Amy S Paller, Adelaide A Hebert, Mercedes E Gonzalez, Victoria Butners, Nancy Fitzgerald, Glenn Tabolt, David S Rubenstein, Stephen C Piscitelli
{"title":"Tapinarof乳膏在2岁以下患有广泛特应性皮炎的儿童患者中每日一次的最大使用量试验。","authors":"Amy S Paller, Adelaide A Hebert, Mercedes E Gonzalez, Victoria Butners, Nancy Fitzgerald, Glenn Tabolt, David S Rubenstein, Stephen C Piscitelli","doi":"10.1007/s40257-025-00929-9","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Tapinarof cream 1% is an aryl hydrocarbon receptor agonist approved by the US Food and Drug Administration to treat atopic dermatitis (AD) in patients down to age 2 years.</p><p><strong>Objective: </strong>The aim of this study was to evaluate the safety and pharmacokinetics of tapinarof cream 1% once daily (QD) in adolescents and children with extensive AD under maximal usage conditions.</p><p><strong>Methods: </strong>Patients with a validated Investigator Global Assessment scale for Atopic Dermatitis™ (vIGA-AD™) score ≥ 3 and body surface area (BSA) involvement ≥ 25% (ages 12-17 years) or ≥ 35% (ages 2-11 years) were enrolled into three age cohorts (2-6, 7-11, and 12-17 years) and received tapinarof cream 1% QD for 4 weeks.</p><p><strong>Results: </strong>Overall, 36 patients (12 per cohort) were enrolled; mean BSA affected was 42.8% (range 26.0-90.0) and mean Eczema Area and Severity Index (EASI) score was 23.8. At baseline, 28 patients (77.8%) had a vIGA-AD™ score of 3 (moderate). No-to-minimal tapinarof systemic exposure was observed (25% of post-treatment plasma samples were below the quantifiable limit of a highly sensitive assay [< 50 pg/mL]). Mean maximum plasma concentration (C<sub>max</sub>) was 2.44 ng/mL, and median time to C<sub>max</sub> was 2.9 h. Eight patients (22.2%) reported treatment-emergent adverse events (TEAEs), which were mild or moderate; only one patient discontinued due to two unrelated TEAEs. One case of mild folliculitis and no contact dermatitis occurred. Tapinarof was well tolerated, including on sensitive skin and extensor/flexural surfaces.</p><p><strong>Conclusion: </strong>Tapinarof cream exhibits highly favorable safety and pharmacokinetics in adolescents and children down to age 2 years with extensive AD.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT05186805.</p>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":" ","pages":""},"PeriodicalIF":8.6000,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Maximal Usage Trial of Tapinarof Cream 1% Once Daily in Pediatric Patients Down to 2 Years of Age with Extensive Atopic Dermatitis.\",\"authors\":\"Amy S Paller, Adelaide A Hebert, Mercedes E Gonzalez, Victoria Butners, Nancy Fitzgerald, Glenn Tabolt, David S Rubenstein, Stephen C Piscitelli\",\"doi\":\"10.1007/s40257-025-00929-9\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Tapinarof cream 1% is an aryl hydrocarbon receptor agonist approved by the US Food and Drug Administration to treat atopic dermatitis (AD) in patients down to age 2 years.</p><p><strong>Objective: </strong>The aim of this study was to evaluate the safety and pharmacokinetics of tapinarof cream 1% once daily (QD) in adolescents and children with extensive AD under maximal usage conditions.</p><p><strong>Methods: </strong>Patients with a validated Investigator Global Assessment scale for Atopic Dermatitis™ (vIGA-AD™) score ≥ 3 and body surface area (BSA) involvement ≥ 25% (ages 12-17 years) or ≥ 35% (ages 2-11 years) were enrolled into three age cohorts (2-6, 7-11, and 12-17 years) and received tapinarof cream 1% QD for 4 weeks.</p><p><strong>Results: </strong>Overall, 36 patients (12 per cohort) were enrolled; mean BSA affected was 42.8% (range 26.0-90.0) and mean Eczema Area and Severity Index (EASI) score was 23.8. At baseline, 28 patients (77.8%) had a vIGA-AD™ score of 3 (moderate). No-to-minimal tapinarof systemic exposure was observed (25% of post-treatment plasma samples were below the quantifiable limit of a highly sensitive assay [< 50 pg/mL]). Mean maximum plasma concentration (C<sub>max</sub>) was 2.44 ng/mL, and median time to C<sub>max</sub> was 2.9 h. Eight patients (22.2%) reported treatment-emergent adverse events (TEAEs), which were mild or moderate; only one patient discontinued due to two unrelated TEAEs. One case of mild folliculitis and no contact dermatitis occurred. Tapinarof was well tolerated, including on sensitive skin and extensor/flexural surfaces.</p><p><strong>Conclusion: </strong>Tapinarof cream exhibits highly favorable safety and pharmacokinetics in adolescents and children down to age 2 years with extensive AD.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT05186805.</p>\",\"PeriodicalId\":7706,\"journal\":{\"name\":\"American Journal of Clinical Dermatology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":8.6000,\"publicationDate\":\"2025-03-24\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"American Journal of Clinical Dermatology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s40257-025-00929-9\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"American Journal of Clinical Dermatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40257-025-00929-9","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
Maximal Usage Trial of Tapinarof Cream 1% Once Daily in Pediatric Patients Down to 2 Years of Age with Extensive Atopic Dermatitis.
Background: Tapinarof cream 1% is an aryl hydrocarbon receptor agonist approved by the US Food and Drug Administration to treat atopic dermatitis (AD) in patients down to age 2 years.
Objective: The aim of this study was to evaluate the safety and pharmacokinetics of tapinarof cream 1% once daily (QD) in adolescents and children with extensive AD under maximal usage conditions.
Methods: Patients with a validated Investigator Global Assessment scale for Atopic Dermatitis™ (vIGA-AD™) score ≥ 3 and body surface area (BSA) involvement ≥ 25% (ages 12-17 years) or ≥ 35% (ages 2-11 years) were enrolled into three age cohorts (2-6, 7-11, and 12-17 years) and received tapinarof cream 1% QD for 4 weeks.
Results: Overall, 36 patients (12 per cohort) were enrolled; mean BSA affected was 42.8% (range 26.0-90.0) and mean Eczema Area and Severity Index (EASI) score was 23.8. At baseline, 28 patients (77.8%) had a vIGA-AD™ score of 3 (moderate). No-to-minimal tapinarof systemic exposure was observed (25% of post-treatment plasma samples were below the quantifiable limit of a highly sensitive assay [< 50 pg/mL]). Mean maximum plasma concentration (Cmax) was 2.44 ng/mL, and median time to Cmax was 2.9 h. Eight patients (22.2%) reported treatment-emergent adverse events (TEAEs), which were mild or moderate; only one patient discontinued due to two unrelated TEAEs. One case of mild folliculitis and no contact dermatitis occurred. Tapinarof was well tolerated, including on sensitive skin and extensor/flexural surfaces.
Conclusion: Tapinarof cream exhibits highly favorable safety and pharmacokinetics in adolescents and children down to age 2 years with extensive AD.
期刊介绍：
The American Journal of Clinical Dermatology is dedicated to evidence-based therapy and effective patient management in dermatology. It publishes critical review articles and clinically focused original research covering comprehensive aspects of dermatological conditions. The journal enhances visibility and educational value through features like Key Points summaries, plain language summaries, and various digital elements, ensuring accessibility and depth for a diverse readership.
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