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Completed

NCT Number: NCT02421471

PMS 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.

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Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Dermatology, Korea University Anam Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Children and adolescents

Treatment and study plan

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

Other names: Picato®

Primary outcomes

  1. Adverse Events

    Time frame: 8 weeks after treatment completion

    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

  2. Overall improvement

    Time frame: 8 weeks after treatment completion

    Graded by investigator on a 3-point scale ('improved', 'no change', 'worsened'), based on number of AK lesions in treated area compared to baseline

Secondary outcomes

  1. Complete clearance rate - Change in AK lesions count: Percentage (%) change in the total number of AK lesions compared to baseline*

    Time frame: 8 weeks after treatment

    Proportion of patients with no clinically visible AK lesions in treated area

  2. Partial clearance rate

    Time frame: 8 weeks after treatment

    Proportion of patients with 75% or greater reduction in the number of AK lesions in treated area compared to baseline

  3. Change in AK lesion count

    Time frame: 8 weeks after treatment

    Percentage change in the total number of AK lesions in treated area compared to baseline

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 20, 2015
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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