{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,20]],"date-time":"2026-01-20T10:40:30Z","timestamp":1768905630341,"version":"3.49.0"},"reference-count":18,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2014,4,22]],"date-time":"2014-04-22T00:00:00Z","timestamp":1398124800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Pro Bono Bio Entrepreneur Ltd."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2015,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Rosacea subtype 1 (erythematotelangiectatic) is an inflammatory skin disease with limited treatment options. <jats:styled-content style=\"fixed-case\">TDT<\/jats:styled-content> 068, a topical drug\u2010free gel containing ultra\u2010deformable Sequessome vesicles, is registered for use in inflammatory skin conditions, but has not been investigated in rosacea.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>This postmarketing study aimed to substantiate the effects of <jats:styled-content style=\"fixed-case\">TDT<\/jats:styled-content> 068 in rosacea subtype 1.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients aged 18\u201385 scoring 6\u201315\/30 for the primary and secondary features of the rosacea standard grading system (<jats:styled-content style=\"fixed-case\">RSGS<\/jats:styled-content>) were enrolled. Following stratification (four females\/one male) patients were randomized (2:1) to receive <jats:styled-content style=\"fixed-case\">TDT<\/jats:styled-content> 068 or vehicle gel for 4\u00a0weeks. Efficacy was evaluated using the patient\u2010rated rosacea\u2010specific quality of life (R\u2010<jats:styled-content style=\"fixed-case\">QOL<\/jats:styled-content>) instrument and investigator\u2010rated <jats:styled-content style=\"fixed-case\">RSGS<\/jats:styled-content>. Adverse events (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s) were monitored throughout.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of the 61 randomized patients, 58 were eligible for the full analysis set per protocol. Baseline characteristics were balanced across the groups. R\u2010<jats:styled-content style=\"fixed-case\">QOL<\/jats:styled-content> symptom construct scores improved slightly from baseline to Week 4 in both groups (\u22120.04\u00a0\u00b1\u00a00.51 <jats:styled-content style=\"fixed-case\">TDT<\/jats:styled-content> 068 vs. \u22120.22\u00a0\u00b1\u00a00.59 vehicle; <jats:italic>P\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>0.1990). Changes in R\u2010<jats:styled-content style=\"fixed-case\">QOL<\/jats:styled-content> total, function and emotion construct scores at Week 4 were similar with <jats:styled-content style=\"fixed-case\">TDT<\/jats:styled-content> 068 and vehicle, but <jats:styled-content style=\"fixed-case\">TDT<\/jats:styled-content> 068 yielded numerically greater increases in total <jats:styled-content style=\"fixed-case\">RSGS<\/jats:styled-content> scores (\u20131.55\u00a0\u00b1\u00a01.83 vs. \u20130.75\u00a0\u00b1\u00a02.38 vehicle; <jats:italic>P\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>0.105). Non\u2010transient erythema improved significantly with <jats:styled-content style=\"fixed-case\">TDT<\/jats:styled-content> 068 at Week 4 (\u20130.34\u00a0\u00b1\u00a00.63 vs. \u20130.05\u00a0\u00b1\u00a00.51 vehicle; <jats:italic>P\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>0.044), with \u22651 grade improvement in 35% of patients (vs. 15% vehicle; <jats:italic>P\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>0.039). Numerically greater improvements in transient erythema and telangiectasia were also seen with <jats:styled-content style=\"fixed-case\">TDT<\/jats:styled-content> 068. Three treatment\u2010related <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s were reported but no serious <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s occurred.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>These data, based on investigator assessment, provide evidence for the good tolerability of drug\u2010free <jats:styled-content style=\"fixed-case\">TDT<\/jats:styled-content> 068 as well as modest improvements in the symptoms of erythematotelangiectatic rosacea.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdv.12520","type":"journal-article","created":{"date-parts":[[2014,4,22]],"date-time":"2014-04-22T12:14:44Z","timestamp":1398168884000},"page":"283-290","source":"Crossref","is-referenced-by-count":9,"title":["A multicentre, randomized, placebo\u2010controlled trial establishing the treatment effect of <scp>TDT<\/scp> 068, a topical formulation containing drug\u2010free ultra\u2010deformable phospholipid vesicles, on the primary features of erythematotelangiectatic rosacea"],"prefix":"10.1111","volume":"29","author":[{"given":"T.","family":"Luger","sequence":"first","affiliation":[{"name":"Department of Dermatology University Clinics M\u00fcnster Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"N.","family":"Peukert","sequence":"additional","affiliation":[{"name":"Dermatology Aestheso M\u00fcnster Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Rother","sequence":"additional","affiliation":[{"name":"IMR Partner GmbH Munich Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2014,4,22]]},"reference":[{"key":"e_1_2_6_2_1","first-page":"1","article-title":"Rosacea: update on management and emerging therapies","volume":"17","author":"Fallen RS","year":"2012","journal-title":"Skin Therapy 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