Clinical trial NCT02594436: The Use of Picato® (Ingenol Mebutate) to Treat Actinic Keratosis in Standard Clinical Practice
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
topical
ingenol mebutate
Picato®
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2015-11-03
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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). 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of complete clearance
timeFrame: Around 8 weeks post treatment
measure: Lesion count reduction
timeFrame: Around 8 weeks post treatment
Secondary outcomes:
measure: Remission rate for patients with complete initial clearance
timeFrame: 12 months
measure: Patient satisfaction with treatment
timeFrame: Around 8 weeks post treatment
measure: Health Related Quality of Life EQ-5D-5L
timeFrame: Baseline and around 8 weeks post treatment
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Office Based Physician
state: Peristeri
Study officials:
affiliation: LEO Pharma Hellas SA
name: Kostas Sitaras, MD
role: STUDY_DIRECTOR
References: