China Atopic Dermatitis Registry Study
China Atopic Dermatitis Registry Study: a Chinese Registry Study in Moderate-to-severe Atopic Dermatitis Patients Not Controlled by Topical Therapy
調査の概要
詳細な説明
Atopic dermatitis (AD) is a chronic recurrent inflammatory skin disease, resulting in itchy, red, and skin lesion. A survey conducted in 2014 in 39 tertiary hospitals of 15 provinces in mainland China has shown that the incidence of AD in outpatients (7.8%) has been raised in recent years.
Among topical therapy of AD, corticosteroids are first line therapy. In patients with extensive and severe dermatitis, topical therapy may be insufficient. Such patients may require the addition of either oral corticosteroid or systemic immunosuppressive therapy and even phototherapy. There is no clear recommendation treatment for each kind of patients with different severity yet and there are still huge unmet medical needs for treatment. There is not clear recommendation grade for these therapy in Chinese AD guideline and no published data to demonstrate current treatment situation in real clinical practise.
The goal of clinical registry study is to document the use and effectiveness of therapeutic interventions under real-life conditions. This study will help understand the clinical characteristics, treatment utilization, treatment patterns, as well as disease-related outcomes and cost among AD patients in China.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Jianzhong Zhang
- 電話番号:010-88325472
- メール:rmzjz@126.com
研究連絡先のバックアップ
- 名前:Ping Liu
- 電話番号:010-88325472
- メール:llppliuping@126.com
研究場所
-
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Beijing
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Beijing、Beijing、中国、100044
- 募集
- Peking University People's Hospital
-
コンタクト:
- Ping Liu
- 電話番号:010 88325472
- メール:llppliuping@126.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Age≥12;
- AD according to Williams diagnosis criteria (see Appendix 1);
- Moderate to severe AD that inadequately controlled by topical therapy
- Moderate-to-severe: SCORAD score≥25; or
- Inadequately controlled by topic therapies: Determined by physicians.
Exclusion Criteria:
- No.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Chinese moderate to severe atopic dermatitis patients not controlled by topical therapy
|
介入なし
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Physician evaluated effectiveness of Atopic Dermatitis therapies in real life
時間枠:At Month 12
|
Physician-reported outcome tool, SCORAD index, will be used to evaluate the objective severity of clinical signs of Atopic Dermatitis .
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At Month 12
|
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Patient-reported disease symptoms after Atopic Dermatitis therapies in real life
時間枠:At Month 12
|
Patient Oriented Eczema Measure (POEM) will be used to assess disease symptoms
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At Month 12
|
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Patient-reported severity of pruritus after Atopic Dermatitis therapies in real life
時間枠:At Month 12
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Peak Pruritus Numerical Rating Scale (NRS) will be used to assess severity of pruritus.
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At Month 12
|
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Patient-reported disease control after Atopic Dermatitis therapies in real life
時間枠:At Month 12
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Atopic Dermatitis Control Tool (ADCT) will be used to assess long term disease control.
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At Month 12
|
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Patient-reported quality of life after Atopic Dermatitis therapies in real life
時間枠:At Month 12
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Dermatology Life Quality Index (DLQI) will be used to assess quality of life, and DLQI for children (cDLQL) will be used for adolescence patients.
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At Month 12
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The Atopic Dermatitis related economic burden
時間枠:At Month 12
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Economic burden of Atopic Dermatitis will be evaluated using the cost of hospitalizations and outpatient visits associated with Atopic Dermatitis during the past one year.
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At Month 12
|
協力者と研究者
捜査官
- 主任研究者:Jianzhong Zhang、Peking University People's Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。