{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T19:09:11Z","timestamp":1760123351217,"version":"3.37.3"},"reference-count":19,"publisher":"Springer Science and Business Media LLC","issue":"12","license":[{"start":{"date-parts":[[2024,11,22]],"date-time":"2024-11-22T00:00:00Z","timestamp":1732233600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,11,22]],"date-time":"2024-11-22T00:00:00Z","timestamp":1732233600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"This study was sponsored by Gen \u0130la\u00e7 ve Sa\u011fl\u0131k \u00dcr\u00fcnleri A.\u015e."}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Dermatol Ther (Heidelb)"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Introduction<\/jats:title>\n                <jats:p>Topical therapies are used in almost all patients with psoriasis. A novel fixed topical combination cream (GN-037) with a lower concentration (0.0356%) of clobetasol 17-propionate (CP) was developed together with urea, salicylic acid, and retinoic acid to provide a better benefit\u2013risk ratio. The present multicenter randomized double-blind vehicle-controlled parallel group phase 2 study aimed to investigate the efficacy and safety of GN-037 in patients with mild-to-moderate plaque psoriasis (MMPP).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Patients (<jats:italic>n<\/jats:italic>\u2009=\u2009190) were randomized (2:2:1) to receive GN-037 or CP or vehicle (V) cream twice daily to a selected target body lesion for 4\u00a0weeks. The primary endpoint was treatment success defined as percentage of patients with at least two-grade improvement in Investigator\u2019s Global Assessment Score (IGA) and IGA score equal to 0 or 1 evaluated at weeks 2, 4, 6, and 8 in each arm compared with baseline. Treatment-emergent adverse events (TEAEs) and safety were evaluated throughout the study.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>GN-037 demonstrated statistically significant superiority over V throughout the study. At week 4, treatment success was achieved in 37.9% of patients in the GN-037 arm compared with 29.2% and 9.1% in the CP and V arms, respectively. At least two-grade improvement compared with baseline was achieved by 57.6%, 72.7%, and 80.3% of the patients in the GN-037 arm for erythema, plaque elevation, and scaling, respectively. The mean changes in affected BSA were \u22122.1\u2009\u00b1\u20092.9, \u22121.8\u2009\u00b1\u20092.4, and \u22120.5\u2009\u00b1\u20091.6 in the GN-037, CP, and V arms, respectively. The TEAEs were similar among the arms and the most frequently observed TEAEs were Psoriasis Area and Severity Index (PASI) increase in all arms.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>GN-037 was more effective than V in achieving primary and all secondary endpoints throughout the study. Safety data did not reveal any new safety concerns with the combination cream product. Therefore, 4\u00a0weeks of GN-037 treatment demonstrated an excellent efficacy and safety profile in patients with MMPP.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial Registration number<\/jats:title>\n                <jats:p>ClinicalTrials.gov identifier, NCT05706870.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s13555-024-01301-1","type":"journal-article","created":{"date-parts":[[2024,11,22]],"date-time":"2024-11-22T19:35:47Z","timestamp":1732304147000},"page":"3337-3350","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["A Multicenter Randomized Double-Blind Vehicle-Controlled Parallel Group Phase 2 Study Evaluating the Efficacy and Safety of GN-037 Cream in Patients with Mild-to-Moderate Plaque Psoriasis"],"prefix":"10.1007","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct05706870","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Burhan","family":"Engin","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M\u00fcge","family":"G\u00fcler \u00d6zden","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"\u00d6zge Sevil","family":"Karstarl\u0131 Bakay","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Selda Pelin","family":"Kartal","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"\u0130lkin","family":"Zindanc\u0131","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Salih Levent","family":"\u00c7\u0131nar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Recep","family":"Dursun","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gizem","family":"Pehlivan Uluta\u015f","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tu\u011fba \u00d6zk\u00f6k","family":"\u00d6zk\u00f6k Akbulut","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fatma Asl\u0131","family":"Hapa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emel","family":"B\u00fclb\u00fcl Ba\u015fkan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mehmet","family":"Meliko\u011flu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alg\u00fcn","family":"Polat Ekinci","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Neslihan","family":"Demirel \u00d6\u011f\u00fct","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pelin","family":"H\u0131zl\u0131","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zafer","family":"T\u00fcrko\u011flu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"\u00d6zlem Su","family":"K\u00fc\u00e7\u00fck","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zeynep","family":"Topkarc\u0131","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"\u00dcmit","family":"T\u00fcrsen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Filiz","family":"Canpolat","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hanife","family":"U\u00e7gun","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"\u015eirin","family":"Ya\u015far","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Selami Aykut","family":"Temiz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Asena \u00c7i\u011fdem","family":"Do\u011framac\u0131","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sedat","family":"Altu\u011f","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Serhat","family":"Kozlu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2681-8615","authenticated-orcid":false,"given":"Nadir","family":"Ulu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Server","family":"Serdaro\u011flu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,11,22]]},"reference":[{"issue":"2","key":"1301_CR1","doi-asserted-by":"publisher","first-page":"377","DOI":"10.1038\/jid.2012.339","volume":"133","author":"R Parisi","year":"2013","unstructured":"Parisi R, Symmons DP, Griffiths CE, Ashcroft DM, Identification and Management of Psoriasis and Associated Comorbidity (IMPACT) Project Team. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Investig Dermatol. 2013;133(2):377\u201385.","journal-title":"J Investig Dermatol"},{"issue":"12","key":"1301_CR2","doi-asserted-by":"publisher","first-page":"1559","DOI":"10.1001\/archderm.143.12.1559","volume":"143","author":"C Huerta","year":"2007","unstructured":"Huerta C, Rivero E, Garcia Rodriguez LA. Incidence and risk factors for psoriasis in the general population. Arch Dermatol. 2007;143(12):1559\u201365.","journal-title":"Arch Dermatol"},{"issue":"3","key":"1301_CR3","doi-asserted-by":"publisher","first-page":"460","DOI":"10.5114\/ada.2021.108445","volume":"39","author":"B Zhu","year":"2022","unstructured":"Zhu B, Jing M, Yu Q, Ge X, Yuan F, Shi L. Treatments in psoriasis: from standard pharmacotherapy to nanotechnology therapy. Postepy Dermatol Alergol. 2022;39(3):460\u201371.","journal-title":"Postepy Dermatol Alergol"},{"issue":"8","key":"1301_CR4","first-page":"891","volume":"146","author":"SK Kurd","year":"2010","unstructured":"Kurd SK, Troxel AB, Crits-Christoph P, Gelfand JM. The risk of depression, anxiety, and suicidality in patients with psoriasis: a population-based cohort study. Arch Dermatol. 2010;146(8):891\u20135.","journal-title":"Arch Dermatol"},{"issue":"3","key":"1301_CR5","doi-asserted-by":"publisher","first-page":"759","DOI":"10.1111\/bjd.15085","volume":"176","author":"H Alinia","year":"2017","unstructured":"Alinia H, Tuchayi SM, Smith JA, et\u00a0al. Long-term adherence to topical psoriasis treatment can be abysmal: a 1-year randomized intervention study using objective electronic adherence monitoring. Br J Dermatol. 2017;176(3):759\u201364.","journal-title":"Br J Dermatol"},{"issue":"4","key":"1301_CR6","doi-asserted-by":"publisher","first-page":"292","DOI":"10.1159\/000018390","volume":"200","author":"PC van de Kerkhof","year":"2000","unstructured":"van de Kerkhof PC, de Hoop D, de Korte J, Cobelens SA, Kuipers MV. Patient compliance and disease management in the treatment of psoriasis in the Netherlands. Dermatology. 2000;200(4):292\u20138.","journal-title":"Dermatology"},{"issue":"4","key":"1301_CR7","doi-asserted-by":"publisher","first-page":"607","DOI":"10.1016\/j.jaad.2005.12.021","volume":"55","author":"KK Brown","year":"2006","unstructured":"Brown KK, Rehmus WE, Kimball AB. Determining the relative importance of patient motivations for nonadherence to topical corticosteroid therapy in psoriasis. J Am Acad Dermatol. 2006;55(4):607\u201313.","journal-title":"J Am Acad Dermatol"},{"issue":"6","key":"1301_CR8","doi-asserted-by":"publisher","first-page":"1009","DOI":"10.1016\/j.jaad.2008.08.028","volume":"59","author":"SR Feldman","year":"2008","unstructured":"Feldman SR, Horn EJ, Balkrishnan R, et\u00a0al. Psoriasis: improving adherence to topical therapy. J Am Acad Dermatol. 2008;59(6):1009\u201316.","journal-title":"J Am Acad Dermatol"},{"issue":"7","key":"1301_CR9","first-page":"643","volume":"16","author":"M Nakamura","year":"2017","unstructured":"Nakamura M, Abrouk M, Zhu H, Farahnik B, Koo J, Bhutani T. Update on the systemic risks of superpotent topical steroids. J Drugs Dermatol. 2017;16(7):643\u20138.","journal-title":"J Drugs Dermatol"},{"issue":"7","key":"1301_CR10","doi-asserted-by":"publisher","first-page":"1489","DOI":"10.1007\/s13555-023-00939-7","volume":"13","author":"Z Sezer","year":"2023","unstructured":"Sezer Z, Inal A, Cinar SL, et\u00a0al. Safety and efficacy of a novel combination cream (GN-037) in healthy volunteers and patients with plaque psoriasis: a phase 1 trial. Dermatol Ther (Heidelb). 2023;13(7):1489\u2013501.","journal-title":"Dermatol Ther (Heidelb)"},{"issue":"Suppl 3","key":"1301_CR11","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1111\/j.1468-3083.2012.04518.x","volume":"26","author":"C Paul","year":"2012","unstructured":"Paul C, Gallini A, Archier E, et\u00a0al. Evidence-based recommendations on topical treatment and phototherapy of psoriasis: systematic review and expert opinion of a panel of dermatologists. J Eur Acad Dermatol Venereol. 2012;26(Suppl 3):1\u201310.","journal-title":"J Eur Acad Dermatol Venereol"},{"issue":"1","key":"1301_CR12","doi-asserted-by":"publisher","DOI":"10.1111\/dth.12780","volume":"32","author":"C B\u00f6rjesson","year":"2019","unstructured":"B\u00f6rjesson C, Guinard E, Tauber M, et\u00a0al. Compounded topical preparations in plaque psoriasis: still a place for it in 2018? Dermatol Ther. 2019;32(1): e12780.","journal-title":"Dermatol Ther"},{"issue":"18","key":"1301_CR13","doi-asserted-by":"publisher","first-page":"1899","DOI":"10.1056\/NEJMra041320","volume":"352","author":"MP Sch\u00f6n","year":"2005","unstructured":"Sch\u00f6n MP, Boehncke WH. Psoriasis. N Engl J Med. 2005;352(18):1899\u2013912.","journal-title":"N Engl J Med"},{"issue":"6","key":"1301_CR14","doi-asserted-by":"publisher","first-page":"1905","DOI":"10.1007\/s13555-021-00611-y","volume":"11","author":"J Piquero-Casals","year":"2021","unstructured":"Piquero-Casals J, Morgado-Carrasco D, Granger C, Trull\u00e0s C, Jes\u00fas-Silva A, Krutmann J. Urea in dermatology: a review of its emollient, moisturizing, keratolytic, skin barrier enhancing and antimicrobial properties. Dermatol Ther (Heidelb). 2021;11(6):1905\u201315.","journal-title":"Dermatol Ther (Heidelb)"},{"issue":"5","key":"1301_CR15","doi-asserted-by":"publisher","first-page":"1717","DOI":"10.1007\/s13555-021-00591-z","volume":"11","author":"S Sidgiddi","year":"2021","unstructured":"Sidgiddi S, Naqvi SMH, Shenoy M, et\u00a0al. Efficacy and safety of novel formulation of clobetasol propionate 0.025% cream in Indian moderate-to-severe psoriasis patients: phase-2a, randomized 3-arm study. Dermatol Ther (Heidelb). 2021;11(5):1717\u201332.","journal-title":"Dermatol Ther (Heidelb)."},{"issue":"2","key":"1301_CR16","first-page":"22","volume":"13","author":"JQ Del Rosso","year":"2020","unstructured":"Del Rosso JQ. Topical corticosteroid therapy for psoriasis\u2014a review of clobetasol propionate 0.025% cream and the clinical relevance of penetration modification. J Clin Aesthet Dermatol. 2020;13(2):22\u20139.","journal-title":"J Clin Aesthet Dermatol."},{"issue":"4","key":"1301_CR17","doi-asserted-by":"publisher","first-page":"523","DOI":"10.1517\/14728214.2013.861418","volume":"18","author":"DN Kivelevitch","year":"2013","unstructured":"Kivelevitch DN, Hebeler KR, Patel M, Menter A. Emerging topical treatments for psoriasis. Expert Opin Emerg Drugs. 2013;18(4):523\u201332.","journal-title":"Expert Opin Emerg Drugs"},{"issue":"3","key":"1301_CR18","first-page":"CD005028","volume":"2013","author":"AR Mason","year":"2013","unstructured":"Mason AR, Mason J, Cork M, Dooley G, Hancock H. Topical treatments for chronic plaque psoriasis. Cochrane Database Syst Rev. 2013;2013(3):CD005028.","journal-title":"Cochrane Database Syst Rev"},{"issue":"Suppl 1","key":"1301_CR19","doi-asserted-by":"publisher","first-page":"35","DOI":"10.1111\/jdv.17053","volume":"35","author":"M Lebwohl","year":"2021","unstructured":"Lebwohl M, Tha\u00e7i D, Warren RB. Addressing challenges associated with long-term topical treatment and benefits of proactive management in patients with psoriasis. J Eur Acad Dermatol Venereol. 2021;35(Suppl 1):35\u201341.","journal-title":"J Eur Acad Dermatol Venereol"}],"container-title":["Dermatology and Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s13555-024-01301-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s13555-024-01301-1\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s13555-024-01301-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,29]],"date-time":"2024-11-29T04:49:31Z","timestamp":1732855771000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s13555-024-01301-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,11,22]]},"references-count":19,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2024,12]]}},"alternative-id":["1301"],"URL":"https:\/\/doi.org\/10.1007\/s13555-024-01301-1","relation":{},"ISSN":["2193-8210","2190-9172"],"issn-type":[{"type":"print","value":"2193-8210"},{"type":"electronic","value":"2190-9172"}],"subject":[],"published":{"date-parts":[[2024,11,22]]},"assertion":[{"value":"13 September 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"22 October 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"22 November 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Nadir Ulu and Serhat Kozlu report employment on Gen \u0130la\u00e7 ve Sa\u011fl\u0131k \u00dcr\u00fcnleri A.\u015e. Burhan Engin, M\u00fcge G\u00fcler \u00d6zden, \u00d6zge Sevil Karstarl\u0131 Bakay, Selda Pelin Kartal, \u0130lkin Zindanc\u0131, Salih Levent \u00c7\u0131nar, Recep Dursun, Gizem Pehlivan Uluta\u015f, Tu\u011fba \u00d6zk\u00f6k Akbulut, Fatma Asl\u0131 Hapa, Emel B\u00fclb\u00fcl Ba\u015fkan, Mehmet Meliko\u011flu, Alg\u00fcn Polat Ekinci, Neslihan Demirel \u00d6\u011f\u00fct, Pelin H\u0131zl\u0131, Zafer T\u00fcrko\u011flu, \u00d6zlem Su K\u00fc\u00e7\u00fck, Zeynep Topkarc\u0131, \u00dcmit T\u00fcrsen, Filiz Canpolat, Hanife U\u00e7gun, \u015eirin Ya\u015far, Selami Aykut Temiz, Asena \u00c7i\u011fdem Do\u011framac\u0131, Sedat Altu\u011f and Server Serdaro\u011flu have nothing to disclose.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"The trial was carried out according to the ethical standards of the Declaration of Helsinki and the International Conference on Harmonization of Good Clinical Practice Guidelines and its revisions. The study protocol was approved by the Ethics Committee for Clinical Trials of Istanbul University-Cerrahpasa, Istanbul, Turkey, and the Republic of Turkey. Written informed consent was provided from all patients before enrollment.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}