PMS to Evaluate the Safety and Efficacy of Picato® Gel

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.

Study Overview

• Status: Completed
• Conditions: Actinic Keratosis
• Intervention / Treatment: Drug: Ingenol mebutate 0.015 percent or 0.05 percent gel

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.

• Study Type: Observational
• Enrollment (Actual): 1324

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Department of Dermatology, Korea University Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients with AK in involved PMS sites treated for the first time with ingenol mebutate 0.015 or 0.05 percent gel.

Description

Inclusion Criteria:

Adult patient with AK First time treatment with ingenol mebutate 0.015 or 0.05 percent gel

Exclusion Criteria:

• Children and adolescents

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: Picato®

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Study Director: Sun Choi, B.Sc., LEO Pharma Limited, Korea

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): January 19, 2018
• Study Completion (Actual): January 19, 2018

Study Registration Dates

• First Submitted: April 15, 2015
• First Submitted That Met QC Criteria: April 17, 2015
• First Posted (Estimate): April 20, 2015

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Actinic Keratosis; topical treatment; ingenol mebutate
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: NIS-PICATO-1130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No