Actinic KeratosisNCT02421471
PMS to Evaluate the Safety and Efficacy of Picato® Gel
An observational study of Actinic Keratosis, run by LEO Pharma at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Ingenol mebutate 0.015 percent or 0.05 percent gel
- How many people
- 1,324 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2014to 19 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patient with AK First time treatment with ingenol mebutate 0.015 or 0.05 percent gel
Who cannot join
- Children and adolescents
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Dermatology, Korea University Anam Hospital
Seoul
About this study
Official title: Post-Marketing Surveillance 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.
Read the 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.
- Conditions
- Actinic Keratosis
- Being tested
- Ingenol mebutate 0.015 percent or 0.05 percent gel
- Keywords
- Actinic Keratosis, topical treatment, ingenol mebutate
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingenol mebutate 0.015 percent or 0.05 percent gelDrug
Also called Picato®
Topical treatment with ingenol mebutate gel 0.015 percent or 0.05 percent gel of skin areas affected by AK
| Study group | Role | What they receive |
|---|---|---|
| Ingenol mebutate treatment cohort | Patients who are prescribed ingenol mebutate gel for the first time by investigator's medical judgment. Receives: Drug: Ingenol mebutate 0.015 percent or 0.05 percent gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks after treatment completion
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
Measured: 8 weeks after treatment completion
Secondary outcomes (3)
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
Measured: 8 weeks after treatment
Partial clearance rate
Proportion of patients with 75% or greater reduction in the number of AK lesions in treated area compared to baseline
Measured: 8 weeks after treatment
Change in AK lesion count
Percentage change in the total number of AK lesions in treated area compared to baseline
Measured: 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startSep 2014
- Primary completion19 Jan 2018
- Study completion19 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,324 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sun Choi, B.Sc., Study director, LEO Pharma Limited, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421471
- Sponsor's protocol ID
- NIS-PICATO-1130
- Status last verified
- Jan 2018
- First submitted
- 15 Apr 2015
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance to Evaluate the Safety and Efficacy of Picato® Gel
- ClinicalTrials.gov ID
- NCT02421471
- Acronym / sponsor ID
- NIS-PICATO-1130
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis, topical treatment, ingenol mebutate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,324 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2014 (actual)
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- 19 Jan 2018 (actual)
- First posted
- 20 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ingenol mebutate treatment cohort | – | Drug: 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult patient with AK First time treatment with ingenol mebutate 0.015 or 0.05 percent gel
Key exclusion criteria (1 listed)
- Children and adolescents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ingenol mebutate 0.015 percent or 0.05 percent gelAlso: Picato®Topical treatment with ingenol mebutate gel 0.015 percent or 0.05 percent gel of skin areas affected by AK | Drug | Ingenol mebutate treatment cohort |
Primary outcome
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
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
3 secondary outcomes
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
Partial clearance rate
Time frame: 8 weeks after treatment
Change in AK lesion count
Time frame: 8 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun Choi, B.Sc. study director
LEO Pharma Limited, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Actinic Keratosis, run by LEO Pharma at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 8 weeks after treatment completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.