PMS to Evaluate the Safety and Efficacy of Picato® Gel

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Post-Marketing Surveillance to Evaluate the Safety and Efficacy of Picato® Gel

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: Ingenol mebutate 0.015 percent or 0.05 percent gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient with AK First time treatment with ingenol mebutate 0.015 or 0.05 percent gel Exclusion Criteria: Children and adolescents

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ingenol mebutate treatment cohort<br>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<br>* Topical treatment with ingenol mebutate gel 0.015 percent or 0.05 percent gel of skin areas affected by AK<br>* Other names: Picato®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete clearance rate - Change in AK lesions count: Percentage (%) change in the total number of AK lesions compared to baseline* | Proportion of patients with no clinically visible AK lesions in treated area | 8 weeks after treatment | 
| Partial clearance rate | Proportion of patients with 75% or greater reduction in the number of AK lesions in treated area compared to baseline | 8 weeks after treatment | 
| Change in AK lesion count | Percentage change in the total number of AK lesions in treated area compared to baseline | 8 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Actinic Keratosis, topical treatment, ingenol mebutate