Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or Scalp

Overview

This is a phase 4, multi-centre, randomized, two group, open label, active controlled, parallel group, 17 week trial.

All subjects who qualify for this trial are to have 4 to 8 clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the face or scalp. Eligible subjects will be randomised in a 1:1 ratio to the following treatment groups: * Treatment Group A: Ingenol mebutate gel 0.015%, once daily for 3 consecutive days for the first treatment course. At 8 weeks after treatment initiation, subjects who present with existing AKs or newly emergent AKs in the treatment area will receive one more treatment course of ingenol mebutate gel 0.015%, daily for 3 consecutive days. * Treatment Group B: Diclofenac sodium gel 3%, (0.5 grams), twice daily for 90 days.

Conditions

Interventions

Eligibility

Locations (1)

Outcomes