Jimmy Dhillon, Aryan Mahajan, Joy Xie, Madeline Tchack, Babar K Rao
{"title":"罗氟司特与脂溢性皮炎治疗的变化。","authors":"Jimmy Dhillon, Aryan Mahajan, Joy Xie, Madeline Tchack, Babar K Rao","doi":"10.1177/10600280251355662","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>This article reviews clinical trial data that assess the safety, efficacy, and clinical application of roflumilast, a phosphodiesterase-4 inhibitor, for the treatment of seborrheic dermatitis.</p><p><strong>Data sources: </strong>A review of the literature was conducted in MEDLINE (Pubmed) and Clinicaltrials.gov from January 1, 1950 to April 13, 2025 using the search terms: \"Roflumilast\" and \"seborrheic dermatitis.\"</p><p><strong>Study selection and data extraction: </strong>Relevant articles in English relating to the safety, efficacy, pharmacodynamics, and pharmacokinetics were included.</p><p><strong>Data synthesis: </strong>In one phase IIa clinical trial, 73.8% of patients treated with roflumilast achieved Investigator Global Assessment (IGA) success, compared with 40.9% in the vehicle group at 8 weeks (<i>P</i> < 0.001). A phase III trial found 79.5% of patients in the roflumilast group achieved IGA success at week 8, compared with 58.0% in the vehicle group (<i>P</i> < 0.001). Furthermore, there were statistically significant reductions in erythema, scaling, and itch severity in the roflumilast group. Roflumilast was well tolerated, with adverse events comparable with vehicle foam.Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:Roflumilast is the first phosphodiesterase-4 inhibitor approved by the Food and Drug Administration for the treatment of seborrheic dermatitis. Based on 2 clinical trials, roflumilast has a positive safety profile, is efficacious, and is easy to apply, highlighting its utility in treating seborrheic dermatitis.</p><p><strong>Conclusion: </strong>Roflumilast is effective in treating seborrheic dermatitis. Future trials should compare its safety and efficacy with other drugs.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251355662"},"PeriodicalIF":2.3000,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Roflumilast and the Changing Landscape of Seborrheic Dermatitis Treatment.\",\"authors\":\"Jimmy Dhillon, Aryan Mahajan, Joy Xie, Madeline Tchack, Babar K Rao\",\"doi\":\"10.1177/10600280251355662\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>This article reviews clinical trial data that assess the safety, efficacy, and clinical application of roflumilast, a phosphodiesterase-4 inhibitor, for the treatment of seborrheic dermatitis.</p><p><strong>Data sources: </strong>A review of the literature was conducted in MEDLINE (Pubmed) and Clinicaltrials.gov from January 1, 1950 to April 13, 2025 using the search terms: \\\"Roflumilast\\\" and \\\"seborrheic dermatitis.\\\"</p><p><strong>Study selection and data extraction: </strong>Relevant articles in English relating to the safety, efficacy, pharmacodynamics, and pharmacokinetics were included.</p><p><strong>Data synthesis: </strong>In one phase IIa clinical trial, 73.8% of patients treated with roflumilast achieved Investigator Global Assessment (IGA) success, compared with 40.9% in the vehicle group at 8 weeks (<i>P</i> < 0.001). A phase III trial found 79.5% of patients in the roflumilast group achieved IGA success at week 8, compared with 58.0% in the vehicle group (<i>P</i> < 0.001). Furthermore, there were statistically significant reductions in erythema, scaling, and itch severity in the roflumilast group. Roflumilast was well tolerated, with adverse events comparable with vehicle foam.Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:Roflumilast is the first phosphodiesterase-4 inhibitor approved by the Food and Drug Administration for the treatment of seborrheic dermatitis. Based on 2 clinical trials, roflumilast has a positive safety profile, is efficacious, and is easy to apply, highlighting its utility in treating seborrheic dermatitis.</p><p><strong>Conclusion: </strong>Roflumilast is effective in treating seborrheic dermatitis. 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Roflumilast and the Changing Landscape of Seborrheic Dermatitis Treatment.
Objective: This article reviews clinical trial data that assess the safety, efficacy, and clinical application of roflumilast, a phosphodiesterase-4 inhibitor, for the treatment of seborrheic dermatitis.
Data sources: A review of the literature was conducted in MEDLINE (Pubmed) and Clinicaltrials.gov from January 1, 1950 to April 13, 2025 using the search terms: "Roflumilast" and "seborrheic dermatitis."
Study selection and data extraction: Relevant articles in English relating to the safety, efficacy, pharmacodynamics, and pharmacokinetics were included.
Data synthesis: In one phase IIa clinical trial, 73.8% of patients treated with roflumilast achieved Investigator Global Assessment (IGA) success, compared with 40.9% in the vehicle group at 8 weeks (P < 0.001). A phase III trial found 79.5% of patients in the roflumilast group achieved IGA success at week 8, compared with 58.0% in the vehicle group (P < 0.001). Furthermore, there were statistically significant reductions in erythema, scaling, and itch severity in the roflumilast group. Roflumilast was well tolerated, with adverse events comparable with vehicle foam.Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:Roflumilast is the first phosphodiesterase-4 inhibitor approved by the Food and Drug Administration for the treatment of seborrheic dermatitis. Based on 2 clinical trials, roflumilast has a positive safety profile, is efficacious, and is easy to apply, highlighting its utility in treating seborrheic dermatitis.
Conclusion: Roflumilast is effective in treating seborrheic dermatitis. Future trials should compare its safety and efficacy with other drugs.
期刊介绍：
Annals of Pharmacotherapy (AOP) is a peer-reviewed journal that advances pharmacotherapy throughout the world by publishing high-quality research and review articles to achieve the most desired health outcomes.The articles provide cutting-edge information about the most efficient, safe and cost-effective pharmacotherapy for the treatment and prevention of various illnesses. This journal is a member of the Committee on Publication Ethics (COPE). Average time from submission to first decision: 14 days
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