NCT03085303

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

March 16, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

1.4 years

First QC Date

March 15, 2017

Last Update Submit

August 6, 2018

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

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

    Change in EASI from baseline to week 8

    week 8

Secondary Outcomes (8)

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

    week 8

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

    week 8

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

    week 8

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

    week 8

  • EASI 50%

    week 8

  • +3 more secondary outcomes

Study Arms (3)

Blue light at 415nm

EXPERIMENTAL

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

Blue light at 450nm

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Full Body Blue Light DeviceDEVICE

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

Blue light at 415nmBlue light at 450nmPlacebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital Goettingen

Göttingen, 37075, Germany

Location

University Hospital Marburg

Marburg, 35043, Germany

Location

University Hospital Geneva

Geneva, 1205, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 27537360BACKGROUND

  • 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.

    PMID: 37814388DERIVED

  • 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.

    PMID: 30622089DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Michael Schoen, Prof

    University Medical Center Göttingen, Clinic of Dermatology, Venereology and Allergology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2017

First Posted

March 21, 2017

Study Start

March 16, 2017

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

August 7, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)DE(2)