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

Primary Purpose

Actinic Keratosis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Ingenol mebutate gel 0.05%
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring Actinic Keratosis, Histopathology, Reflectance Confocal Microscopy, Local Skin Reaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southderm Pty Ltd
  • Melanoma Institute Australia
  • The Skin Centre
  • South East Dermatology Centre
  • St John of God Dermatology
  • Burswood Dermatology
  • Klinik für Dermatologie & Allergologie Klinikum Augsburg Süd
  • Collegium Medicum Berlin GmbH
  • Medizinisches Zentrum Bonn Friedensplatz
  • Hautarztpraxis Prof. Dr. med. C. Termeer

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open label active

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
June 23, 2013
Last Updated
April 4, 2016
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01892137
Brief Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
Actinic Keratosis, Histopathology, Reflectance Confocal Microscopy, Local Skin Reaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open label active
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Ingenol mebutate gel 0.05%
Intervention Description
Once daily for 2 consecutive days
Primary Outcome Measure Information:
Title
Clearance of AK
Description
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
Secondary Outcome Measure Information:
Title
Complete clearance of AKs in the Selected Treatment Area
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martina Ulrich
Organizational Affiliation
Collegium Medicum Berlin GmbH, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southderm Pty Ltd
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Melanoma Institute Australia
City
north Sydney
State/Province
New South Wales
ZIP/Postal Code
2060
Country
Australia
Facility Name
The Skin Centre
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
South East Dermatology Centre
City
Carina Heights
State/Province
Queensland
ZIP/Postal Code
4152
Country
Australia
Facility Name
St John of God Dermatology
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Burswood Dermatology
City
Victoria Park
State/Province
Western Australia
ZIP/Postal Code
6100
Country
Australia
Facility Name
Klinik für Dermatologie & Allergologie Klinikum Augsburg Süd
City
Augsburg
ZIP/Postal Code
86179
Country
Germany
Facility Name
Collegium Medicum Berlin GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Medizinisches Zentrum Bonn Friedensplatz
City
Bonn
ZIP/Postal Code
42275
Country
Germany
Facility Name
Hautarztpraxis Prof. Dr. med. C. Termeer
City
Stuttgart
ZIP/Postal Code
70499
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.leopharma.com
Description
LEO Pharma
URL
http://www.tga.gov.au
Description
Therapeutic Goods Administration

Learn more about this trial

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

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