{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T02:25:37Z","timestamp":1790821537821,"version":"4.1.0"},"reference-count":67,"publisher":"MDPI AG","issue":"18","license":[{"start":{"date-parts":[[2023,9,20]],"date-time":"2023-09-20T00:00:00Z","timestamp":1695168000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Cutanea Life Sciences, Wayne, Pennsylvania, USA"},{"name":"Maruho Co. Ltd., Kyoto, Japan"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["IJMS"],"abstract":"<jats:p>Facial seborrheic dermatitis (SD) is an inflammatory skin disease characterized by erythematous and scaly lesions on the skin with high sebaceous gland activity. The yeast Malassezia is regarded as a key pathogenic driver in this disease, but increased Staphylococcus abundances and barrier dysfunction are implicated as well. Here, we evaluated the antimicrobial peptide omiganan as a treatment for SD since it has shown both antifungal and antibacterial activity. A randomized, patient- and evaluator-blinded trial was performed comparing the four-week, twice daily topical administration of omiganan 1.75%, the comparator ketoconazole 2.00%, and placebo in patients with mild-to-moderate facial SD. Safety was monitored, and efficacy was determined by clinical scoring complemented with imaging. Microbial profiling was performed, and barrier integrity was assessed by trans-epidermal water loss and ceramide lipidomics. Omiganan was safe and well tolerated but did not result in a significant clinical improvement of SD, nor did it affect other biomarkers, compared to the placebo. Ketoconazole significantly reduced the disease severity compared to the placebo, with reduced Malassezia abundances, increased microbial diversity, restored skin barrier function, and decreased short-chain ceramide Cer[NSc34]. No significant decreases in Staphylococcus abundances were observed compared to the placebo. Omiganan is well tolerated but not efficacious in the treatment of facial SD. Previously established antimicrobial and antifungal properties of omiganan could not be demonstrated. Our multimodal characterization of the response to ketoconazole has reaffirmed previous insights into its mechanism of action.<\/jats:p>","DOI":"10.3390\/ijms241814315","type":"journal-article","created":{"date-parts":[[2023,9,20]],"date-time":"2023-09-20T21:26:32Z","timestamp":1695245192000},"page":"14315","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Treatment with the Topical Antimicrobial Peptide Omiganan in Mild-to-Moderate Facial Seborrheic Dermatitis versus Ketoconazole and Placebo: Results of a Randomized Controlled Proof-of-Concept Trial"],"prefix":"10.3390","volume":"24","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0986-3753","authenticated-orcid":false,"given":"Jannik","family":"Rousel","sequence":"first","affiliation":[{"name":"Centre for Human Drug Research, 2333 CL Leiden, The Netherlands"},{"name":"Leiden Academic Centre for Drug Research, Leiden University, 2333 CC Leiden, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3829-0037","authenticated-orcid":false,"given":"Mahdi","family":"Saghari","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research, 2333 CL Leiden, The Netherlands"},{"name":"Leiden University Medical Center, Leiden University, 2333 ZA Leiden, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2064-7501","authenticated-orcid":false,"given":"Lisa","family":"Pagan","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research, 2333 CL Leiden, The Netherlands"},{"name":"Leiden University Medical Center, Leiden University, 2333 ZA Leiden, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4981-6268","authenticated-orcid":false,"given":"Andreea","family":"N\u0103d\u0103ban","sequence":"additional","affiliation":[{"name":"Leiden Academic Centre for Drug Research, Leiden University, 2333 CC Leiden, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom","family":"Gambrah","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research, 2333 CL Leiden, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1333-2058","authenticated-orcid":false,"given":"Bart","family":"Theelen","sequence":"additional","affiliation":[{"name":"Westerdijk Fungal Biodiversity Institute, 3508 AD Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marieke L.","family":"de Kam","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research, 2333 CL Leiden, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-3142-7066","authenticated-orcid":false,"given":"Jorine","family":"Haakman","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research, 2333 CL Leiden, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7437-7746","authenticated-orcid":false,"given":"Hein E. C.","family":"van der Wall","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research, 2333 CL Leiden, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary L.","family":"Feiss","sequence":"additional","affiliation":[{"name":"Cutanea Life Sciences, Wayne, PA 19087, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tessa","family":"Niemeyer-van der Kolk","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research, 2333 CL Leiden, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7912-0918","authenticated-orcid":false,"given":"Jacobus","family":"Burggraaf","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research, 2333 CL Leiden, The Netherlands"},{"name":"Leiden Academic Centre for Drug Research, Leiden University, 2333 CC Leiden, The Netherlands"},{"name":"Leiden University Medical Center, Leiden University, 2333 ZA Leiden, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joke A.","family":"Bouwstra","sequence":"additional","affiliation":[{"name":"Leiden Academic Centre for Drug Research, Leiden University, 2333 CC Leiden, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Rissmann","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research, 2333 CL Leiden, The Netherlands"},{"name":"Leiden Academic Centre for Drug Research, Leiden University, 2333 CC Leiden, The Netherlands"},{"name":"Leiden University Medical Center, Leiden University, 2333 ZA Leiden, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martijn B. A.","family":"van Doorn","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research, 2333 CL Leiden, The Netherlands"},{"name":"Department of Dermatology, Erasmus Medical Centre, 3015 GD Rotterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,9,20]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"Borda, L.J., and Wikramanayake, T.C. (2015). Seborrheic Dermatitis and Dandruff: A Comprehensive Review. J. Clin. Investig. Dermatol., 3.","DOI":"10.13188\/2373-1044.1000019"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"991","DOI":"10.1111\/exd.14006","article-title":"Seborrheic Dermatitis\u2014Looking beyond Malassezia","volume":"28","author":"Wikramanayake","year":"2019","journal-title":"Exp. 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