Clinical trial · Interventional
Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis
NCT02120456CI-TRIAL-00086824completedPhase 1 / Phase 2Results postedClinicalTrials.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)
Part 1: To identify Maximum Tolerated Dose (MTD) levels of LEO 43204 after once daily treatment for two consecutive days Part 2: To evaluate the efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LEO 43204 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- LEO 43204
- description
- Open-label, dose-escalation, 2-day treatment
- interventionNames
- Drug: LEO 43204
- type
- EXPERIMENTAL
- label
- LEO 43204 Dose 0.1%
- description
- LEO 43204 dose 0.1% once daily for two consecutive days
- interventionNames
- Drug: LEO 43204
- type
- EXPERIMENTAL
- label
- LEO 43204 Dose 0.075%
- description
- LEO 43204 dose 0.075% once daily for two days
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the arm * Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the extremities or trunk Exclusion Criteria: * Location of the treatment area * within 5 cm of an incompletely healed wound * within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) * Prior treatment with ingenol mebutate gel on the treatment area * Lesions in the treatment areas that have: * atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or * recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions)
References
Publications (0)
Data not yet available
No reference posted for this study.