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試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000005536
受付番号 R000006566
試験名 アトピー性皮膚炎に対するプロアクティブ・マネージメントの有効性に関する前向き研究
一般公開日(本登録希望日) 2011/05/02
最終更新日 2016/08/09

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
試験名/Official scientific title of the study アトピー性皮膚炎に対するプロアクティブ・マネージメントの有効性に関する前向き研究 A randomized, open-label, parallel group study to evaluate the efficacy and safety of proactive management in pediatric subjects with moderate to severe atopic dermatitis
試験簡略名/Title of the study (Brief title) アトピー性皮膚炎に対するプロアクティブ・マネージメントの有効性に関する前向き研究 Efficacy and safety of proactive management in childhood atopic dermatitis
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition アトピー性皮膚炎 atopic dermatitis
疾患区分1/Classification by specialty
膠原病・アレルギー内科学/Clinical immunology 小児科学/Pediatrics
皮膚科学/Dermatology
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1 小児アトピー性皮膚炎に対するプロアクティブ療法の有効性と安全性に関して検討すること To evaluate the efficacy and safety of proactive management in pediatric subjects with atopic dermatitis.
目的2/Basic objectives2 安全性・有効性/Safety,Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 検証的/Confirmatory
試験の性質2/Trial characteristics_2 実務的/Pragmatic
試験のフェーズ/Developmental phase 第Ⅲ相/Phase III

評価/Assessment
主要アウトカム評価項目/Primary outcomes 割付けから24か月間の、受診毎のSCORADが20以下・50以下の患者の割合 Proportion of patients with SCORAD < 20 and SCORAD <50 at each study visit [Time Frame: 24 months]
副次アウトカム評価項目/Key secondary outcomes 割付け前、3、6、12、24ヵ月後の、調査票血中好酸球数、TARC、総IgE、特異的IgE(ダニ・スギ・卵白・牛乳)、及びサイトカイン(IL-4、IL-5、IL-13、IL-17、IL-33、IFN-γ)の測定、QOL調査票(CDLQI; Children’s dermatology life quality indexおよびDFI; The dermatitis family impact questionnaire)、局所有害事象の評価(皮膚菲薄化、皮膚線条、毛細血管拡張、酒さ様皮膚炎、皮膚感染症、ざ瘡等)その他重篤な副作用の有無、ACTH負荷試験、血中と唾液コルチゾール測定。 Decrease of total serum IgE after 3, 6, 12 and 24 months of treatment [Time Frame: at 3, 6, 12 and 24 months]
Change of immunological parameters (blood eosinophil count, TARC, specific IgE, IL-4, IL-5, IL-13, IL-17, IL-33, IFN-gamma) [Time Frame: at 3, 6, 12 and 24 months]
Quality of life (Children's dermatology life quality index and the dermatitis family impact questionnaire) at 6, 12 and 24 months.
Intensity of pruritus at each day as reported in the patient's diary by means of visual analogue scale (VAS)
Change of serum and salivary cortisol level at 6, 12 and 24 months [Time Frame: at 6, 12 and 24 months]
Local side effects on the skin, and incidence and severity of adverse event at each study visit [Time Frame: 24 months]

アウトカム評価項目には、可能な限り評価の時期の情報(例:投与開始から12週後など)も含めてください。また、評価項目としては、単に「安全性」「有効性」などとするのではなく、実際に測定する検査項目の名称を具体的にご記入ください。また、主要アウトカム評価項目は最も主要な1項目のみとし、2項目以降は副次アウトカム評価項目としてください。

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding オープンだが測定者がブラインド化されている/Open -but assessor(s) are blinded
コントロール/Control 実薬・標準治療対照/Active
層別化/Stratification はい/YES
動的割付/Dynamic allocation はい/YES
試験実施施設の考慮/Institution consideration
ブロック化/Blocking はい/YES
割付コードを知る方法/Concealment 中央登録/Central registration

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
行動・習慣/Behavior,custom
介入1/Interventions/Control_1 湿疹が改善した部位に対し週に2回程度、悪化しないことを確認しながら抗炎症薬を予防的に間欠塗布する方法 A proactive approach by using topical corticosteroids (i.e. twice-a-week) to all previously identified affected areas with confirmation of no exacerbation.
At exacerbation, patients apply topical corticosteroids everyday and subsequently return proactive application to any new skin areas where AD lesions have appeared.
介入2/Interventions/Control_2 ガイドラインに沿った通常治療、即ち湿疹が悪化したら抗炎症薬を塗布する方法 A conventional treatment using topical corticosteroids when flare.
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


介入1~10には、介入の期間(何日間投与、介入するか)、介入の量(投与量や線量など)、介入の回数、頻度など、内容を可能な限り詳しく記載してください。とくに、投薬や機器使用の介入の場合、期間は必ず含めてください。

適格性/Eligibility
年齢(下限)/Age-lower limit
0 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
15 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria (1)浜松医科大学通院中の3か月から15歳の男女。(2)医師に中等症から重症アトピー性皮膚炎と診断された者。 Eligible patients are boys and girls aged 3 months to 15 years with a diagnosis of atopic dermatitis according to the criteria of Hanifin and Rajka. The patients had moderate to severe AD as defined by the scoring system of Rajka and Langeland.
除外基準/Key exclusion criteria (1) 全身性ステロイド投与や免疫抑制薬、生物学的製剤を服薬した既往のあるもの。(2) 心疾患、肝疾患、腎疾患、内分泌・代謝性疾患の既往歴があり、現在治療中の者。 The exclusion criteria is as followed; (1) The patients receiving any additional systemic therapies included corticosteroids, nonsteroidal immunosuppressive agents or biological immunotherapy, (2) the patients who has a past history of cardiovascular disease, liver dysfunction, kidney disease and other current serious medical problems.
目標参加者数/Target sample size 50

責任研究者/Research contact person
責任研究者名/Name of lead principal investigator 福家辰樹 Tatsuki Fukuie
所属組織/Organization 浜松医科大学 Hamamatsu University School of Medicine
所属部署/Division name 小児科 Department of Pediatrics
住所/Address 静岡県浜松市東区半田山一丁目20番地1号 Handayama 1-20-1, Higashiku, Hamamatsushi,Shizuokaken, JAPAN
電話/TEL 053-435-2312
Email/Email fukuie-t@hama-med.ac.jp

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者名/Name of contact person 福家辰樹 Tatsuki Fukuie
組織名/Organization 浜松医科大学 Hamamatsu University School of Medicine
部署名/Division name 小児科 Department of Pediatrics
住所/Address 静岡県浜松市東区半田山一丁目20番地1号 Handayama 1-20-1, Higashiku, Hamamatsushi,Shizuokaken, JAPAN
電話/TEL 053-435-2312
試験のホームページURL/Homepage URL http://www.hama-med.ac.jp/
Email/Email fukuie-t@hama-med.ac.jp

実施責任組織/Sponsor
機関名/Institute その他 Division of Allergy, Department of Medical Specialties, National Center for Child Health and Development
機関名/Institute
(機関選択不可の場合)
国立成育医療研究センター 内科系診療部 アレルギー科
部署名/Department

実施責任組織に設定する適切な機関が存在しない場合は、「その他」を選択し、「機関名(機関選択不可の場合)」に実施責任組織の機関名、及び組織名を直接入力して下さい。

研究費提供組織/Funding Source
機関名/Organization 科学技術振興機構 Japan Society for the Promotion of Science (JSPS), Grant-in-Aid for Young Scientists B (No.23791165)
機関名/Organization
(機関選択不可の場合)
独立行政法人日本学術振興会 科学研究費助成事業(学術研究助成基金助成金)若手研究B (No.23791165)
組織名/Division
組織の区分/Category of Funding Organization 日本の官庁/Japanese Governmental office
研究費拠出国/Nationality of Funding Organization 日本 Japan

研究費提供組織に設定する適切な機関が存在しない場合は、「その他」を選択し、「機関名(機関選択不可の場合)」に研究費提供組織の機関名、及び組織名を直接入力して下さい。

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions 浜松医科大学附属病院(静岡県)

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2011 05 02

試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2011 03 31
登録・組入れ開始(予定)日/Anticipated trial start date
2011 05 01
フォロー終了(予定)日/Last follow-up date
2013 04 01
入力終了(予定)日/Date of closure to data entry
2013 05 01
データ固定(予定)日/Date trial data considered complete
2013 05 01
解析終了(予定)日/Date analysis concluded
2014 05 01

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 最終結果が公表されている/Published
結果掲載URL/URL releasing results http://www.ncbi.nlm.nih.gov/pubmed/27075216
主な結果/Results Abstract
Proactive therapy for atopic dermatitis (AD) effectively prevents exacerbation. However, its role in preventing subsequent sensitization to allergens has not been prospectively studied. We investigated whether proactive therapy for AD can effectively impact immunological parameters in a randomized, investigator-blinded, parallel group study. Thirty patients aged 3 months to 7 years with moderate to severe AD who had undergone an AD educational program were allocated to a proactive treatment group or a reactive treatment group. During the disease control period, patients in the proactive group performed intermittent preventive application of topical corticosteroid for 1 year. Changes in the severity scoring, quality of life measures and immunological parameters (serum thymus and activation regulated chemokine [TARC], total immunoglobulin E [IgE] and house dust mite-specific IgE levels) were evaluated and compared between the proactive and reactive treatment groups. Although the average topical corticosteroid ointment use per day in both groups was not significantly different, the severity and quality of life scores were significantly lower in the proactive group than in the reactive group at the final visit. In addition, compared with baseline levels, serum TARC levels remained significantly lower during proactive therapy, while house dust mite-specific IgE levels were significantly increased only in the reactive group. The results suggest that in addition to controlling the severity of AD, intermittent preventive administration of topical corticosteroids may prevent an increase in aeroallergen-specific IgE levels in patients with childhood AD. The use of TARC levels as a biomarker for AD remission is also supported.
Abstract
Proactive therapy for atopic dermatitis (AD) effectively prevents exacerbation. However, its role in preventing subsequent sensitization to allergens has not been prospectively studied. We investigated whether proactive therapy for AD can effectively impact immunological parameters in a randomized, investigator-blinded, parallel group study. Thirty patients aged 3 months to 7 years with moderate to severe AD who had undergone an AD educational program were allocated to a proactive treatment group or a reactive treatment group. During the disease control period, patients in the proactive group performed intermittent preventive application of topical corticosteroid for 1 year. Changes in the severity scoring, quality of life measures and immunological parameters (serum thymus and activation regulated chemokine [TARC], total immunoglobulin E [IgE] and house dust mite-specific IgE levels) were evaluated and compared between the proactive and reactive treatment groups. Although the average topical corticosteroid ointment use per day in both groups was not significantly different, the severity and quality of life scores were significantly lower in the proactive group than in the reactive group at the final visit. In addition, compared with baseline levels, serum TARC levels remained significantly lower during proactive therapy, while house dust mite-specific IgE levels were significantly increased only in the reactive group. The results suggest that in addition to controlling the severity of AD, intermittent preventive administration of topical corticosteroids may prevent an increase in aeroallergen-specific IgE levels in patients with childhood AD. The use of TARC levels as a biomarker for AD remission is also supported.
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2011 05 01
最終更新日/Last modified on
2016 08 09


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000006566
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006566


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