{"@context":{"@vocab":"https://cir.nii.ac.jp/schema/1.0/","rdfs":"http://www.w3.org/2000/01/rdf-schema#","dc":"http://purl.org/dc/elements/1.1/","dcterms":"http://purl.org/dc/terms/","foaf":"http://xmlns.com/foaf/0.1/","prism":"http://prismstandard.org/namespaces/basic/2.0/","cinii":"http://ci.nii.ac.jp/ns/1.0/","datacite":"https://schema.datacite.org/meta/kernel-4/","ndl":"http://ndl.go.jp/dcndl/terms/","jpcoar":"https://github.com/JPCOAR/schema/blob/master/2.0/"},"@id":"https://cir.nii.ac.jp/crid/1390001205190923904.json","@type":"Article","productIdentifier":[{"identifier":{"@type":"DOI","@value":"10.11340/skinresearch.6.5_504"}},{"identifier":{"@type":"NAID","@value":"130005404579"}},{"identifier":{"@type":"NAID","@value":"80018085115"}},{"identifier":{"@type":"URI","@value":"https://search.jamas.or.jp/link/ui/2008117137"}}],"dc:title":[{"@language":"ja","@value":"One-Year Efficacy and Safety of Adapalene Gel 0.1% gel in Japanese Patients with Acne Vulgaris"},{"@language":"en","@value":"One-Year Efficacy and Safety of Adapalene Gel 0.1% gel in Japanese Patients with Acne Vulgaris"}],"dc:language":"ja","description":[{"type":"abstract","notation":[{"@language":"en","@value":"Acne vulgaris is a chronic disease that may require long-term therapy for many patients to achieve the desired effect as well as to increase the likelihood of maintaining short-term improvements.  The aim of this study was to evaluate the long-term safety and efficacy profile of adapalene gel 0.1% in the treatment of Japanese patients with acne vulgaris when used once daily for up to 12 months.  A total of 446 male or female patients were enrolled in the study, 404 (91%) patients completing 6 months or more and  357 (80%) of patients completing the 12-months.  Treatment with adapalene was safe and well-tolerated when used for up to 12 months in Japanese patients with acne vulgaris.  Adverse events were mostly mild or moderate and were transient in nature.  The vast majority of adverse events occurred during the first two weeks of the study.  Nine patients (2.0%) had 13 serious adverse events; none were considered to be related to the study drug.  Eight patients (1.8%) had adverse events leading to discontinuation of the study drug that were characterized as related to study medication.  The therapeutic benefit of adapalene gel 0.1%, expressed as median percent reduction from baseline for total, inflammatory and non-inflammatory lesions, consistently observed after 3 months of treatment continue to improve after 6 and up to 12 months thus demonstrating the interest for many patients to continue treatment after the recommended 3 months period.  Patients also expressed high satisfaction about treatment outcomes at the end of the study.   These high satisfaction rates did increase during the course of the study and up to 12 months.  These findings strongly support the use of adapalene as a safe and effective treatment in the long term management (up to 12 months) of Japanese patients with acne vulgaris."},{"@language":"ja","@value":"尋常性ざ瘡は慢性疾患であるため，短期的な治療効果を維持するとともに，患者の期待に応える効果を得るためには長期間の治療を要する場合が多い。本試験は，日本人の尋常性ざ瘡患者に対し，アダパレンゲル0.1%を1日1回，最長12ヵ月間投与した場合の安全性及び有効性の評価を目的として実施した。446例の男女の被験者が組み入れられ，404例(91%)が6ヵ月間以上の投与を受け，357例(80%)が12ヵ月間の試験期間を完了した。尋常性ざ瘡患者に対する，最長12ヵ月間のアダパレン治療は高い安全性及び忍容性を示した。有害事象のほとんどが試験開始後2週間以内に生じた軽度又は中等度の一過性のものであった。9例(2.0%)，13件の重篤な有害事象が発現したものの，いずれも被験薬との因果関係はなしと評価された。8例(1.8%)に試験中止につながる有害事象が発現し，被験薬との因果関係ありと評価された。総皮疹数，炎症性皮疹数及び非炎症性皮疹数の減少率(中央値)により評価されたアダパレンゲル0.1%の治療効果は，いずれの皮疹数についても試験開始3ヵ月後以降も認められ，その後6ヵ月後，さらに12ヵ月後まで継続した。このことから，アダパレンによる尋常性ざ瘡の治療期間として推奨される3ヵ月間の治療後にも継続投与することの臨床的意義が示唆された。また，被験者は試験終了時に実施した調査において，治療に対する高い満足度を示した。この満足度は，12ヵ月の試験中，経時的に増加した。以上より，日本人の尋常性ざ瘡患者にアダパレンを12ヵ月にわたり長期に使用することは，安全かつ有効な治療であることが支持された。"}],"abstractLicenseFlag":"disallow"}],"creator":[{"@id":"https://cir.nii.ac.jp/crid/1410001205190923906","@type":"Researcher","personIdentifier":[{"@type":"NRID","@value":"9000257935554"}],"foaf:name":[{"@language":"ja","@value":"川島 眞"},{"@language":"en","@value":"Kawashima Makoto"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Department of Dermatology, Tokyo Women’s Medical University"},{"@language":"ja","@value":"東京女子医科大学皮膚科学教室"}]},{"@id":"https://cir.nii.ac.jp/crid/1410001205190923904","@type":"Researcher","personIdentifier":[{"@type":"NRID","@value":"9000345396145"}],"foaf:name":[{"@language":"ja","@value":"原田 昭太郎"},{"@language":"en","@value":"Harada Shotaro"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Department of Dermatology, NTT East Japan Kanto Hospital"},{"@language":"ja","@value":"NTT東日本関東病院皮膚科"}]},{"@id":"https://cir.nii.ac.jp/crid/1410001205190923905","@type":"Researcher","personIdentifier":[{"@type":"NRID","@value":"9000345396146"}],"foaf:name":[{"@language":"ja","@value":"Philippe Andres"},{"@language":"en","@value":"Andres Philippe"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Galderma R&D, Sophia-Antipolis"},{"@language":"ja","@value":"Galderma R&D, Sophia-Antipolis"}]},{"@id":"https://cir.nii.ac.jp/crid/1410001205190923907","@type":"Researcher","personIdentifier":[{"@type":"NRID","@value":"9000345396147"}],"foaf:name":[{"@language":"ja","@value":"宮地 良樹"},{"@language":"en","@value":"Miyachi Yoshiki"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Department of Dermatology, Kyoto University, Graduate School of Medicine"},{"@language":"ja","@value":"京都大学大学院医学研究科皮膚生命科学講座"}]}],"publication":{"publicationIdentifier":[{"@type":"PISSN","@value":"13471813"},{"@type":"EISSN","@value":"18839614"}],"prism:publicationName":[{"@language":"en","@value":"Hifu no kagaku"},{"@language":"ja","@value":"皮膚の科学"},{"@language":"en","@value":"Hifu no kagaku"},{"@language":"en","@value":"SKIN RESEARCH"},{"@language":"ja","@value":"皮膚の科学"}],"dc:publisher":[{"@language":"en","@value":"Meeting of Osaka Dermatological Association/Meeting of Keiji Dermatological Association"},{"@language":"ja","@value":"日本皮膚科学会大阪地方会・日本皮膚科学会京滋地方会"}],"prism:publicationDate":"2007","prism:volume":"6","prism:number":"5","prism:startingPage":"504","prism:endingPage":"512"},"url":[{"@id":"https://search.jamas.or.jp/link/ui/2008117137"}],"availableAt":"2007","foaf:topic":[{"@id":"https://cir.nii.ac.jp/all?q=%E3%82%A2%E3%83%80%E3%83%91%E3%83%AC%E3%83%B3","dc:title":"アダパレン"},{"@id":"https://cir.nii.ac.jp/all?q=%E9%95%B7%E6%9C%9F%E9%96%93","dc:title":"長期間"},{"@id":"https://cir.nii.ac.jp/all?q=%E5%A4%96%E7%94%A8%E3%83%AC%E3%83%81%E3%83%8E%E3%82%A4%E3%83%89","dc:title":"外用レチノイド"},{"@id":"https://cir.nii.ac.jp/all?q=%E5%B0%8B%E5%B8%B8%E6%80%A7%E3%81%96%E7%98%A1","dc:title":"尋常性ざ瘡"},{"@id":"https://cir.nii.ac.jp/all?q=adapalene","dc:title":"adapalene"},{"@id":"https://cir.nii.ac.jp/all?q=long-term","dc:title":"long-term"},{"@id":"https://cir.nii.ac.jp/all?q=topical%20retinoid","dc:title":"topical retinoid"},{"@id":"https://cir.nii.ac.jp/all?q=acne%20vulgaris","dc:title":"acne vulgaris"}],"relatedProduct":[{"@id":"https://cir.nii.ac.jp/crid/1390282679251982592","@type":"Article","relationType":["isCitedBy"],"jpcoar:relatedTitle":[{"@language":"en","@value":"Pharmacological and clinical profiles of adapalene (Differin) gel 0.1%"},{"@language":"ja","@value":"新規外用尋常性ざ瘡治療薬　アダパレンゲル（ディフェリンゲル０．１％）の薬理学的特性と臨床使用成績"},{"@value":"新薬紹介総説 新規外用尋常性ざ瘡治療薬 アダパレンゲル(ディフェリン ゲル0.1%)の薬理学的特性と臨床使用成績"},{"@language":"ja-Kana","@value":"シンヤク ショウカイ ソウセツ シンキ ガイヨウ ジンジョウセイザソウチリョウヤク アダパレンゲル ディフェリン ゲル 0 1 ノ ヤクリガクテキ トクセイ ト リンショウ シヨウ セイセキ"},{"@value":"Pharmacological and clinical profiles of adapalene (Differin®) gel 0.1%"}]},{"@id":"https://cir.nii.ac.jp/crid/1520572358129323520","@type":"Article","relationType":["isCitedBy"],"jpcoar:relatedTitle":[{"@value":"日本皮膚科学会ガイドライン 尋常性[ザ]瘡治療ガイドライン"},{"@language":"ja-Kana","@value":"ニホン ヒフカ ガッカイ ガイドライン ジンジョウセイ ザソウ チリョウ ガイドライン"}]}],"dataSourceIdentifier":[{"@type":"JALC","@value":"oai:japanlinkcenter.org:2001885368"},{"@type":"CIA","@value":"130005404579"},{"@type":"CIA","@value":"80018085115"}]}