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About 70% of the patients exhibit extremely severe sunburn reactions and most of them develop neurological symptoms, including sensorineural hearing impairment and progressive peripheral and central nervous disorders beginning from childhood ages. In the preclinical study, we found that N-acetyl-5-methoxytryptamine was effective in suppressing skin tumour development in addition to improvement of auditory brainstem response in chronically ultraviolet-irradiated XP-A model mice.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>On the bases of the preclinical study, we conduct a clinical trial on the efficacy of NPC-15 for patients with XP with exaggerated sunburn reaction type by a multicentre, double-blinded placebo-controlled, two-group crossover study followed by a 52\u2009weeks open study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethics approval is overseen by the Kobe University Institutional Review Board and Osaka Medical and Pharmaceutical University Institutional Review Board, and the study is conducted in accordance with the approved protocol. All participants will be required to provide written informed consent. Findings will be disseminated through scientific and professional conferences and peer-reviewed journal publications. The data sets generated during the study will be available from the corresponding author on reasonable request.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>jRCTs051210181.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-068112","type":"journal-article","created":{"date-parts":[[2023,3,22]],"date-time":"2023-03-22T10:38:50Z","timestamp":1679481530000},"page":"e068112","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":5,"title":["Clinical trial on the efficacy and safety of NPC-15 for patients with xeroderma pigmentosum exaggerated sunburn reaction type: XP-1 study protocol for a multicentre, double-blinded, placebo-controlled, two-group crossover study followed by a long-term open study in Japan"],"prefix":"10.1136","volume":"13","author":[{"given":"Mariko","family":"Tsujimoto","sequence":"first","affiliation":[{"name":"Dermatology, Kobe University Graduate School of Medicine School of Medicine, Kobe, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5997-514X","authenticated-orcid":false,"given":"Yasumasa","family":"Kakei","sequence":"additional","affiliation":[{"name":"Clinical & Translational Research Center, Kobe University Hospital, Kobe, Japan"},{"name":"Oral and Maxillofacial Surgery, Kobe University Graduate School of Medicine School of Medicine, Kobe, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nozomi","family":"Yamano","sequence":"additional","affiliation":[{"name":"Dermatology, Kobe University Graduate School of Medicine School of Medicine, Kobe, 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