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PMS to Evaluate the Safety and Efficacy of Picato® Gel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02421471
Recruitment Status : Completed
First Posted : April 20, 2015
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief 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.


Condition or disease Intervention/treatment
Actinic Keratosis 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.

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Study Type : Observational
Actual Enrollment : 1324 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance to Evaluate the Safety and Efficacy of Picato® Gel
Actual Study Start Date : September 2014
Actual Primary Completion Date : January 19, 2018
Actual Study Completion Date : January 19, 2018

Resource links provided by the National Library of Medicine


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 Name: Picato®




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Children and adolescents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02421471


Locations
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Korea, Republic of
Department of Dermatology, Korea University Anam Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
LEO Pharma
Investigators
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Study Director: Sun Choi, B.Sc. LEO Pharma Limited, Korea
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02421471    
Other Study ID Numbers: NIS-PICATO-1130
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by LEO Pharma:
Actinic Keratosis
topical treatment
ingenol mebutate
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms