Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Part 1: To identify Maximum Tolerated Dose (MTD) levels of LEO 43204 after once daily treatment for two consecutive days

Part 2: To evaluate the efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LEO Pharma

Criteria

Inclusion Criteria:

• Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the arm

• Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the extremities or trunk

Exclusion Criteria:

• Location of the treatment area

• 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 gel on the treatment area

• Lesions in the treatment areas 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)