PMS to Evaluate the Safety and Efficacy of Picato® Gel

Actinic Keratosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02421471
• Other study ID #: NIS-PICATO-1130
• Status: Completed
• Start date: September 2014
• Est. completion date: January 19, 2018

Study information

• Verified date: January 2018
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1324
• Est. completion date: January 19, 2018
• Est. primary completion date: January 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Children and adolescents

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Dermatology, Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Change in AK lesion count	Percentage change in the total number of AK lesions in treated area compared to baseline	8 weeks after treatment