PMS to Evaluate the Safety and Efficacy of Picato® Gel
Post-Marketing Surveillance to Evaluate the Safety and Efficacy of Picato® Gel
This study is a mandatory post launch observational study in South Korea of 3.000 patients receiving treatment for the first time with a new medicinal product, ingenol mebutate gel (Picato®), approved for topical treatment of actinic keratosis.
Each patient is observed for 8 weeks after treatment completion.
調査の概要
詳細な説明
Picato® (ingenol mebutate) gel is a new topical therapy for Actinic Keratosis (AK) in adults which was approved by the Korean Ministry of Food and Drug Safety (MFDS) in December 2013. For AK in face or scalp the 0.015 percent gel is approved to be applied once a day for 3 consecutive days, and for AK in trunk or extremities the 0.05 percent gel is approved to be applied once a day for 2 consecutive days.
The re-examination period for Picato® runs from December 2013 to December 2019, during which at least 3,000 patients who are prescribed ingenol mebutate gel for the first time by investigator's medical judgment must be documented in a standard Post Marketing Surveillance (PMS) study.
Each patient is to be observed for 8 weeks following application of ingenol mebutate gel. If a patient is unable to visit the PMS site, the investigator may contact the patient by phone to assess the safety.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
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Seoul、大韓民国
- Department of Dermatology, Korea University Anam Hospital
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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:
Adult patient with AK First time treatment with ingenol mebutate 0.015 or 0.05 percent gel
Exclusion Criteria:
- Children and adolescents
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
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Ingenol mebutate treatment cohort
Patients who are prescribed ingenol mebutate gel for the first time by investigator's medical judgment.
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Topical treatment with ingenol mebutate gel 0.015 percent or 0.05 percent gel of skin areas affected by AK
他の名前：
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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 |
|---|---|---|
|
Adverse Events
時間枠：8 weeks after treatment completion
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According to Korean definition and classification, covering serious as well as non-serious Adverse Events, related as well as non-related to ingenol mebutate treatment
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8 weeks after treatment completion
|
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Overall improvement
時間枠：8 weeks after treatment completion
|
Graded by investigator on a 3-point scale ('improved', 'no change', 'worsened'), based on number of AK lesions in treated area compared to baseline
|
8 weeks after treatment completion
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Complete clearance rate - Change in AK lesions count: Percentage (%) change in the total number of AK lesions compared to baseline*
時間枠：8 weeks after treatment
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Proportion of patients with no clinically visible AK lesions in treated area
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8 weeks after treatment
|
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Partial clearance rate
時間枠：8 weeks after treatment
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Proportion of patients with 75% or greater reduction in the number of AK lesions in treated area compared to baseline
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8 weeks after treatment
|
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Change in AK lesion count
時間枠：8 weeks after treatment
|
Percentage change in the total number of AK lesions in treated area compared to baseline
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8 weeks after treatment
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Sun Choi, B.Sc.、LEO Pharma Limited, Korea
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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。