018)
87
Original Estimated Enrollment  ICMJE
 (submitted: March 20, 2017)
150
Actual Study Completion Date  ICMJE July 31, 2018
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03085303
Other Study ID Numbers  ICMJE FBB-CT01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Philips Electronics Nederland BV
Study Sponsor  ICMJE Philips Electronics Nederland BV
Collaborators  ICMJE
  • University Hospital Goettingen
  • Philipps University Marburg Medical Center
  • University Hospital, Geneva
Investigators  ICMJE
Principal Investigator: Michael Schoen, Prof University Medical Center Göttingen, Clinic of Dermatology, Venereology and Allergology
PRS Account Philips Electronics Nederland BV
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP