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Safety and Tolerability of Different Concentrations of an Ingenol Derivative Field Therapy in the Treatment of Actinic Keratosis

Primary Purpose

Actinic Keratosis

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Ingenol once daily for two consecutive days
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis

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 of non-childbearing potential or if of childbearing potential then negative serum and urine pregnancy test and using effective contraception
  • Ability to provide informed consent

Exclusion Criteria:

  • location of the selected treatment area within 5cm of an incompletely healed wound or within 5cm of a suspected basal cell carcinoma or squamous cell carcinoma
  • undergone Cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to Visit 2
  • use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to Visit 2
  • use of topical moisturisers/creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to visit 2 Treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of Visit 2
  • Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 2 cm of the treatment area in the 8 weeks prior to visit 2
  • use of systemic retinoids
  • those who are currently participating in any other 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

  • Dermatology Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Ingenol mebutate gel 0.05%

Ingenol derivative concentration 1

Ingenol derivative concentration 2

Ingenol derivative concentration 3

Arm Description

once daily for two consecutive days

once daily for two consecutive days

once daily for two consecutive days

once daily for two consecutive days

Outcomes

Primary Outcome Measures

Safety of a new ingenol derivative compared to ingenol mebutate gel applied topically once daily for two consecutive days to four separate treatment areas containing actinic keratosis on the forearm
Safety data to be collected via CRF entries of AEs/SAEs and photographs.

Secondary Outcome Measures

Evaluate treatment responses on Actinic Keratosis of different concentrations of a new ingenol derivative gel compared to the ingenol mebutate gel as assessed by reduction in number of clinically visible selected AK lesions eight weeks after treatment
Assessed by Reflective Confocal Microscopy scoring of visible selected AK lesions

Full Information

First Posted
October 5, 2012
Last Updated
April 3, 2013
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01703078
Brief Title
Safety and Tolerability of Different Concentrations of an Ingenol Derivative Field Therapy in the Treatment of Actinic Keratosis
Official Title
A Phase 1 Exploratory Trial Evaluating Safety and Tolerability of Topical Administration of Different Concentrations of an Ingenol Derivative Compared to Ingenol Mebutate Gel 0.05% Applied on Two Consecutive Days to Four Separate 25cm2 Treatment Areas on the Forearms of Subjects With Actinic Keratosis (Field Therapy)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
April 2013 (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 purpose of this study is to determine if the new ingenol derivative gels are as safe as and as well tolerated as ingenol mebutate gel when applied to AK lesions on the forearm for two consecutive days.
Detailed Description
Various concentrations of new ingenol derivatives will be applied to AKs on the forearms. Reactions and safety will be compared to a US registered and marketed ingenol gel to ascertain if the new ingenol is at least as safe and as well tolerated as the registered ingenol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ingenol mebutate gel 0.05%
Arm Type
Active Comparator
Arm Description
once daily for two consecutive days
Arm Title
Ingenol derivative concentration 1
Arm Type
Experimental
Arm Description
once daily for two consecutive days
Arm Title
Ingenol derivative concentration 2
Arm Type
Experimental
Arm Description
once daily for two consecutive days
Arm Title
Ingenol derivative concentration 3
Arm Type
Experimental
Arm Description
once daily for two consecutive days
Intervention Type
Drug
Intervention Name(s)
Ingenol once daily for two consecutive days
Primary Outcome Measure Information:
Title
Safety of a new ingenol derivative compared to ingenol mebutate gel applied topically once daily for two consecutive days to four separate treatment areas containing actinic keratosis on the forearm
Description
Safety data to be collected via CRF entries of AEs/SAEs and photographs.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Evaluate treatment responses on Actinic Keratosis of different concentrations of a new ingenol derivative gel compared to the ingenol mebutate gel as assessed by reduction in number of clinically visible selected AK lesions eight weeks after treatment
Description
Assessed by Reflective Confocal Microscopy scoring of visible selected AK lesions
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 of non-childbearing potential or if of childbearing potential then negative serum and urine pregnancy test and using effective contraception Ability to provide informed consent Exclusion Criteria: location of the selected treatment area within 5cm of an incompletely healed wound or within 5cm of a suspected basal cell carcinoma or squamous cell carcinoma undergone Cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to Visit 2 use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to Visit 2 use of topical moisturisers/creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to visit 2 Treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of Visit 2 Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 2 cm of the treatment area in the 8 weeks prior to visit 2 use of systemic retinoids those who are currently participating in any other 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
Hans P Soyer
Organizational Affiliation
Dermatology Department, Brisbane Public Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology Department
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia

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

Safety and Tolerability of Different Concentrations of an Ingenol Derivative Field Therapy in the Treatment of Actinic Keratosis

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