NCT02424305

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	LEO 43204 gel 0.018%
DRUG	LEO 43204 gel 0.1%
DRUG	LEO 43204 gel 0.037%

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-04-23
• Last updated: 2025-02-24

Locations

1 site across 1 country: United States