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

NCT ID: NCT02594436

Last Updated: 2019-01-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 440 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-12-01
• Study Completion Date: 2017-11-30

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.

Conditions

Actinic Keratosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Ingenol mebutate gel 0.015 percent

Topical treatment of face or scalp once daily for three consecutive days

Ingenol mebutate

Intervention Type: DRUG

Non-Interventional study enrolling patients already planned to be treated with ingenol mebutate according to approved labelling

Ingenol mebutate gel 0.05 percent

Topical treatment of trunk or extremities once daily for two consecutive days

Ingenol mebutate

Intervention Type: DRUG

Non-Interventional study enrolling patients already planned to be treated with ingenol mebutate according to approved labelling

Interventions

Ingenol mebutate

Non-Interventional study enrolling patients already planned to be treated with ingenol mebutate according to approved labelling

Intervention Type: DRUG

Other Intervention Names

Picato

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kostas Sitaras, MD

Role: STUDY_DIRECTOR

LEO Pharma Hellas SA

Locations

Office Based Physician

Athens, Peristeri, Greece

Countries

Greece

Other Identifiers

NIS-PICATO-1220

Identifier Type: -

Identifier Source: org_study_id