Clinical trial · Observational
The Use of Picato® (Ingenol Mebutate) to Treat Actinic Keratosis in Standard Clinical Practice
The Use of Picato® (Ingenol Mebutate) to Treat Actinic Keratosis in Standard Clinical Practice: A Prospective Phase IV, Multicentre, Pan-Hellenic Observational Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ingenol mebutate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Ingenol mebutate gel 0.015 percent
- description
- Topical treatment of face or scalp once daily for three consecutive days
- interventionNames
- Drug: Ingenol mebutate
- label
- Ingenol mebutate gel 0.05 percent
- description
- Topical treatment of trunk or extremities once daily for two consecutive days
- interventionNames
- Drug: Ingenol mebutate
Primary outcomes (2)
- measure
- Rate of complete clearance
- timeFrame
- Around 8 weeks post treatment
- description
- Percentage of patients with no clinically visible remaining lesions in treated area
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available