PMS to Evaluate the Safety and Efficacy of Picato® Gel
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|ClinicalTrials.gov Identifier: NCT02421471|
Recruitment Status : Completed
First Posted : April 20, 2015
Last Update Posted : December 13, 2019
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.
|Condition or disease||Intervention/treatment|
|Actinic Keratosis||Drug: Ingenol mebutate 0.015 percent or 0.05 percent gel|
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.
|Study Type :||Observational|
|Actual Enrollment :||1324 participants|
|Official Title:||Post-Marketing Surveillance to Evaluate the Safety and Efficacy of Picato® Gel|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||January 19, 2018|
|Actual Study Completion Date :||January 19, 2018|
Ingenol mebutate treatment cohort
Patients who are prescribed ingenol mebutate gel for the first time by investigator's medical judgment.
Drug: Ingenol mebutate 0.015 percent or 0.05 percent gel
Topical treatment with ingenol mebutate gel 0.015 percent or 0.05 percent gel of skin areas affected by AK
Other Name: Picato®
- Adverse Events [ Time Frame: 8 weeks after treatment completion ]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
- Overall improvement [ Time Frame: 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
- Complete clearance rate - Change in AK lesions count: Percentage (%) change in the total number of AK lesions compared to baseline* [ Time Frame: 8 weeks after treatment ]Proportion of patients with no clinically visible AK lesions in treated area
- Partial clearance rate [ Time Frame: 8 weeks after treatment ]Proportion of patients with 75% or greater reduction in the number of AK lesions in treated area compared to baseline
- Change in AK lesion count [ Time Frame: 8 weeks after treatment ]Percentage change in the total number of AK lesions in treated area compared to baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02421471
|Korea, Republic of|
|Department of Dermatology, Korea University Anam Hospital|
|Seoul, Korea, Republic of|
|Study Director:||Sun Choi, B.Sc.||LEO Pharma Limited, Korea|