Actinic Keratosis
Conditions
Keywords
Actinic Keratosis, topical, ingenol mebutate, Picato®
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.
Interventions
DRUGIngenol mebutate
Non-Interventional study enrolling patients already planned to be treated with ingenol mebutate according to approved labelling
Sponsors
LEO Pharma
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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. |
Countries
Greece
Outcome results
None listed