drugset / Trial / NCT02549339

Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest including12-month Follow-up

NCT02549339 ↗

Phase 3 Completed 383 enrolled LEO Pharma
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

EvaluationDrugModalityDoseRoute
Subject Ingenol disoxate Small molecule — Topical

Indications