NCT02124239

Pharmacokinetics of Ingenol Mebutate Gel in Actinic Keratosis Under Maximum Use Conditions

A Phase I, Multi-centre, Open-label, Uncontrolled, Non-randomised Study to Evaluate the Systemic Exposure and Safety of Ingenol Mebutate When Applied to Full Face, Balding Scalp or an Area of Approximately 250 cm2 on the Arm in Subjects With Actinic Keratosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 79 (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 10 clinically typical, visible, and discrete AKs on the face, balding 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 ingenol mebutate gel 0.027% on the full face for three consecutive days, (2) the same regimen on the balding scalp, and (3) once daily application of ingenol mebutate gel 0.06% on the arm on a treatment area of approximately 250 cm2 for four consecutive days.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Ingenol mebutate

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2014-04-28
• Last updated: 2025-02-24

Locations

1 site across 1 country: United States