{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,8]],"date-time":"2026-03-08T23:08:38Z","timestamp":1773011318052,"version":"3.50.1"},"reference-count":49,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,4,12]],"date-time":"2024-04-12T00:00:00Z","timestamp":1712880000000},"content-version":"vor","delay-in-days":11,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Experimental Dermatology"],"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Hybrid trials are a new trend in dermatological research that leverage mobile health technologies to decentralize a subset of clinical trial elements and thereby reduce the number of in\u2010clinic visits. In a Phase I\/IIa randomized controlled hybrid trial, the safety and efficacy of an anti\u2010proliferative and anti\u2010inflammatory drug inhibiting cytosolic phospholipase A2 (AVX001) was tested using 1%, 3% or vehicle gel in 60 patients with actinic keratosis (AK) and assessed in\u2010clinic as well as remotely. Over the course of 12\u2009weeks, patients were assessed in\u2010clinic at baseline, end of treatment (EOT) and end of study (EOS), as well as 9 times remotely on a weekly to biweekly basis. Safety outcomes comprising local skin reactions (LSR; 0\u20135), adverse events (AE) and cosmesis, were graded in\u2010clinic and remotely using patient\u2010obtained smartphone photographs (PSPs) and questionnaires; efficacy was assessed in\u2010clinic based on clinically visible clearance of AK target area of &gt;50%. A total of 55 participants (91.7%) completed the treatment course. The average submission rate of PSPs was high (\u226585%), of which 93% were of sufficient quality. No serious AE were reported and only two experienced temporary LSR &gt;2 (scale 0\u20134) and cosmesis remained stable throughout the study. Based on the mild AE and LSR profile, daily application of AVX001 gel for 1\u2009month appears safe, tolerable, and cosmetically acceptable for use in patients with AK. At EOT, AVX001 achieved a subtle treatment response with clearance of AK target area of &gt;50% in 18% of patients. Remote and in\u2010clinic assessments of LSRs were in high agreement, suggesting that the use of mobile health technologies in early\u2010phase hybrid studies of AK does not compromise patient safety.<\/jats:p>","DOI":"10.1111\/exd.15068","type":"journal-article","created":{"date-parts":[[2024,4,13]],"date-time":"2024-04-13T04:14:31Z","timestamp":1712981671000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Mobile health technologies in an interventional hybrid study on actinic keratosis: Results from an early phase randomized controlled trial investigating the safety and efficacy of a cytosolic phospholipase <scp>A<\/scp>2 inhibitor gel in photodamaged skin"],"prefix":"10.1111","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9708-6717","authenticated-orcid":false,"given":"Vinzent Kevin","family":"Ortner","sequence":"first","affiliation":[{"name":"Department of Dermatology Copenhagen University Hospital, Bispebjerg and Frederiksberg  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kim","family":"Kilov","sequence":"additional","affiliation":[{"name":"Studies&amp;Me A\/S  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-8469-2760","authenticated-orcid":false,"given":"Alejandro Castillo","family":"Mondrag\u00f3n","sequence":"additional","affiliation":[{"name":"Studies&amp;Me A\/S  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gabriella","family":"Fredman","sequence":"additional","affiliation":[{"name":"Department of Dermatology Copenhagen University Hospital, Bispebjerg and Frederiksberg  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Silje Haukali","family":"Omland","sequence":"additional","affiliation":[{"name":"Department of Dermatology Copenhagen University Hospital, Bispebjerg and Frederiksberg  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ionela","family":"Manole","sequence":"additional","affiliation":[{"name":"Studies&amp;Me A\/S  Copenhagen Denmark"},{"name":"2nd Department of Dermatology Colentina Clinical Hospital  Bucharest Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charlotte Amalie Pind","family":"Laugesen","sequence":"additional","affiliation":[{"name":"Studies&amp;Me A\/S  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Signe","family":"Havsager","sequence":"additional","affiliation":[{"name":"Studies&amp;Me A\/S  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Berit","family":"Johansen","sequence":"additional","affiliation":[{"name":"Coegin Pharma AB  Lund Sweden"},{"name":"Department of Biology Norwegian University of Science and Technology (NTNU)  Trondheim Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tore","family":"Duvold","sequence":"additional","affiliation":[{"name":"Coegin Pharma AB  Lund Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7957-6285","authenticated-orcid":false,"given":"Ari P\u00e1ll","family":"Isberg","sequence":"additional","affiliation":[{"name":"Studies&amp;Me A\/S  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anders Daniel","family":"Andersen","sequence":"additional","affiliation":[{"name":"Studies&amp;Me A\/S  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John R.","family":"Zibert","sequence":"additional","affiliation":[{"name":"Studies&amp;Me A\/S  Copenhagen Denmark"},{"name":"Coegin Pharma AB  Lund Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Merete","family":"H\u00e6dersdal","sequence":"additional","affiliation":[{"name":"Department of Dermatology Copenhagen University Hospital, Bispebjerg and Frederiksberg  Copenhagen Denmark"},{"name":"Department of Clinical Medicine, Faculty of Health and Medical Sciences University of Copenhagen  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,4,12]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.abd.2019.10.004"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jphotobiol.2019.04.007"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2133.2002.04720.x"},{"key":"e_1_2_12_5_1","volume-title":"StatPearls","author":"Marques E","year":"2022"},{"key":"e_1_2_12_6_1","first-page":"335","article-title":"Actinic keratosis: how to differentiate the good from the bad ones?","volume":"16","author":"Quaedvlieg PJF","year":"2006","journal-title":"Eur J Dermatol"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamadermatol.2022.1034"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1177\/0394632017697719"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.17632"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1684\/ejd.2009.0706"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.15107"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2021.02.082"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2022.04.013"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.13180"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1097\/DSS.0000000000003677"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.det.2019.02.004"},{"key":"e_1_2_12_17_1","doi-asserted-by":"publisher","DOI":"10.1159\/000529369"},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.3390\/cancers10100348"},{"key":"e_1_2_12_19_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13075-018-1794-6"},{"key":"e_1_2_12_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1476-5381.2012.02114.x"},{"key":"e_1_2_12_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.14128"},{"key":"e_1_2_12_22_1","doi-asserted-by":"publisher","DOI":"10.3390\/biom10101402"},{"key":"e_1_2_12_23_1","first-page":"154","article-title":"Review of silicone gel sheeting and silicone gel for the prevention of hypertrophic scars and keloids","volume":"29","author":"Hsu K\u2010C","year":"2017","journal-title":"Wounds"},{"key":"e_1_2_12_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijpharm.2022.122111"},{"key":"e_1_2_12_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacbts.2021.01.011"},{"key":"e_1_2_12_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2014.07.061"},{"key":"e_1_2_12_27_1","volume-title":"What is Digital Health?","author":"Health, C. for D. and R","year":"2020"},{"key":"e_1_2_12_28_1","first-page":"663","article-title":"Randomized controlled trials: part 17 of a series on evaluation of scientific publications","volume":"108","author":"Kabisch M","year":"2011","journal-title":"Dtsch \u00c4rztebl Int"},{"key":"e_1_2_12_29_1","volume-title":"Guidance on the Implementation of Decentralised Elements in Clinical Trials with Medicinal Products is Now Available"},{"key":"e_1_2_12_30_1","volume-title":"Facilitating Decentralised Clinical Trials in the EU","author":"EMA","year":"2022"},{"key":"e_1_2_12_31_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2022.101561"},{"key":"e_1_2_12_32_1","unstructured":"Definition of Phase I\/II Clinical Trial \u2013 NCI Dictionary of Cancer Terms \u2013 NCI; 2011. Accessed September 8 2023.https:\/\/www.cancer.gov\/publications\/dictionaries\/cancer\u2010terms\/def\/phase\u2010i\u2010ii\u2010clinical\u2010trial"},{"key":"e_1_2_12_33_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1541-0420.2006.00685.x"},{"key":"e_1_2_12_34_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijerph19063553"},{"key":"e_1_2_12_35_1","doi-asserted-by":"publisher","DOI":"10.1007\/s43441-022-00412-1"},{"key":"e_1_2_12_36_1","doi-asserted-by":"publisher","DOI":"10.1159\/000506418"},{"key":"e_1_2_12_37_1","first-page":"V05200378","article-title":"Decentralised clinical trials","volume":"183","author":"Ali Z","year":"2021","journal-title":"Ugeskr Laeger"},{"key":"e_1_2_12_38_1","unstructured":"Mobile Devices in the Nordics.Statista. Accessed September 8 2023.https:\/\/www.statista.com\/topics\/7189\/mobile\u2010devices\u2010in\u2010the\u2010nordics\/"},{"key":"e_1_2_12_39_1","unstructured":"Decentralised Clinical Trials. Healthcare Denmark. Accessed September 8 2023.https:\/\/www.healthcaredenmark.dk\/healthcare\u2010in\u2010denmark\/population\u2010health\u2010management\/decentralised\u2010clinical\u2010trials\/"},{"key":"e_1_2_12_40_1","doi-asserted-by":"publisher","DOI":"10.1111\/srt.13136"},{"key":"e_1_2_12_41_1","doi-asserted-by":"publisher","DOI":"10.2196\/24766"},{"key":"e_1_2_12_42_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.17587"},{"key":"e_1_2_12_43_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2022-061012"},{"key":"e_1_2_12_44_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13555-014-0059-9"},{"key":"e_1_2_12_45_1","unstructured":"Accessed August 17 2023.https:\/\/patents.google.com\/patent\/WO2018055058A1\/en?oq=ep2017%2f073951"},{"key":"e_1_2_12_46_1","unstructured":"Answer piping \u2013 Google Surveys Help. Accessed September 8 2023.https:\/\/support.google.com\/surveys\/answer\/6004246?hl=en"},{"key":"e_1_2_12_47_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41371-022-00675-z"},{"key":"e_1_2_12_48_1","doi-asserted-by":"publisher","DOI":"10.1089\/tmj.2014.0221"},{"key":"e_1_2_12_49_1","doi-asserted-by":"publisher","DOI":"10.1111\/dth.15965"},{"key":"e_1_2_12_50_1","doi-asserted-by":"publisher","DOI":"10.1089\/tmj.2022.0405"}],"container-title":["Experimental Dermatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/exd.15068","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,4,30]],"date-time":"2024-04-30T05:35:24Z","timestamp":1714455324000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/exd.15068"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,4]]},"references-count":49,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2024,4]]}},"alternative-id":["10.1111\/exd.15068"],"URL":"https:\/\/doi.org\/10.1111\/exd.15068","archive":["Portico"],"relation":{},"ISSN":["0906-6705","1600-0625"],"issn-type":[{"value":"0906-6705","type":"print"},{"value":"1600-0625","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,4]]},"assertion":[{"value":"2024-01-29","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-03-19","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-04-12","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e15068"}}