drugset / Trial / NCT02361216

Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest

NCT02361216 ↗

Phase 3 Completed 729 enrolled LEO Pharma
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objective of the trial is to investigate efficacy and safety of ingenol mebutate gel for actinic keratosis applied to large treatment areas once daily for three consecutive days on face, scalp or chest.

Timeline

Start
2015-04
Primary completion
2016-03
Completion
2017-03

Outcome

Met primary endpoint

registry NUMBER Ingenol Mebutate Gel: 21.4 percentage of participants NUMBER Vehicle: 3.4 percentage of participants analysis (unspecified test); Ingenol Mebutate Gel vs Vehicle; p <0.001 NCT02361216 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject ingenol mebutate Small molecule — Topical

Indications