PMS to Evaluate the Safety and Efficacy of Picato® Gel

NCT02421471 — Completed, 1324 participants, LEO Pharma
ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT02421471
StatusCompleted
Study typeObservational
Enrollment1324 (Actual)
SponsorLEO Pharma (Industry)
ConditionsActinic Keratosis
InterventionsIngenol mebutate 0.015 percent or 0.05 percent gel (Drug)
Datesstart 2014-09-01, primary completion 2018-01-19, completion 2018-01-19, first posted 2015-04-20, last updated 2019-12-13
Locations1 site in South Korea

Related Papers Related Patents Related Grants Related Experts
All trials for Actinic Keratosis All trials of Ingenol mebutate 0.015 percent or 0.05 percent gel

-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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
Ingenol mebutate treatment cohortDrug: Ingenol mebutate 0.015 percent or 0.05 percent gelPatients who are prescribed ingenol mebutate gel for the first time by investigator's medical judgment.
  • Ingenol mebutate 0.015 percent or 0.05 percent gel (Drug), also known as Picato®: Topical treatment with ingenol mebutate gel 0.015 percent or 0.05 percent gel of skin areas affected by AK

+Outcome measures

Primary outcomes

  • Adverse Events [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
  • Overall improvement [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

  • Complete clearance rate - Change in AK lesions count: Percentage (%) change in the total number of AK lesions compared to baseline* [8 weeks after treatment]: Proportion of patients with no clinically visible AK lesions in treated area
  • Partial clearance rate [8 weeks after treatment]: Proportion of patients with 75% or greater reduction in the number of AK lesions in treated area compared to baseline
  • Change in AK lesion count [8 weeks after treatment]: Percentage change in the total number of AK lesions in treated area compared to baseline

+Eligibility

Sex: All, ages: 19 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

* Children and adolescents

+Locations (1)

FacilityCityCountryStatus
Department of Dermatology, Korea University Anam HospitalSeoulSouth Korea

+Investigators