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