{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,9]],"date-time":"2026-01-09T23:31:10Z","timestamp":1768001470411,"version":"3.49.0"},"reference-count":22,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2024,2,27]],"date-time":"2024-02-27T00:00:00Z","timestamp":1708992000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pediatric Dermatology"],"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>Controlling molluscum contagiosum (MC) infections is critical in atopic dermatitis (AD) management. This post hoc analysis assessed the efficacy and safety of berdazimer gel, 10.3% (topical, antiviral, nitric oxide\u2013releasing medication) versus vehicle in MC patients with or without AD.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Three Phase 3, multicenter, randomized, double\u2010blind, vehicle\u2010controlled, parallel\u2010group trials (B\u2010SIMPLE[<jats:italic>b<\/jats:italic>erdazimer <jats:italic>s<\/jats:italic>odium <jats:italic>i<\/jats:italic>n <jats:italic>m<\/jats:italic>olluscum <jats:italic>p<\/jats:italic>atients with <jats:italic>le<\/jats:italic>sions]1, \u22122, \u22124) enrolled patients 6\u2009months and older with 3\u201370 mollusca. Berdazimer or vehicle was applied once daily to all MC lesions for 12\u2009weeks. Data from three Phase 3 studies were integrated for subgroup efficacy and safety assessments using several weighted meta\u2010analysis approaches. Patients with concurrent AD or a history of AD\/eczema were categorized as AD+ subgroup (AD\u2212 when absent). Primary efficacy endpoint: complete lesion clearance at Week 12. Safety endpoints included adverse events (AEs) through Week 24 and local skin reactions through Week 12.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 1598 enrolled patients, 209 (13.1%) were AD+. Baseline mean lesion counts were greater in AD+ (26.4) than AD\u2212 (19.3). Complete clearance rates were higher at Week 12 for berdazimer compared with vehicle in AD+ (<jats:italic>n<\/jats:italic>\u2009=\u2009209; 35.0% vs. 27.4%; odds ratio [OR], 1.3; 95% CI, 0.7\u20132.5) and AD\u2212 (<jats:italic>n<\/jats:italic>\u2009=\u20091389; 29.1% vs. 18.9%; OR 1.8; 95% CI 1.4\u20132.4) subgroups. AEs in AD+ were application\u2010site pain (21.6% with berdazimer vs. 11.9% with vehicle), dermatitis (12.8% vs. 2.4%), and erythema (9.6% vs. 7.1%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Berdazimer gel showed favorable efficacy regardless of AD status. Berdazimer\u2010induced erythema may be indistinguishable from AD symptoms or with inflammatory response upon resolution of molluscum.<\/jats:p><\/jats:sec>","DOI":"10.1111\/pde.15575","type":"journal-article","created":{"date-parts":[[2024,2,28]],"date-time":"2024-02-28T02:45:17Z","timestamp":1709088317000},"page":"438-444","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Berdazimer gel for molluscum contagiosum in patients with atopic dermatitis"],"prefix":"10.1111","volume":"41","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6187-6549","authenticated-orcid":false,"given":"Amy S.","family":"Paller","sequence":"first","affiliation":[{"name":"Department of Dermatology Northwestern University Feinberg School of Medicine and the Ann and Robert H. Lurie Children's Hospital  Chicago Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1295-9249","authenticated-orcid":false,"given":"Lawrence J.","family":"Green","sequence":"additional","affiliation":[{"name":"Department of Dermatology George Washington University School of Medicine  Washington DC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4274-7597","authenticated-orcid":false,"given":"Nanette","family":"Silverberg","sequence":"additional","affiliation":[{"name":"Department of Dermatology Icahn School of Medicine at Mount Sinai  New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-8244-7210","authenticated-orcid":false,"given":"Stephen","family":"Stripling","sequence":"additional","affiliation":[{"name":"Pediatric Department Coastal Pediatric Research  Charleston South Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7207-2810","authenticated-orcid":false,"given":"Martina","family":"Cartwright","sequence":"additional","affiliation":[{"name":"Novan, Inc.  Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5021-9201","authenticated-orcid":false,"given":"Carolyn","family":"Enloe","sequence":"additional","affiliation":[{"name":"Novan, Inc.  Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nick","family":"Wells","sequence":"additional","affiliation":[{"name":"Synteract  Hampshire UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7915-877X","authenticated-orcid":false,"given":"Elaine Kearney","family":"Kowalewski","sequence":"additional","affiliation":[{"name":"Gillings School of Global Public Health, University of North Carolina  Chapel Hill North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3614-1505","authenticated-orcid":false,"given":"Tomoko","family":"Maeda\u2010Chubachi","sequence":"additional","affiliation":[{"name":"Novan, Inc.  Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,2,27]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/s1473\u20103099(13)70109\u20109"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365\u20102133.2011.10464.x"},{"key":"e_1_2_11_4_1","volume-title":"Molluscum contagiosum","author":"Badri TG","year":"2023"},{"key":"e_1_2_11_5_1","volume-title":"Andrews' Diseases of the Skin","author":"Diseases V","year":"2020"},{"issue":"5","key":"e_1_2_11_6_1","first-page":"301","article-title":"Pediatric molluscum: an update","volume":"104","author":"Silverberg NB","year":"2019","journal-title":"Cutis"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaip.2023.04.052"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1590\/s0365\u201005962011000400006"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.3399\/bjgp15X688093"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamadermatol.2020.3238"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.2174\/1872213x11666170518114456"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ad.2018.01.007"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.niox.2004.04.005"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.4155\/fso.15.37"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12917\u2010019\u20101796\u2010x"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamadermatol.2022.2721"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2019.09.064"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.xjidi.2021.100019"},{"issue":"10","key":"e_1_2_11_19_1","first-page":"1100","article-title":"A phase 2 controlled study of SB206, a topical nitric oxide\u2010releasing drug for extragenital wart treatment","volume":"17","author":"Tyring SK","year":"2018","journal-title":"J Drugs Dermatol"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jid.2020.04.013"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.3390\/v15122360"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2023.09.066"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2012\u20102933"}],"container-title":["Pediatric Dermatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/pde.15575","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,14]],"date-time":"2024-05-14T15:29:48Z","timestamp":1715700588000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/pde.15575"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2,27]]},"references-count":22,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2024,5]]}},"alternative-id":["10.1111\/pde.15575"],"URL":"https:\/\/doi.org\/10.1111\/pde.15575","archive":["Portico"],"relation":{},"ISSN":["0736-8046","1525-1470"],"issn-type":[{"value":"0736-8046","type":"print"},{"value":"1525-1470","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,2,27]]},"assertion":[{"value":"2023-12-12","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-02-13","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-02-27","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}