drugset / Trial / NCT02549339
Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest including12-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
- 2015-11-13
- Primary completion
- 2016-08-05
- Completion
- 2017-08-10
Outcome
Met primary endpoint
registry analysis (superiority test); LEO 43204 0.018% Gel vs Vehicle Gel; p = 0.001; Ratio of clearance rates 7.57 (95% CI 2.26 to 25.31); Mantel Haenszel NCT02549339 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ingenol disoxate | Small molecule | — | Topical |