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PMS to Evaluate the Safety and Efficacy of Picato® Gel

NCT ID: NCT02421471

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1324 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-01-19

Brief Summary

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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

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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

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Actinic Keratosis

Keywords

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Actinic Keratosis topical treatment ingenol mebutate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ingenol mebutate treatment cohort

Patients 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

Intervention Type DRUG

Topical treatment with ingenol mebutate gel 0.015 percent or 0.05 percent gel of skin areas affected by AK

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Picato®

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Children and adolescents
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LEO Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sun Choi, B.Sc.

Role: STUDY_DIRECTOR

LEO Pharma Limited, Korea

Locations

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Department of Dermatology, Korea University Anam Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NIS-PICATO-1130

Identifier Type: -

Identifier Source: org_study_id