• Jeongin Kang, Goeun Lee, Jeonghun Kim, Youngeun Kim, Sunju Park, and Donghyo Lee.
• aDepartment of Ophthalmology, Otolaryngology, and Dermatology, College of Korean Medicine, Woo-Suk University, Jeonju bDepartment of Oriental Rehabilitation, National Rehabilitation Center, Seoul cEvidence-Based Healthcare Research Collaborating Center, Woo-Suk University, Jeonju dFuture Medicine Division, Korea Institute of Oriental Medicine eDepartment of Preventive Medicine, College of Korean Medicine, Daejeon University, Daejeon, Korea.
• Medicine (Baltimore). 2020 Jul 24; 99 (30): e20835.

IntroductionAllergic rhinitis (AR) is an immunoglobulin E (Ig E)-mediated inflammatory disease. Intranasal phototherapy is a promising treatment modality because it has a profound immunosuppressive effect, but the available evidence of its use for AR is insufficient. Therefore, rigorously designed randomized controlled trials (RCTs) are needed. Our objective is to describe the protocol for a feasibility trial to assess the effects and safety of intranasal phototherapy for the treatment of AR.Methods And AnalysisThis is a study protocol for a single-center, randomized, double-blind, parallel, placebo-controlled, investigator-initiated pilot study. A total of 40 patients with AR will be randomly assigned to the medical device or sham device group in a 1:1 ratio. The participants will receive intranasal phototherapy with a medical or sham device for 20 min 5 times a week for 2 weeks. The primary outcome will be the mean change in the Total Nasal Symptom Score (TNSS) from baseline to 2 weeks. The secondary outcomes will include the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score, Nasal Endoscopy Index, total serum Ig E level, and eosinophil count.DiscussionThe findings of this study will provide the basis for subsequent large-scale definitive RCTs to confirm the effects and safety of intranasal phototherapy for the treatment of nasal symptoms in patients with AR who do not respond well to conventional therapy. This study may assist in the development of noninvasive treatment for patients with AR.Trial RegistrationThis study was registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0003253).

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