Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

Summary

This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2 trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily treatment for 2, 3 or 4 consecutive days compared to vehicle gel

Timeline

Start

2014-01

Primary completion

2014-07

Completion

2014-07

Outcome

Missed primary endpoint

registry analysis (superiority test); Ingenol 3 Days vs Vehicle; p = 0.18 NCT01998984 ↗

registry analysis (superiority test); Ingenol 2 Days vs Vehicle; p = 0.051 NCT01998984 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ingenol mebutate	Small molecule	0.06 %	Topical

Indications