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

Actinic Keratosis Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02124239
Study type Interventional
Source LEO Pharma
Contact
Status Completed
Phase Phase 1
Start date April 2014
Completion date November 2014
View Details
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