Actinic KeratosisPrAKticeNCT02594436
The Use of Picato® (Ingenol Mebutate) to Treat Actinic Keratosis in Standard Clinical Practice
An observational study of Actinic Keratosis, run by LEO Pharma at 1 site in Greece.
Trial summary
This is a prospective, non-interventional study of adult patients prescribed topical treatment with ingenol mebutate gel (Picato®) as part of provision of care for the treatment of Non-hyperkeratotic, non-hypertrophic Actinic Keratosis (AK). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Ingenol mebutate
- How many people
- 440 participants
- Where
- 1 siteGreece
- Study dates
- 1 Dec 2015to Nov 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients planned for starting treatment non-hyperkeratotic, non-hypertrophic actinic keratosis on face, scalp, trunk or extremities with topical ingenol mebutate gel.
Who may be able to join
- Planned to receive topical ingenol mebutate gel for treatment of Actinic Keratosis according to current labelling in Greece.
- Written informed consent obtained to use the patient's data for the study.
Who cannot join
- Contraindications according to prescribing information.
- Previous treatment with PICATO in the selected treatment area.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Picato® (Ingenol Mebutate) to Treat Actinic Keratosis in Standard Clinical Practice: A Prospective Phase IV, Multicentre, Pan-Hellenic Observational Cohort Study
This is a prospective, non-interventional study of adult patients prescribed topical treatment with ingenol mebutate gel (Picato®) as part of provision of care for the treatment of Non-hyperkeratotic, non-hypertrophic Actinic Keratosis (AK). Patients with complete clearance at 8 weeks will be followed for one year or until retreatment of AK in the area initially treated, whatever comes first. For patients with incomplete clearance in the treated area at 8 weeks the treatment strategy for this area will be recorded but no further follow-up will take place. The effectiveness, tolerability, adherence, patient satisfaction and health-related quality of life (HRQoL) associated with Picato® treatment will be evaluated.
Read the detailed description
Actinic Keratosis (AK) is caused by exposure to UV radiation and has the potential to regress to normal skin or to progress to squamous cell carcinoma. Ingenol mebutate gel is a relatively new topical treatment option for AK in Greece.
Taking into consideration the limited real-world evidence that is attributed to the recent advent of Picato in the Greek market, this non-interventional observational study aims primarily at assessing the characteristics of patients selected for this treatment, the effectiveness and tolerability of the treatment, patient satisfaction and the impact of the therapy on patients' HRQoL in standard clinical practice.The study will be carried out by approximately 30 physicians practicing in private or public hospitals and clinics in representative geographical regions of Greece.
- Conditions
- Actinic Keratosis
- Being tested
- Ingenol mebutate
- Keywords
- Actinic Keratosis, topical, ingenol mebutate, Picato®
- 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 mebutateDrug
Also called Picato
Non-Interventional study enrolling patients already planned to be treated with ingenol mebutate according to approved labelling
| Study group | Role | What they receive |
|---|---|---|
| Ingenol mebutate gel 0.015 percent | Topical treatment of face or scalp once daily for three consecutive days Receives: Drug: Ingenol mebutate | |
| Ingenol mebutate gel 0.05 percent | Topical treatment of trunk or extremities once daily for two consecutive days Receives: Drug: Ingenol mebutate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete clearance
Percentage of patients with no clinically visible remaining lesions in treated area
Measured: Around 8 weeks post treatment
Lesion count reduction
Reduction in number of clinically visible lesions in treated area compared to baseline count.
Measured: Around 8 weeks post treatment
Secondary outcomes (3)
Remission rate for patients with complete initial clearance
Proportion of patients without known recurrence of AK lesions in treated area for patients with complete initial clearance
Measured: 12 months
Patient satisfaction with treatment
Patient reported satisfaction with treatment as measured by the domains of effectiveness, convenience and global satisfaction of TSQM-9 (Treatment Satisfaction Questionnaire of Medication)
Measured: Around 8 weeks post treatment
Health Related Quality of Life EQ-5D-5L
EQ-5D-5L is a standardized instrument for use as a measure of health outcome. It provides a simple descriptive profile and a single index value for health status. EQ-5D-5L is designed for self-completion by respondents. It consists of two pages comprising the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: Baseline and around 8 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study start1 Dec 2015
- Primary completionNov 2017
- Study completionNov 2017
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
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kostas Sitaras, MD, Study director, LEO Pharma Hellas SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594436
- Sponsor's protocol ID
- NIS-PICATO-1220
- Acronym
- PrAKtice
- Status last verified
- Jan 2019
- First submitted
- 29 Oct 2015
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Picato® (Ingenol Mebutate) to Treat Actinic Keratosis in Standard Clinical Practice: A Prospective Phase IV, Multicentre, Pan-Hellenic Observational Cohort Study
- ClinicalTrials.gov ID
- NCT02594436
- Acronym / sponsor ID
- PrAKtice / NIS-PICATO-1220
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis, topical, ingenol mebutate, Picato®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 3 Nov 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 is a prospective, non-interventional study of adult patients prescribed topical treatment with ingenol mebutate gel (Picato®) as part of provision of care for the treatment of Non-hyperkeratotic, non-hypertrophic Actinic Keratosis (AK). Patients with complete clearance at 8 weeks will be followed for one year or until retreatment of AK in the area initially treated, whatever comes first. For patients with incomplete clearance in the treated area at 8 weeks the treatment strategy for this area will be recorded but no further follow-up will take place. The effectiveness, tolerability, adherence, patient satisfaction and health-related quality of life (HRQoL) associated with Picato® treatment will be evaluated.
Detailed description
Actinic Keratosis (AK) is caused by exposure to UV radiation and has the potential to regress to normal skin or to progress to squamous cell carcinoma. Ingenol mebutate gel is a relatively new topical treatment option for AK in Greece.
Taking into consideration the limited real-world evidence that is attributed to the recent advent of Picato in the Greek market, this non-interventional observational study aims primarily at assessing the characteristics of patients selected for this treatment, the effectiveness and tolerability of the treatment, patient satisfaction and the impact of the therapy on patients' HRQoL in standard clinical practice.The study will be carried out by approximately 30 physicians practicing in private or public hospitals and clinics in representative geographical regions of Greece.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ingenol mebutate gel 0.015 percent | – | Drug: Ingenol mebutateTopical treatment of face or scalp once daily for three consecutive days |
| Ingenol mebutate gel 0.05 percent | – | Drug: Ingenol mebutateTopical treatment of trunk or extremities once daily for two consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients planned for starting treatment non-hyperkeratotic, non-hypertrophic actinic keratosis on face, scalp, trunk or extremities with topical ingenol mebutate gel.
Key inclusion criteria (2 listed)
- Planned to receive topical ingenol mebutate gel for treatment of Actinic Keratosis according to current labelling in Greece.
- Written informed consent obtained to use the patient's data for the study.
Key exclusion criteria (2 listed)
- Contraindications according to prescribing information.
- Previous treatment with PICATO in the selected treatment area.
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 mebutateAlso: PicatoNon-Interventional study enrolling patients already planned to be treated with ingenol mebutate according to approved labelling | Drug | Ingenol mebutate gel 0.015 percent, Ingenol mebutate gel 0.05 percent |
Primary outcome
Rate of complete clearance
Time frame: Around 8 weeks post treatment
Percentage of patients with no clinically visible remaining lesions in treated area
Lesion count reduction
Time frame: Around 8 weeks post treatment
Reduction in number of clinically visible lesions in treated area compared to baseline count.
3 secondary outcomes
Remission rate for patients with complete initial clearance
Time frame: 12 months
Patient satisfaction with treatment
Time frame: Around 8 weeks post treatment
Health Related Quality of Life EQ-5D-5L
Time frame: Baseline and around 8 weeks post 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 22 Jan 2019.
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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.
Kostas Sitaras, MD study director
LEO Pharma Hellas SA
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 Greece.
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 2 inclusion and 2 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 22 Jan 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 Greece. 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?
Rate of complete clearance (time frame: Around 8 weeks post treatment). 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 22 Jan 2019.