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.