The Use of Picato® (Ingenol Mebutate) to Treat Actinic Keratosis in Standard Clinical Practice
- Registration Number
- NCT02594436
- Lead Sponsor
- LEO Pharma
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 440
- 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.
- Contraindications according to prescribing information.
- Previous treatment with PICATO in the selected treatment area.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ingenol mebutate gel 0.05 percent Ingenol mebutate Topical treatment of trunk or extremities once daily for two consecutive days Ingenol mebutate gel 0.015 percent Ingenol mebutate Topical treatment of face or scalp once daily for three consecutive days
- Primary Outcome Measures
Name Time Method Rate of complete clearance Around 8 weeks post treatment Percentage of patients with no clinically visible remaining lesions in treated area
Lesion count reduction Around 8 weeks post treatment Reduction in number of clinically visible lesions in treated area compared to baseline count.
- Secondary Outcome Measures
Name Time Method Remission rate for patients with complete initial clearance 12 months Proportion of patients without known recurrence of AK lesions in treated area for patients with complete initial clearance
Health Related Quality of Life EQ-5D-5L Baseline and around 8 weeks post treatment 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.
Patient satisfaction with treatment Around 8 weeks post 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)
Trial Locations
- Locations (1)
Office Based Physician
🇬🇷Athens, Peristeri, Greece