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Res."],"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Oral lichen planus (OLP) is a chronic inflammatory disorder with limited topical treatment options and long-term corticosteroid dependency. This study investigates a novel atorvastatin-loaded hyalurosomal gel (ATV-Hyalugel) as a topical adjuvant to reduce systemic corticosteroid use in severe OLP. The objective of the study is\u00a0to develop, optimize, characterize ATV-Hyalugel and evaluate its clinical efficacy in a randomized controlled clinical\u00a0trial. ATV-loaded hyalurosomes (ATV-HAs) were prepared via thin-film hydration and optimized using an I-optimal mixture design (independent variables: phospholipid, Tween 80, and hyaluronic acid; responses: entrapment efficiency (EE%), particle size (PS), and zeta potential (ZP). The optimal formulation was incorporated into a chitosan gel, which was characterized for its pH, rheological behavior, and in-vitro drug release. Four weeks randomized controlled trial (n\u2009=\u200990) compared: group one received standard prednisolone (40\u202fmg\/day) while group two received half-dose prednisolone (20\u202fmg\/day) in combination with ATV-Hyalugel (topically, three times daily). Pain and ulcer scores were recorded weekly. Between-group comparisons were performed using the Mann\u2013Whitney U test (non-parametric; \u03b1\u2009=\u20090.05), and within-group improvement from baseline to Week 4 was assessed using the Kruskal\u2013Wallis test. Optimized ATV-HAs demonstrated high EE%\u00a0(79.1\u2009\u00b1\u20090.4%), uniform PS\u00a0(221.2\u2009\u00b1\u20095.1\u202fnm), and stable ZP\u00a0(\u201331.6\u2009\u00b1\u20090.2\u202fmV). ATV-Hyalugel exhibited mucosa-compatible pH (6.48\u2009\u00b1\u20090.2), pseudoplastic rheology, and a sustained release profile dominated by diffusion-driven kinetics. Clinically, group two achieved therapeutic equivalence to group one by Week 2 (p\u2009&gt;\u20090.05), despite receiving 50% less corticosteroid. Both groups showed significant symptom reduction from baseline to Week four (p\u2009&lt;\u20090.0001, Kruskal\u2013Wallis). No adverse events were reported with ATV-Hyalugel. ATV-Hyalugel enables a 50% corticosteroid dose reduction while maintaining clinical efficacy. Its favorable release kinetics and safety profile support its use as an innovative adjuvant therapy for severe OLP.<\/jats:p>","DOI":"10.1007\/s13346-025-01956-z","type":"journal-article","created":{"date-parts":[[2025,9,5]],"date-time":"2025-09-05T19:52:25Z","timestamp":1757101945000},"page":"1495-1516","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Exploring topical atorvastatin hyalurosomal gel as an adjuvant for reducing systemic corticosteroid dosage: a randomized clinical trial in severe oral lichen planus patients"],"prefix":"10.1007","volume":"16","author":[{"given":"Mahitab","family":"Elsayed","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aya","family":"Essawy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Radwa M.","family":"Ismail","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasmine","family":"Gamil","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed G.","family":"Hamed","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dalia","family":"Elsabaawy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6077-3441","authenticated-orcid":false,"given":"Eman","family":"Abdelhakeem","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Doaa","family":"Hegazy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Radwa M. 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