{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,8]],"date-time":"2026-07-08T16:22:30Z","timestamp":1783527750778,"version":"3.55.0"},"reference-count":36,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2018,5,22]],"date-time":"2018-05-22T00:00:00Z","timestamp":1526947200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Cosmetic Dermatology"],"published-print":{"date-parts":[[2019,2]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Acne vulgaris is a chronic inflammatory skin disease, commonly treated with topical or systemic drugs, according to the severity of the condition. Retinoids and antibiotic compounds are considered cornerstone approaches in this condition. However, low adherence to the therapy and the issue of bacterial resistance undermine the efficacy in the long term. Photodynamic therapy (<jats:styled-content style=\"fixed-case\">PDT<\/jats:styled-content>) with 20% aminolevulinic acid (<jats:styled-content style=\"fixed-case\">ALA<\/jats:styled-content>) has shown to be effective in the treatment of inflammatory acne. Skin tolerability, however, could be a limiting factor for a widespread use of this approach. A new formulation of 5% <jats:styled-content style=\"fixed-case\">ALA<\/jats:styled-content> in thermosetting gel has been recently available. This formulation allows a more convenient application procedure without occlusion and better and more efficient release of the active compound in comparison with traditional <jats:styled-content style=\"fixed-case\">ALA<\/jats:styled-content> formulations like creams or ointments.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study aim<\/jats:title><jats:p>To evaluate in a two\u2010center, assessor\u2010blinded, prospective, proof\u2010of\u2010concept study, the efficacy, and tolerability of red\u2010light (630\u00a0nm) <jats:styled-content style=\"fixed-case\">PDT<\/jats:styled-content> with a new 5\u2010<jats:styled-content style=\"fixed-case\">ALA<\/jats:styled-content> \u201clow\u2010dose\u201d topical gel formulation (5%) in the treatment of inflammatory mild\u2010to\u2010moderate acne vulgaris (<jats:styled-content style=\"fixed-case\">AV<\/jats:styled-content>).<\/jats:p><\/jats:sec><jats:sec><jats:title>Subjects and methods<\/jats:title><jats:p>A total of 35 subjects with moderate <jats:styled-content style=\"fixed-case\">AV<\/jats:styled-content> of the face (mean age: 24\u00a0\u00b1\u00a08\u00a0years, 13 men and 22 women) were enrolled, after their written informed consent. The primary outcome was the evolution of <jats:styled-content style=\"fixed-case\">GAG<\/jats:styled-content> (Global Acne Grade System) score at baseline and after an average of three, 630\u2010nm, 15\u2010minute, <jats:styled-content style=\"fixed-case\">PDT<\/jats:styled-content> sessions, performed every 2\u00a0weeks. <jats:styled-content style=\"fixed-case\">GAG<\/jats:styled-content> score was also calculated in a follow\u2010up visit 6\u00a0months after the last <jats:styled-content style=\"fixed-case\">PDT<\/jats:styled-content> session. Skin tolerability was assessed during <jats:styled-content style=\"fixed-case\">PDT<\/jats:styled-content> sessions with a patient\u2010reported discomfort level evaluation score from 0 (no discomfort at all) to 3 (severe discomfort).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>At baseline, the <jats:styled-content style=\"fixed-case\">GAG<\/jats:styled-content> score was 21\u00a0\u00b1\u00a06. After the last <jats:styled-content style=\"fixed-case\">PDT<\/jats:styled-content> session, the <jats:styled-content style=\"fixed-case\">GAG<\/jats:styled-content> score evaluated in a blinded fashion (digital photographs) was significantly reduced to 6.5\u00a0\u00b1\u00a05.7, representing a 70% reduction (<jats:italic>P<\/jats:italic>\u00a0=\u00a0.0001, Wilcoxon test; mean difference 14.9; 95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> of the difference: 12.1\u201017.6). At the follow\u2010up visit, the <jats:styled-content style=\"fixed-case\">GAG<\/jats:styled-content> score was 6.7\u00a0\u00b1\u00a06.8. The 5% <jats:styled-content style=\"fixed-case\">ALA<\/jats:styled-content> thermosetting gel Red\u2010light <jats:styled-content style=\"fixed-case\">PDT<\/jats:styled-content> was in general very well tolerated with a discomfort mean level score of 0.5\u00a0\u00b1\u00a01.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This proof\u2010of\u2010concept study supports the efficacy of 5% <jats:styled-content style=\"fixed-case\">ALA<\/jats:styled-content> thermosetting gel red\u2010light <jats:styled-content style=\"fixed-case\">PDT<\/jats:styled-content> in inflammatory acne of the face with a relevant clinical improvement of inflammatory lesions with a very good tolerability profile. Clinical improvement was maintained in the medium term (<jats:italic>Trial Registration Number: <jats:styled-content style=\"fixed-case\">ISRCTN<\/jats:styled-content>66066651<\/jats:italic>).<\/jats:p><\/jats:sec>","DOI":"10.1111\/jocd.12670","type":"journal-article","created":{"date-parts":[[2018,5,23]],"date-time":"2018-05-23T01:21:06Z","timestamp":1527038466000},"page":"156-162","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":37,"title":["The efficacy and tolerability of 5\u2010aminolevulinic acid 5% thermosetting gel photodynamic therapy (<scp>PDT<\/scp>) in the treatment of mild\u2010to\u2010moderate acne vulgaris. 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