Clinical trial NCT01892137: Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment With Ingenol Mebutate Gel, 0.05%
Official title: Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment With Ingenol Mebutate Gel, 0.05%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
Histopathology
Reflectance Confocal Microscopy
Local Skin Reaction
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2013-07-04
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Must be male or female and at least 18 years of age.
* Female patients must be on non-childbearing potential or if of childbearing potential then negative serum and urine pregnancy test and using effective contraception
* Ability to provide informed consent
* Subjects must have 5-9 clinically typical, visible and discrete AK lesions within a contiguous 25cm2 treatment area on the trunk and extremities except the back of the hand
* AK should be confirmed by histopathology of one of the AK's prior to inclusion

Exclusion Criteria:

* location of the selected treatment area within 5cm of an incompletely healed wound or within 10cm of a suspected basal cell carcinoma or squamous cell carcinoma
* undergone Cosmetic or therapeutic procedures
* use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to Visit 1
* use of topical creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to visit 1.
* treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of visit 1
* treatment with 5-FU, imiquimod, diclofenac, ingenol mebutate of photodynamic therapy within 2cm of the treatment area in the 8 weeks prior to visit 1
* use of systemic retinoids
* those who are currently participating in any other interventional clinical trial
* females who are pregnant or are breastfeeding
* those known or suspected of not being able to comply with the requirements of the protocol or provide consent

Primary outcomes:
measure: Clearance of AK
timeFrame: 8 weeks
Secondary outcomes:
measure: Complete clearance of AKs in the Selected Treatment Area
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Kogarah
country: Australia
facility: Southderm Pty Ltd
state: New South Wales
city: north Sydney
country: Australia
facility: Melanoma Institute Australia
state: New South Wales
city: Benowa
country: Australia
facility: The Skin Centre
state: Queensland
city: Carina Heights
country: Australia
facility: South East Dermatology Centre
state: Queensland
city: Subiaco
country: Australia
facility: St John of God Dermatology
state: Western Australia
city: Victoria Park
country: Australia
facility: Burswood Dermatology
state: Western Australia
city: Augsburg
country: Germany
facility: Klinik für Dermatologie & Allergologie Klinikum Augsburg Süd
city: Berlin
country: Germany
facility: Collegium Medicum Berlin GmbH
city: Bonn
country: Germany
facility: Medizinisches Zentrum Bonn Friedensplatz
city: Stuttgart
country: Germany
facility: Hautarztpraxis Prof. Dr. med. C. Termeer
Study officials:
affiliation: Collegium Medicum Berlin GmbH, Germany
name: Martina Ulrich
role: PRINCIPAL_INVESTIGATOR
References: