Pharmacokinetics of LEO 43204 Gel in Actinic Keratosis Administered Under Maximal Use Conditions

NCT02424305 Phase 1 COMPLETED

This is an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel groups will be enrolled. The trial includes three active treatment groups. To be eligible for inclusion in this trial, subjects must have at least 15 clinically typical, visible, and discrete actinic keratosis (AKs) on the face, scalp or on the arm within a contiguous area of approximately 250 cm2 of sun-damaged skin. There will be 3 treatment groups: (1) once daily application of LEO43204 gel 0.018% on the full face for three consecutive days, (2) once daily application of LEO43204 gel 0.1% on the arm on a treatment area of approximately 250 cm2 for three consecutive days and , (3) once daily application of LEO43204 gel 0.037 % on the scalp for three consecutive days.

Details

Lead sponsor	LEO Pharma
Phase	Phase 1
Status	COMPLETED
Enrolment	60
Start date	2015-05
Completion	2015-07

Conditions

• Actinic Keratosis

Interventions

• LEO 43204 gel 0.018%
• LEO 43204 gel 0.1%
• LEO 43204 gel 0.037%

Primary outcomes

• Area under the plasma concentration versus time curve (AUC) of LEO 43204. — Once daily for 3 days
• Peak Plasma Concentration (Cmax) of LEO 43204. — Once daily for 3 days

Countries

United States