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

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

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

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.

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.

Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of 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%

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.

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

Stockfleth E, Harwood CA, Serra-Guillen C, Larsson T, Osterdal ML, Skov T. Phase IV head-to-head randomized controlled trial comparing ingenol mebutate 0.015% gel with diclofenac sodium 3% gel for the treatment of actinic keratosis on the face or scalp. Br J Dermatol. 2018 Feb;178(2):433-442. doi: 10.1111/bjd.16048. Epub 2018 Jan 15.