Treatment of Atopic Dermatitis Using a Full-Body Blue Light Device (AD-Blue): Protocol of a Randomized Controlled Trial
- PMID: 30622089
- PMCID: PMC6329412
- DOI: 10.2196/11911
Treatment of Atopic Dermatitis Using a Full-Body Blue Light Device (AD-Blue): Protocol of a Randomized Controlled Trial
Abstract
Background: Irradiation with visible blue light (wavelength 400-495 nm) is a promising, effective, and safe new treatment option for chronic inflammatory skin diseases such as psoriasis and atopic dermatitis.
Objective: We will perform a multicenter, placebo-controlled, double-blinded, 3-armed, prospective, randomized controlled trial to investigate the efficacy and safety of full-body blue light devices (wavelengths: 415 nm and 450 nm) compared with that of placebo irradiation for the treatment of atopic dermatitis.
Methods: We are planning to enroll a total of 150 patients at the University hospitals in Göttingen (Germany), Marburg (Germany), and Geneva (Switzerland).
Results: The trial was approved by the lead ethics committee of the medical faculty of the University of Göttingen (21/11/16). Further approvals were obtained from local and federal authorities (ethics committee Marburg, Cantonal Commission for Research Ethics Geneva, Suisse Medic, and Bundesinstitut für Arzneimittel und Medizinprodukte).
Conclusions: We will disseminate the results in a peer-reviewed journal.
Trial registration: ClinicalTrials.gov NCT03085303; https://clinicaltrials.gov/ct2/show/NCT03085303 (Archived by WebCite at http://www.webcitation.org/73ucqkkA1).
International registered report identifier (irrid): DERR1-10.2196/11911.
Keywords: atopic dermatitis; atopic eczema; blue light; irradiation; ultraviolet light.
©Christian Kromer, Viktoria P Nühnen, Wolfgang Pfützner, Sebastian Pfeiffer, Hans-Joachim Laubach, Wolf-Henning Boehncke, Joerg Liebmann, Matthias Born, Michael P Schön, Timo Buhl. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 08.01.2019.
Conflict of interest statement
Conflicts of Interest: MB and JL are employees of Philips Light & Health.
Figures
References
-
- Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol. 2001 Feb;10(1):11–8. - PubMed
-
- Stalder J, Barbarot S, Wollenberg A, Holm EA, De Raeve L, Seidenari S, Oranje A, Deleuran M, Cambazard F, Svensson A, Simon D, Benfeldt E, Reunala T, Mazereeuv J, Boralevi F, Kunz B, Misery L, Mortz CG, Darsow U, Gelmetti C, Diepgen T, Ring J, Moehrenschlager M, Gieler U, Taïeb A, PO-SCORAD Investigators Group Patient-Oriented SCORAD (PO-SCORAD): a new self-assessment scale in atopic dermatitis validated in Europe. Allergy. 2011 Aug;66(8):1114–21. doi: 10.1111/j.1398-9995.2011.02577.x. - DOI - PubMed
Associated data
LinkOut - more resources
Full Text Sources
Medical
