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Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment With Ingenol Mebutate Gel, 0.05%

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01892137
Recruitment Status : Completed
First Posted : July 4, 2013
Last Update Posted : April 5, 2016
Information provided by (Responsible Party):
LEO Pharma

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.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: Ingenol mebutate gel 0.05% Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment With Ingenol Mebutate Gel, 0.05%
Study Start Date : July 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Open label active Drug: Ingenol mebutate gel 0.05%
Once daily for 2 consecutive days

Primary Outcome Measures :
  1. Clearance of AK [ Time Frame: 8 weeks ]
    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).

Secondary Outcome Measures :
  1. Complete clearance of AKs in the Selected Treatment Area [ Time Frame: 8 weeks ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01892137

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Australia, New South Wales
Southderm Pty Ltd
Kogarah, New South Wales, Australia, 2217
Melanoma Institute Australia
north Sydney, New South Wales, Australia, 2060
Australia, Queensland
The Skin Centre
Benowa, Queensland, Australia, 4217
South East Dermatology Centre
Carina Heights, Queensland, Australia, 4152
Australia, Western Australia
St John of God Dermatology
Subiaco, Western Australia, Australia, 6008
Burswood Dermatology
Victoria Park, Western Australia, Australia, 6100
Klinik für Dermatologie & Allergologie Klinikum Augsburg Süd
Augsburg, Germany, 86179
Collegium Medicum Berlin GmbH
Berlin, Germany, 10117
Medizinisches Zentrum Bonn Friedensplatz
Bonn, Germany, 42275
Hautarztpraxis Prof. Dr. med. C. Termeer
Stuttgart, Germany, 70499
Sponsors and Collaborators
LEO Pharma
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Principal Investigator: Martina Ulrich Collegium Medicum Berlin GmbH, Germany

Additional Information:
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Responsible Party: LEO Pharma Identifier: NCT01892137    
Other Study ID Numbers: LP0041-62
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: March 2015
Keywords provided by LEO Pharma:
Actinic Keratosis
Reflectance Confocal Microscopy
Local Skin Reaction
Additional relevant MeSH terms:
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Keratosis, Actinic
Skin Diseases
Precancerous Conditions