drugset / Trial / NCT02547233
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days as field treatment.
Timeline
- Start
- 2015-11
- Primary completion
- 2016-11
- Completion
- 2017-11
Outcome
Met primary endpoint
registry analysis (superiority test); LEO 43204 0.018% Gel vs Vehicle Gel; p <0.001; Ratio of clearance rates 30.55 (95% CI 4.28 to 218.0); Mantel Haenszel NCT02547233 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ingenol disoxate | Small molecule | — | Topical |