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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ingenol mebutate treatment cohort | Patients who are prescribed ingenol mebutate gel for the first time by investigator's medical judgment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ingenol mebutate 0.015 percent or 0.05 percent gel | Drug | Topical treatment with ingenol mebutate gel 0.015 percent or 0.05 percent gel of skin areas affected by AK |
|
| 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 |
| 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 |
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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:
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Consecutive adult patients with AK in involved PMS sites treated for the first time with ingenol mebutate 0.015 or 0.05 percent gel.
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| Name | Affiliation | Role |
|---|---|---|
| Sun Choi, B.Sc. | LEO Pharma Limited, Korea | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Korea University Anam Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C486592 | 3-ingenyl angelate |
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|
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 |
| D017437 |
| Skin and Connective Tissue Diseases |