{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T21:17:20Z","timestamp":1788556640812,"version":"build-2803163510"},"reference-count":31,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2022,12,9]],"date-time":"2022-12-09T00:00:00Z","timestamp":1670544000000},"content-version":"vor","delay-in-days":1318,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2019,2,27]],"date-time":"2019-02-27T00:00:00Z","timestamp":1551225600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2019,5,1]],"date-time":"2019-05-01T00:00:00Z","timestamp":1556668800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2019,5,1]]},"abstract":"<jats:title>Summary<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Once-daily topical oxymetazoline cream 1\u00b70% significantly reduced persistent facial erythema of rosacea in trials requiring live, static patient assessments.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To evaluate critically the methodology of clinical trials that require live, static patient assessments by determining whether assessment of erythema is different when reference to the baseline photograph is allowed.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In two identically designed, randomized, phase III trials, adults with persistent facial erythema of rosacea applied oxymetazoline or vehicle once daily. This phase IV study evaluated standardized digital facial photographs from the phase III trials to record \u2265 1-grade Clinician Erythema Assessment (CEA) improvement at 1, 3, 6, 9 and 12 h postdose.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Among 835 patients (oxymetazoline n =415, vehicle n =420), significantly greater proportions of patients treated with oxymetazoline vs. vehicle achieved \u2265 1-grade CEA improvement. For the comparison between phase IV study results and the original phase III analysis, when reference to baseline photographs was allowed while evaluating post-treatment photographs, the results for oxymetazoline were similar to results of the phase III trials (up to 85.7%), but a significantly lower proportion of vehicle recipients achieved \u2265 1-grade CEA improvement (up to 29.7% [phase 4] vs. 52.3% [phase 3]; P&amp;lt;0.001). In the phase IV study, up to 80\u00b72% of patients treated with oxymetazoline achieved at least moderate erythema improvement vs. up to 22\u00b79% of patients treated with vehicle. The association between patients\u2019 satisfaction with facial skin redness and percentage of erythema improvement was statistically significant.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Assessment of study photographs, with comparison to baseline, confirmed significant erythema reduction with oxymetazoline on the first day of application. Compared with the phase III trial results, significantly fewer vehicle recipients attained \u2265 1-grade CEA improvement, suggesting a mitigated vehicle effect. This methodology may improve the accuracy of clinical trials evaluating erythema severity.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1111\/bjd.17462","type":"journal-article","created":{"date-parts":[[2018,11,30]],"date-time":"2018-11-30T16:00:27Z","timestamp":1543593627000},"page":"1050-1057","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Use of an alternative method to evaluate erythema severity in a clinical trial: difference in vehicle response with evaluation of baseline and postdose photographs for effect of oxymetazoline cream 1\u00b70% for persistent erythema of rosacea in a phase IV study"],"prefix":"10.1093","volume":"180","author":[{"given":"L.F.","family":"Eichenfield","sequence":"first","affiliation":[{"name":"University of California San Diego CA U.S.A"},{"name":"Rady Children's Hospital San Diego CA U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.Q.","family":"Del Rosso","sequence":"additional","affiliation":[{"name":"JDR Dermatology Research\/Thomas Dermatology Las Vegas NV U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.K.L.","family":"Tan","sequence":"additional","affiliation":[{"name":"Windsor Clinical Research Inc. Windsor ON Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.A.","family":"Hebert","sequence":"additional","affiliation":[{"name":"UTHealth McGovern Medical School Department of Dermatology Houston TX U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.F.","family":"Webster","sequence":"additional","affiliation":[{"name":"Webster Dermatology, P.A. Hockessin DE U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Harper","sequence":"additional","affiliation":[{"name":"Dermatology and Skin Care Center of Birmingham Birmingham AL U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H.E.","family":"Baldwin","sequence":"additional","affiliation":[{"name":"The Acne Treatment and Research Center Morristown NJ U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.H.","family":"Kircik","sequence":"additional","affiliation":[{"name":"DermResearch, PLLC Louisville KY U.S.A"},{"name":"Icahn School of Medicine at Mount Sinai New York NY U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Stein-Gold","sequence":"additional","affiliation":[{"name":"Henry Ford Health System West Bloomfield MI U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Kaoukhov","sequence":"additional","affiliation":[{"name":"Allergan plc Irvine CA U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N.","family":"Alvandi","sequence":"additional","affiliation":[{"name":"Allergan plc Irvine CA U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2019,5,1]]},"reference":[{"key":"2023083116104675400_bjd17462-bib-0001","first-page":"26","article-title":"Advances in understanding and managing rosacea: part 2: the central role, evaluation, and medical management of diffuse and persistent facial erythema of rosacea","volume":"5","author":"Del Rosso","year":"2012","journal-title":"J Clin Aesthet Dermatol"},{"key":"2023083116104675400_bjd17462-bib-0002","doi-asserted-by":"crossref","first-page":"526","DOI":"10.1111\/1346-8138.13166","article-title":"Prognosis of 234 rosacea patients according to clinical subtype: the significance of central facial erythema in the prognosis of rosacea","volume":"43","author":"Lee","year":"2016","journal-title":"J 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