NCT02421471

PMS to Evaluate the Safety and Efficacy of Picato® Gel

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,324 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-01-19
• Completion: 2018-01-19
• First posted: 2015-04-20
• Last updated: 2019-12-13

Locations

1 site across 1 country: South Korea