drugset / Trial / NCT02547233

Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up

NCT02547233 ↗

Phase 3 Completed 437 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
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

EvaluationDrugModalityDoseRoute
Subject Ingenol disoxate Small molecule — Topical

Indications