title: Topical application of Jaungo in atopic dermatitis patients: study protocol for a randomized, controlled trial.
abstract: Atopic dermatitis (AD) is a common pruritic inflammatory skin disease with increasing prevalence. It can manifest with many different clinical phenotypes; however, in its chronic stage, hyperpigmentation, excoriation, lichenification, and dryness are the main symptoms. Jaungo comprises two herbs, Lithospermi radix and Angelica gigantis radix, and three carrier oils, and is an approved herbal ointment for xerosis cutis in Korea. In past studies, we demonstrated that Jaungo had anti-inflammatory and antiallergic activity in in vitro and in vivo AD models; however, there are few relevant randomized controlled clinical trials on Jaungo in AD.
  
  
  
  A randomized, double-blind, placebo-controlled, single-center, phase IIa clinical trial was designed to investigate the safety, preliminary efficacy, and dose response of Jaungo in AD. The study protocol was approved by the Institutional Review Boards of the Kyung Hee University Korean Medicine Hospital (No. KOMCIRB-160617-HR-027) and the Korea Food and Drug Administration (No. 30907). The study aims to enroll 34 AD patients to be randomly distributed among three parallel groups: treatment 1, treatment 2, and the placebo group. Treatment group 1 applies Jaungo twice a day, while treatment group 2 applies Jaungo and the placebo ointment once a day, separately, and the placebo group applies the placebo ointment twice a day, for a total of 3 weeks each. Participants will be evaluated for eczema before and after the application of the ointments based on several parameters including the Eczema Area and Severity Index, the SCORing of Atopic Dermatitis Index, the Dermatology Life Quality Index, transepidermal water loss, total IgE level, eosinophil count, and IL-17, IL-22, and IFN-γ levels.
  
  
  
  The trial is currently ongoing and the enrollment of subjects has been initiated. There is an urgent need to develop a drug for the treatment of dry, hyperpigmented, scaly, and thickened skin in chronic-stage AD. This study will determine the efficacy and safety of Jaungo in AD, providing evidence for specific AD symptoms treated by Jaungo.
  
  
  
  Clinical Trials.gov, identifier: NCT02900131 . Registered on 2 September 2016. Korea Clinical Research Information Service, identifier: KCT0002060 . Registered on 22 July 2016.
authors.affiliation: Department of Korean Dermatology, Kyung Hee University Hospital at Gangdong, College of Korean Medicine, Kyung Hee University, Seoul, South Korea.
authors.forename: Younghee
authors.initials: Y
authors.lastname: Yun
authors.affiliation: Department of Preventive Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
authors.forename: Youme
authors.initials: Y
authors.lastname: Ko
authors.affiliation: Department of Korean Dermatology, Kyung Hee University Hospital at Gangdong, College of Korean Medicine, Kyung Hee University, Seoul, South Korea.
authors.forename: Jin-Hyang
authors.initials: JH
authors.lastname: Ahn
authors.affiliation: Department of Preventive Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
authors.forename: Bo-Hyoung
authors.initials: BH
authors.lastname: Jang
authors.affiliation: Department of Ophthalmology, Otolaryngology and Dermatology of Korean Medicine, College of Korean Medicine, Kyung Hee University, Seoul, South Korea.
authors.forename: Kyuseok
authors.initials: K
authors.lastname: Kim
authors.affiliation: Department of Preventive Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
authors.forename: Seong-Gyu
authors.initials: SG
authors.lastname: Ko
authors.affiliation: Department of Korean Dermatology, Kyung Hee University Hospital at Gangdong, College of Korean Medicine, Kyung Hee University, Seoul, South Korea. inhwajun@khnmc.or.kr.
authors.forename: Inhwa
authors.initials: I
authors.lastname: Choi
mesh_terms: D000279:Administration, Cutaneous; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002985:Clinical Protocols; D003876:Dermatitis, Atopic / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D011788:Quality of Life; D012074:Remission Induction; D056910:Republic of Korea; D012107:Research Design; D012867:Skin / Q000187:drug effects* / Q000276:immunology / Q000473:pathology; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D003879:Dermatologic Agents; D004365:Drugs, Chinese Herbal; C000626557:jaungo
keywords: Administration; Application; Atopic; Dermatitis; Jaungo; Phytotherapy; Randomized controlled trial; Topical