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

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

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

Inclusion Criteria:

Subjects with 5 to 20 clinically typical, visible and discrete AKs within a contiguous area of approximately 250 cm² sun-damaged skin on either trunk (except chest), or extremities

Exclusion Criteria:

• Location of the treatment area (trunk (except chest) or extremities)

  • within 5 cm of an incompletely healed wound,
  • within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)

• Prior treatment with ingenol mebutate within the selected treatment area

• Lesions in the treatment area that have:

  • atypical clinical appearance (e.g., hypertrophic,hyperkeratotic or cutaneous horns) and/or,
  • recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions)