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

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.

Study Overview

• Status: Completed
• Conditions: Actinic Keratosis
• Intervention / Treatment: Drug: Ingenol mebutate

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 Type: Observational
• Enrollment (Actual): 440

Contacts and Locations

Study Locations

• Greece
  • Peristeri
    • Athens, Peristeri, Greece, 12134
      • Office Based Physician

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Study Director: Kostas Sitaras, MD, LEO Pharma Hellas SA

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: October 29, 2015
• First Submitted That Met QC Criteria: October 30, 2015
• First Posted (Estimate): November 3, 2015

Study Record Updates

• Last Update Posted (Actual): January 22, 2019
• Last Update Submitted That Met QC Criteria: January 18, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Actinic Keratosis; ingenol mebutate; topical; Picato®
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: NIS-PICATO-1220