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

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 Overview

• Status: Completed
• Conditions: Actinic Keratosis
• Intervention / Treatment: Drug: Ingenol mebutate gel 0.05%

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Open label active	Drug: Ingenol mebutate gel 0.05%; Once daily for 2 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Principal Investigator: Martina Ulrich, Collegium Medicum Berlin GmbH, Germany

Publications and helpful links

Helpful Links

• Therapeutic Goods Administration
• LEO Pharma

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: June 23, 2013
• First Submitted That Met QC Criteria: June 30, 2013
• First Posted (Estimate): July 4, 2013

Study Record Updates

• Last Update Posted (Estimate): April 5, 2016
• Last Update Submitted That Met QC Criteria: April 4, 2016
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Actinic Keratosis; Histopathology; Reflectance Confocal Microscopy; Local Skin Reaction
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: LP0041-62