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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Actinic Keratosis (AK)

Intervention / Treatment
-----------------
* Drug: Ingenol Mebutate Gel, 0.015%
* Drug: Diclofenac sodium gel 3%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Following verbal and written information about the trial, subject must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp Exclusion Criteria: 1. Location of the selected treatment area: on the periorbital skin on the perioral skin/around the nostrils within 5 cm of an incompletely healed wound within 10 cm of a suspected BCC or SCC or other neoplasia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment Group A<br>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. | Drug: Ingenol Mebutate Gel, 0.015%<br>* Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.<br>* Other names: Picato®;|
| Active Comparator: Treatment Group B<br>Diclofenac sodium gel 3%, (0.5 grams), twice daily for 90 days. | Drug: Diclofenac sodium gel 3%<br>* Diclofenac sodium gel 3% Solaraze® applied on the selected treatment area, twice daily for 90 days.<br>* Other names: Solaraze®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete clearance of all AKs | Complete clearance of all AKs in the treatment field at Week 8 for ingenol mebutate gel 0.015% and Week 17 for diclofenac sodium gel 3% | 11 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete clearance of all AKs at Week 17 | As secondary response criteria, complete clearance at Week 17 for diclofenac sodium gel 3% will be compared with complete clearance in the ingenol mebutate 0.015% group. | 11 Months |