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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01892137
First received: June 23, 2013
Last updated: July 1, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Actinic Keratosis
Drug: Ingenol mebutate gel 0.05%
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment With Ingenol Mebutate Gel, 0.05%

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Clearance of AK [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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:
  • Complete clearance of AKs in the Selected Treatment Area [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 137
Study Start Date: July 2013
Study Completion Date: May 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Open label active Drug: Ingenol mebutate gel 0.05%
Once daily for 2 consecutive days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01892137

Locations
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
Germany
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
Investigators
Principal Investigator: Martina Ulrich Collegium Medicum Berlin GmbH, Germany
  More Information

Additional Information:
No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01892137     History of Changes
Other Study ID Numbers: LP0041-62
Study First Received: June 23, 2013
Last Updated: July 1, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by LEO Pharma:
Actinic Keratosis
Histopathology
Reflectance Confocal Microscopy
Local Skin Reaction

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Neoplasms
Precancerous Conditions
Skin Diseases

ClinicalTrials.gov processed this record on October 22, 2014