Pharmacokinetics of Ingenol Mebutate Gel in Actinic Keratosis Under Maximum Use Conditions
Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
Participant gender:
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.