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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ingenol mebutate gel 0.015 percent | Topical treatment of face or scalp once daily for three consecutive days |
| |
| Ingenol mebutate gel 0.05 percent | Topical treatment of trunk or extremities once daily for two consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ingenol mebutate | Drug | Non-Interventional study enrolling patients already planned to be treated with ingenol mebutate according to approved labelling |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients planned for starting treatment non-hyperkeratotic, non-hypertrophic actinic keratosis on face, scalp, trunk or extremities with topical ingenol mebutate gel.
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| Name | Affiliation | Role |
|---|---|---|
| Kostas Sitaras, MD | LEO Pharma Hellas SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Office Based Physician | Athens | Peristeri | 12134 | Greece |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C486592 | 3-ingenyl angelate |
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|
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 |
| D017437 |
| Skin and Connective Tissue Diseases |