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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Seoul, 대한민국
- Department of Dermatology, Korea University Anam Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
Adult patient with AK First time treatment with ingenol mebutate 0.015 or 0.05 percent gel
Exclusion Criteria:
- Children and adolescents
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Adverse Events
기간: 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
기간: 8 weeks after treatment completion
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Graded by investigator on a 3-point scale ('improved', 'no change', 'worsened'), based on number of AK lesions in treated area compared to baseline
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8 weeks after treatment completion
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Complete clearance rate - Change in AK lesions count: Percentage (%) change in the total number of AK lesions compared to baseline*
기간: 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
기간: 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
기간: 8 weeks after treatment
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Percentage change in the total number of AK lesions in treated area compared to baseline
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8 weeks after treatment
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Sun Choi, B.Sc., LEO Pharma Limited, Korea
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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광선 각화증에 대한 임상 시험
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Chulalongkorn UniversityHealth Systems Research Institute,Thailand모병