• Jeongin Kang, Goeun Lee, Miju Son, Youngeun Kim, Namhun Heo, and Donghyo Lee.
• Department of Ophthalmology, Otolaryngology, and Dermatology, College of Korean Medicine, Woo-Suk University, Jeonju.
• Medicine (Baltimore). 2020 Jul 24; 99 (30): e21183e21183.

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 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 an RCT 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, parallel (acupuncture-controlled), open-label, investigator-initiated, pilot study. A total of 80 patients with AR will be randomly assigned to the intranasal phototherapy or acupuncture group at a 1:1 ratio. The participants will receive intranasal phototherapy with medical or acupuncture treatment for 20 minutes, 3 times a week for 4 weeks. The primary outcome will be the mean change in the total nasal symptom score (TNSS) from baseline to 4 weeks. The secondary outcomes will include the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score, Nasal Endoscopy Index, total serum immunoglobulin E (Ig E) level and eosinophil count.DiscussionThe findings of this study will provide the basis for the design and implementation of RCTs investigating the effects and safety of intranasal phototherapy for AR. Additionally, it will provide preliminary evidence of intranasal phototherapy for use in AR.Trial RegistrationThis study was registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0004079).

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