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Trial record 13 of 154 for:    Dermatitis, Atopic, 8

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Device: Full Body Blue Light Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
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
Official Title: Treatment of Atopic Dermatitis by a Full‐Body Blue Light Device
Actual Study Start Date : March 16, 2017
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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.




Primary Outcome Measures :
  1. Change in Eczema Area Severity Index (EASI) at end of treatment [ Time Frame: week 8 ]
    Change in EASI from baseline to week 8


Secondary Outcome Measures :
  1. Change in Score of Atopic Dermatitis (SCORAD) at end of treatment [ Time Frame: week 8 ]
    Change in SCORAD from baseline to week 8

  2. 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

  3. Change in Investigator Global assessment (IGA)at end of treatment [ Time Frame: week 8 ]
    Change in IGA from baseline to week 8

  4. Change in itch Visual Analogue Scale (VAS) at end of treatment [ Time Frame: week 8 ]
    Change in itch VAS from baseline to week 8

  5. EASI 50% [ Time Frame: week 8 ]
    Proportion of patients achieving 50% reduction from baseline EASI score at end of treatment

  6. Change in Dermatology Life Quality Index (DLQI) at end of treatment [ Time Frame: week 8 ]
    Change in DLQI from baseline to week 8

  7. Change in EASI at follow‐up [ Time Frame: week 12 ]
    Change in EASI from end of treatment to week 12

  8. Time until treatment response [ Time Frame: week 0-8 ]
    Time until Treatment Response is seen



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085303


Locations
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Germany
University Hospital Goettingen
Goettingen, Germany, 37075
University Hospital Marburg
Marburg, Germany, 35043
Switzerland
University Hospital Geneva
Geneva, Switzerland, 1205
Sponsors and Collaborators
Philips Electronics Nederland BV
University Hospital Goettingen
Philipps University Marburg Medical Center
University Hospital, Geneva
Investigators
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Principal Investigator: Michael Schoen, Prof University Medical Center Göttingen, Clinic of Dermatology, Venereology and Allergology

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Philips Electronics Nederland BV
ClinicalTrials.gov Identifier: NCT03085303     History of Changes
Other Study ID Numbers: FBB-CT01
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases