{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,11]],"date-time":"2026-05-11T12:32:05Z","timestamp":1778502725292,"version":"3.51.4"},"reference-count":14,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2018,4,17]],"date-time":"2018-04-17T00:00:00Z","timestamp":1523923200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Japan Tobacco Inc."}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Dermatology"],"published-print":{"date-parts":[[2018,6]]},"abstract":"Abstract<\/jats:title>The purpose of the present two phase 1 studies was to assess the safety, tolerability and pharmacokinetics for topical application of a novel Janus kinase (JAK<\/jats:styled-content>) inhibitor, JTE<\/jats:styled-content>\u2010052, in Japanese healthy adult male volunteers and Japanese adult patients with atopic dermatitis (AD<\/jats:styled-content>). Additionally, exploratory investigation was performed on the efficacy for disease severity and pruritus score in AD<\/jats:styled-content> patients. In the QBX<\/jats:styled-content>1\u20101 study, the cutaneous safety of JTE<\/jats:styled-content>\u2010052 ointment by a patch test and a photo patch test was assessed in an intra\u2010individual comparative study using placebo ointment, white petrolatum and non\u2010application as comparators. The study demonstrated that JTE<\/jats:styled-content>\u2010052 ointment would be associated with a low potential for phototoxicity but had no potential for skin irritation or photoallergy. In the QBX<\/jats:styled-content>1\u20102 study, it was revealed that the systemic exposure to JTE<\/jats:styled-content>\u2010052 in both healthy volunteers with normal skin and AD<\/jats:styled-content> patients with inflamed skin was low in application of not only 1% but also 3% JTE<\/jats:styled-content>\u2010052 ointment. JTE<\/jats:styled-content>\u2010052 ointments of 1% and 3% were generally safe and well tolerated in both populations. In a repeated twice\u2010daily application for 7 days, the efficacy of JTE<\/jats:styled-content>\u2010052 ointment to AD<\/jats:styled-content> patients was observed with both 1% and 3% ointments in the exploratory investigations evaluated by Eczema Area and Severity Index, Investigator's Global Assessment and Numeric Rating Scale assessments. The mean scores for each assessment declined from the baseline throughout the study. These results suggest that the treatment of JTE<\/jats:styled-content>\u2010052 ointment is generally safe and effective in AD<\/jats:styled-content> patients, although further large confirmatory studies are needed.<\/jats:p>","DOI":"10.1111\/1346-8138.14322","type":"journal-article","created":{"date-parts":[[2018,4,17]],"date-time":"2018-04-17T18:11:26Z","timestamp":1523988686000},"page":"701-709","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":45,"title":["Phase 1 studies to assess the safety, tolerability and pharmacokinetics of JTE\u2010052 (a novel Janus kinase inhibitor) ointment in Japanese healthy volunteers and patients with atopic dermatitis"],"prefix":"10.1111","volume":"45","author":[{"given":"Hidemi","family":"Nakagawa","sequence":"first","affiliation":[{"name":"Department of Dermatology The Jikei University School of Medicine Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Osamu","family":"Nemoto","sequence":"additional","affiliation":[{"name":"Kojinkai Sapporo Skin Clinic Hokkaido Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7405-5301","authenticated-orcid":false,"given":"Hiroyuki","family":"Yamada","sequence":"additional","affiliation":[{"name":"Clinical Development Department Pharmaceutical Division Japan Tobacco Inc. Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takeshi","family":"Nagata","sequence":"additional","affiliation":[{"name":"Clinical Development Department Pharmaceutical Division Japan Tobacco Inc. Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Noriko","family":"Ninomiya","sequence":"additional","affiliation":[{"name":"Clinical Development Department Pharmaceutical Division Japan Tobacco Inc. Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,4,17]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra074081"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.13392"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1470.2005.22303.x"},{"key":"e_1_2_7_5_1","first-page":"1217","article-title":"Clinical guidance for treatment of patients with atopic dermatitis by tacrolimus ointment 0.1% and 0.03%","volume":"57","author":"Japanese FK 506 Ointment Study Group","year":"2003","journal-title":"Jpn J Clin Dermatol"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.immuni.2012.03.014"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00011-014-0782-9"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/exd.13370"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jdermsci.2013.02.001"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2015.03.051"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jid.2016.02.556"},{"key":"e_1_2_7_12_1","unstructured":"KohnoY YamamotoS.The study group for research on allergic disease and immunology by Ministry of Health Labour and Welfare of Japan. Guidelines for the treatment of atopic dermatitis.2008(In Japanese)."},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1034\/j.1600-0625.2001.100102.x"},{"key":"e_1_2_7_14_1","first-page":"301","article-title":"Basic studies on the standerdization of patch test","volume":"80","author":"Kawamura T","year":"1970","journal-title":"Jap J Dermatol"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cell.2017.08.006"}],"container-title":["The Journal of Dermatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2F1346-8138.14322","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1346-8138.14322","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,23]],"date-time":"2023-09-23T18:41:21Z","timestamp":1695494481000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/1346-8138.14322"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,4,17]]},"references-count":14,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2018,6]]}},"alternative-id":["10.1111\/1346-8138.14322"],"URL":"https:\/\/doi.org\/10.1111\/1346-8138.14322","archive":["Portico"],"relation":{},"ISSN":["0385-2407","1346-8138"],"issn-type":[{"value":"0385-2407","type":"print"},{"value":"1346-8138","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,4,17]]},"assertion":[{"value":"2017-11-28","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-03-06","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-04-17","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}