Who is sponsoring NCT02361216?

NCT02361216 is sponsored by LEO Pharma.

What condition does NCT02361216 study?

NCT02361216 studies Actinic Keratosis.

What drugs are being tested in NCT02361216?

Interventions: Ingenol Mebutate, Vehicle.

What is the status of NCT02361216?

NCT02361216 is currently COMPLETED.

Last reviewed 2025-02-21 · How we verify

Efficacy and Safety of Ingenol Mebutate Gel in Field Treatment of Actinic Keratosis on Full Face, Balding Scalp or Approximately 250 cm2 on the Chest

NCT02361216 Phase 3 COMPLETED Results posted

The objective of the trial is to investigate efficacy and safety of ingenol mebutate gel for actinic keratosis applied to large treatment areas once daily for three consecutive days on face, scalp or chest.

Details

Lead sponsor	LEO Pharma
Phase	Phase 3
Status	COMPLETED
Enrolment	729
Start date	2015-04
Completion	2017-03

Conditions

Actinic Keratosis

Interventions

Ingenol Mebutate
Vehicle

Primary outcomes

Percentage of Participants With Complete Resolution of Actinic Keratosis (AK) — 8 weeks
Complete resolution of actinic keratosis (AKclear100) at Week 8 is defined as 100% reduction from baseline in the number of clinically visible AKs

Countries

United States