The Use of Picato® (Ingenol Mebutate) to Treat Actinic Keratosis in Standard Clinical Practice

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Use of Picato® (Ingenol Mebutate) to Treat Actinic Keratosis in Standard Clinical Practice: A Prospective Phase IV, Multicentre, Pan-Hellenic Observational Cohort Study

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: Ingenol mebutate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Contraindications according to prescribing information. Previous treatment with PICATO in the selected treatment area.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ingenol mebutate gel 0.015 percent<br>Topical treatment of face or scalp once daily for three consecutive days | Drug: Ingenol mebutate<br>* Non-Interventional study enrolling patients already planned to be treated with ingenol mebutate according to approved labelling<br>* Other names: Picato;|
| Ingenol mebutate gel 0.05 percent<br>Topical treatment of trunk or extremities once daily for two consecutive days | Drug: Ingenol mebutate<br>* Non-Interventional study enrolling patients already planned to be treated with ingenol mebutate according to approved labelling<br>* Other names: Picato;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complete clearance | Percentage of patients with no clinically visible remaining lesions in treated area | Around 8 weeks post treatment | 
| Lesion count reduction | Reduction in number of clinically visible lesions in treated area compared to baseline count. | Around 8 weeks post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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. | Baseline and around 8 weeks post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Actinic Keratosis, topical, ingenol mebutate, Picato®