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| Name | Class |
|---|---|
| University Hospital Goettingen | OTHER |
| Philipps University Marburg | OTHER |
| University Hospital, Geneva | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full Body Blue Light Device | Device | Full body blue light irradiation (phototherapy) of atopic dermatitis patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Eczema Area Severity Index (EASI) at end of treatment | Change in EASI from baseline to week 8 | week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Score of Atopic Dermatitis (SCORAD) at end of treatment | Change in SCORAD from baseline to week 8 | week 8 |
| Change in Patient Oriented Score of Atopic Dermatitis (PO-SCORAD) at end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
General
Medical History
Concomitant medication/treatment in medical history and during the study
Within 8 weeks prior to baseline visit:
Within 4 weeks prior to baseline visit:
Within 2 weeks prior to baseline visit:
Within 3 days prior to baseline visit:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Schoen, Prof | University Medical Center Göttingen, Clinic of Dermatology, Venereology and Allergology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Goettingen | Göttingen | 37075 | Germany | |||
| University Hospital Marburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27537360 | Background | 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. | |
| 37814388 | Derived | 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. |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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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.
Change in PO-SCORAD from baseline to week 8
| week 8 |
| Change in Investigator Global assessment (IGA)at end of treatment | Change in IGA from baseline to week 8 | week 8 |
| Change in itch Visual Analogue Scale (VAS) at end of treatment | Change in itch VAS from baseline to week 8 | week 8 |
| EASI 50% | 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 | Change in DLQI from baseline to week 8 | week 8 |
| Change in EASI at follow-up | Change in EASI from end of treatment to week 12 | week 12 |
| Time until treatment response | Time until Treatment Response is seen | week 0-8 |
| Marburg |
| 35043 |
| Germany |
| University Hospital Geneva | Geneva | 1205 | Switzerland |
| 30622089 | Derived | 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. |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |