{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T03:02:23Z","timestamp":1787022143621,"version":"build-2736575974"},"reference-count":30,"publisher":"Public Library of Science (PLoS)","issue":"3","license":[{"start":{"date-parts":[[2024,3,8]],"date-time":"2024-03-08T00:00:00Z","timestamp":1709856000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Liaison Committee for Education, Research, and Innovation in Central Norway","award":["2011\/16822 and 2019\/38881"],"award-info":[{"award-number":["2011\/16822 and 2019\/38881"]}]},{"DOI":"10.13039\/100008730","name":"Kreftforeningen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008730","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100011769","name":"St. Olavs Hospital Universitetssykehuset i Trondheim","doi-asserted-by":"publisher","award":["15\/9116-128"],"award-info":[{"award-number":["15\/9116-128"]}],"id":[{"id":"10.13039\/501100011769","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Topical photodynamic therapy (PDT) is an approved and widely used treatment for low-risk basal cell carcinoma (BCC), comprising two sessions with an interval of 1 week. Simplification of the treatment course can be cost-effective, easier to organize, and cause less discomfort for the patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec002\">\n                    <jats:title>Methods and findings<\/jats:title>\n                    <jats:p>We performed an investigator-initiated, single-blind, non-inferiority, randomized controlled multicentre study with the objective of investigating whether a simpler and more flexible PDT regimen was not &gt;10% less effective than the standard double PDT in the treatment of primary, superficial, and nodular \u22642 mm-thick BCC and evaluate the cosmetic outcome. With a non-inferiority margin of 0.1 and an expected probability complete response of 0.85, 190 tumours were required in each group. Histologically verified BCCs from seven centres in Norway were randomly assigned (1:1) to either receive a new regimen of single PDT with one possible re-treatment of non-complete responding tumours, or the standard regimen. The primary endpoint was the number of tumours with complete response or treatment failure at 36 months of follow-up, assessed by investigators blinded to the treatment regimen. Intention-to-treat and per-protocol analyses were performed. The cosmetic outcome was recorded. The study was registered with ClinicalTrials.gov, NCT-01482104, and EudraCT, 2011-004797-28.<\/jats:p>\n                    <jats:p>A total of 402 BCCs in 246 patients were included; 209 tumours assigned to the new and 193 to the standard regimen. After 36 months, there were 61 treatment failures with the new and 34 failures with the standard regimen. Complete response rate was 69.5% in the new and 81.1% in the standard treatment group. The difference was 11.6% (upper 97.5% CI 20.3), i.e. &gt; than the non-inferiority margin of 10%. Cosmetic outcomes were excellent or good in 92% and 89% following the new and standard regimens, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec003\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Single PDT with possible re-treatment of primary, superficial, and nodular \u2264 2-mm-thick BCC was significantly less effective than the approved standard double treatment. The cosmetic outcome was favorable and comparable between the two treatment groups.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1371\/journal.pone.0299718","type":"journal-article","created":{"date-parts":[[2024,3,8]],"date-time":"2024-03-08T13:29:58Z","timestamp":1709904598000},"page":"e0299718","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":9,"title":["New, simplified versus standard photodynamic therapy (PDT) regimen for superficial and nodular basal cell carcinoma (BCC): A single-blind, non-inferiority, randomised controlled multicentre study"],"prefix":"10.1371","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6848-9290","authenticated-orcid":true,"given":"Eidi","family":"Christensen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6493-297X","authenticated-orcid":true,"given":"Erik","family":"M\u00f8rk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olav Andreas","family":"Foss","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cato","family":"M\u00f8rk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susanne","family":"Kroon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars K\u00e5re","family":"Dotterud","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Per","family":"Helsing","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u00d8ystein","family":"Vatne","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eirik","family":"Skogvoll","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"Mj\u00f8nes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ingeborg Margrethe","family":"Bachmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2024,3,8]]},"reference":[{"issue":"5","key":"pone.0299718.ref001","doi-asserted-by":"crossref","first-page":"1069","DOI":"10.1111\/j.1365-2133.2012.10830.x","article-title":"A systematic review of worldwide incidence of nonmelanoma skin cancer","volume":"166","author":"A Lomas","year":"2012","journal-title":"Br J Dermatol"},{"issue":"5","key":"pone.0299718.ref002","doi-asserted-by":"crossref","first-page":"899","DOI":"10.1111\/bjd.20524","article-title":"British Association of Dermatologists guidelines for the management of adults with basal cell carcinoma 2021","volume":"185","author":"I Nasr","year":"2021","journal-title":"Br J Dermatol"},{"issue":"6","key":"pone.0299718.ref003","doi-asserted-by":"crossref","first-page":"1501","DOI":"10.1111\/bjd.13066","article-title":"Cost-effectiveness of topical imiquimod and fluorouracil vs. photodynamic therapy for treatment of superficial basal-cell carcinoma","volume":"171","author":"AH Arits","year":"2014","journal-title":"Br J Dermatol"},{"issue":"1","key":"pone.0299718.ref004","doi-asserted-by":"crossref","first-page":"10","DOI":"10.1177\/120347540500900104","article-title":"Metastatic basal cell carcinoma: report of two cases and literature review","volume":"9","author":"PT Ting","year":"2005","journal-title":"J Cutan Med Surg"},{"issue":"12","key":"pone.0299718.ref005","doi-asserted-by":"crossref","first-page":"2225","DOI":"10.1111\/jdv.16017","article-title":"European Dermatology Forum guidelines on topical photodynamic therapy 2019 Part 1: treatment delivery and established indications\u2014actinic keratoses, Bowen\u2019s disease and basal cell carcinomas.","volume":"33","author":"CA Morton","year":"2019","journal-title":"J Eur Acad Dermatol Venereol"},{"issue":"12","key":"pone.0299718.ref006","doi-asserted-by":"crossref","first-page":"2282","DOI":"10.1002\/(SICI)1097-0142(19970615)79:12<2282::AID-CNCR2>3.0.CO;2-O","article-title":"5-Aminolevulinic acid-based photodynamic therapy. 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