PMS to Evaluate the Safety and Efficacy of Picato® Gel
Post-Marketing Surveillance to Evaluate the Safety and Efficacy of Picato® Gel
1 other identifier
observational
1,324
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 15, 2015
CompletedFirst Posted
Study publicly available on registry
April 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2018
CompletedDecember 13, 2019
January 1, 2018
3.4 years
April 15, 2015
December 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adverse Events
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
8 weeks after treatment completion
Overall improvement
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
Secondary Outcomes (3)
Complete clearance rate - Change in AK lesions count: Percentage (%) change in the total number of AK lesions compared to baseline*
8 weeks after treatment
Partial clearance rate
8 weeks after treatment
Change in AK lesion count
8 weeks after treatment
Study Arms (1)
Ingenol mebutate treatment cohort
Patients who are prescribed ingenol mebutate gel for the first time by investigator's medical judgment.
Interventions
Topical treatment with ingenol mebutate gel 0.015 percent or 0.05 percent gel of skin areas affected by AK
Eligibility Criteria
Consecutive adult patients with AK in involved PMS sites treated for the first time with ingenol mebutate 0.015 or 0.05 percent gel.
You may qualify if:
- Adult patient with AK First time treatment with ingenol mebutate 0.015 or 0.05 percent gel
You may not qualify if:
- Children and adolescents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LEO Pharmalead
Study Sites (1)
Department of Dermatology, Korea University Anam Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sun Choi, B.Sc.
LEO Pharma Limited, Korea
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2015
First Posted
April 20, 2015
Study Start
September 1, 2014
Primary Completion
January 19, 2018
Study Completion
January 19, 2018
Last Updated
December 13, 2019
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share