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Dermatitis, AtopicAD-BlueNCT03085303

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

A study testing Full Body Blue Light Device in people with Dermatitis, Atopic, run by Philips Electronics Nederland BV at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Dermatitis, Atopic
What is being tested?
Full Body Blue Light Device
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
87 participants
Where
3 sitesin 2 countries
Study dates
16 Mar 2017to 31 Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 28Show fewer
  • 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

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Germany2 sites

  • University Hospital Goettingen

    Göttingen, 37075

  • University Hospital Marburg

    Marburg, 35043

Other trials in Germany

Switzerland1 site

  • University Hospital Geneva

    Geneva, 1205

Other trials in Switzerland

About this study

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.

Being tested
Full Body Blue Light Device
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Full Body Blue Light DeviceDevice

    Full body blue light irradiation (phototherapy) of atopic dermatitis patients.

Study groups in NCT03085303
Study groupRoleWhat they receive
Blue light at 415nmExperimentalFull body irradiation for 30min (15 min. each body side) with blue light at 415nm peak wavelength with full body blue device.
Receives: Device: Full Body Blue Light Device
Blue light at 450nmExperimentalFull body irradiation for 30min (15 min. each body side) with blue light at 450nm peak wavelength with full body blue device.
Receives: Device: Full Body Blue Light Device
PlaceboPlacebo comparatorFull 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.
Receives: Device: Full Body Blue Light Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Eczema Area Severity Index (EASI) at end of treatment

    Change in EASI from baseline to week 8

    Measured: week 8

Secondary outcomes (8)

  1. Change in Score of Atopic Dermatitis (SCORAD) at end of treatment

    Change in SCORAD from baseline to week 8

    Measured: week 8

  2. Change in Patient Oriented Score of Atopic Dermatitis (PO-SCORAD) at end of treatment

    Change in PO-SCORAD from baseline to week 8

    Measured: week 8

  3. Change in Investigator Global assessment (IGA)at end of treatment

    Change in IGA from baseline to week 8

    Measured: week 8

  4. Change in itch Visual Analogue Scale (VAS) at end of treatment

    Change in itch VAS from baseline to week 8

    Measured: week 8

  5. EASI 50%

    Proportion of patients achieving 50% reduction from baseline EASI score at end of treatment

    Measured: week 8

  6. Change in Dermatology Life Quality Index (DLQI) at end of treatment

    Change in DLQI from baseline to week 8

    Measured: week 8

  7. Change in EASI at follow-up

    Change in EASI from end of treatment to week 12

    Measured: week 12

  8. Time until treatment response

    Time until Treatment Response is seen

    Measured: week 0-8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2017
  2. Study start16 Mar 2017
  3. Primary completion31 Jul 2018
  4. Study completion31 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03085303
Sponsor's protocol ID
FBB-CT01
Acronym
AD-Blue
Status last verified
Aug 2018
First submitted
15 Mar 2017
Last updated
7 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Keemss K, Pfaff SC, Born M, Liebmann J, Merk HF, von Felbert V. Prospective, Randomized Study on the Efficacy and Safety of Local UV-Free Blue Light Treatment of Eczema. Dermatology. 2016;232(4):496-502. doi: 10.1159/000448000. Epub 2016 Aug 19.

    PubMed 27537360

  • Buhl T, Santibanez Santana M, Forkel S, Kromer C, Seidel J, Mobs C, Pfutzner W, Pfeiffer S, Laubach HJ, Boehncke WH, Liebmann J, Born M, Schon MP. Full-body blue light irradiation as treatment for atopic dermatitis: a randomized sham-controlled clinical trial (AD-Blue). J Dtsch Dermatol Ges. 2023 Dec;21(12):1500-1510. doi: 10.1111/ddg.15211. Epub 2023 Oct 9.

    PubMed 37814388

  • Kromer C, Nuhnen VP, Pfutzner W, Pfeiffer S, Laubach HJ, Boehncke WH, Liebmann J, Born M, Schon MP, Buhl T. Treatment of Atopic Dermatitis Using a Full-Body Blue Light Device (AD-Blue): Protocol of a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jan 8;8(1):e11911. doi: 10.2196/11911.

    PubMed 30622089

Questions about this trial

What is this clinical trial studying?

A study testing Full Body Blue Light Device in people with Dermatitis, Atopic, run by Philips Electronics Nederland BV at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Eczema Area Severity Index (EASI) at end of treatment (time frame: week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03085303, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.

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