The main purpose of this trial is to demonstrate the predictive value of the clinical diagnosis of clearance of Actinic Keratoses after treatment with Ingenol Mebutate using histopathological examination as the standard.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
137
Once daily for 2 consecutive days
Southderm Pty Ltd
Kogarah, New South Wales, Australia
Melanoma Institute Australia
North Sydney, New South Wales, Australia
The Skin Centre
Benowa, Queensland, Australia
Clearance of AK
The primary response criterion is the clinical and histological clearance of AK at Day 57. Clinical Clearance will be measured by counting AKs, and histological clearance will be by performing a biopsy (result reported as AK or not AK).
Time frame: 8 weeks
Complete clearance of AKs in the Selected Treatment Area
Efficacy in terms of complete clearance of AKs in the STA and histological clearance of pre-identified lesion. AK clearance will be determined by AK count. Clearance of the pre-identified lesion will be assessed by a histopatholgist from a biopsy sample and reported as AK or not AK.
Time frame: 8 weeks
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South East Dermatology Centre
Carina Heights, Queensland, Australia
St John of God Dermatology
Subiaco, Western Australia, Australia
Burswood Dermatology
Victoria Park, Western Australia, Australia
Klinik für Dermatologie & Allergologie Klinikum Augsburg Süd
Augsburg, Germany
Collegium Medicum Berlin GmbH
Berlin, Germany
Medizinisches Zentrum Bonn Friedensplatz
Bonn, Germany
Hautarztpraxis Prof. Dr. med. C. Termeer
Stuttgart, Germany