Clinical trial · Observational
PMS to Evaluate the Safety and Efficacy of Picato® Gel
Post-Marketing Surveillance to Evaluate the Safety and Efficacy of Picato® Gel
NCT02421471CI-TRIAL-00042235completedClinicalTrials.gov clinicaltrialsProvenance
- 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 study is a mandatory post launch observational study in South Korea of 3.000 patients receiving treatment for the first time with a new medicinal product, ingenol mebutate gel (Picato®), approved for topical treatment of actinic keratosis. Each patient is observed for 8 weeks after treatment completion.
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 0.015 percent or 0.05 percent gel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ingenol mebutate treatment cohort
- description
- Patients who are prescribed ingenol mebutate gel for the first time by investigator's medical judgment.
- interventionNames
- Drug: Ingenol mebutate 0.015 percent or 0.05 percent gel
Primary outcomes (2)
- measure
- Adverse Events
- timeFrame
- 8 weeks after treatment completion
- description
- According to Korean definition and classification, covering serious as well as non-serious Adverse Events, related as well as non-related to ingenol mebutate treatment
- measure
- Overall improvement
- timeFrame
- 8 weeks after treatment completion
- description
- Graded by investigator on a 3-point scale ('improved', 'no change', 'worsened'), based on number of AK lesions in treated area compared to baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: Adult patient with AK First time treatment with ingenol mebutate 0.015 or 0.05 percent gel Exclusion Criteria: * Children and adolescents
References
Publications (0)
Data not yet available
No reference posted for this study.