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

Completed · Phase 2 · Has a placebo group

Conditions studied: Actinic Keratosis

In brief

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

Key facts

Study ID

NCT01998984

Run by

LEO Pharma

People needed

266

Starts

2014-01-01

Expected to finish

2014-07-01

Last updated by the study team

2025-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Long Island Skin Cancer and Dermatologic Surgery — Smithtown, New York, United States

Full record on ClinicalTrials.gov

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