Actinic Keratosis Clinical Trial
Official title:
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.
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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