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Safety and Dose Finding Study of New Vehicle Formulations Containing Ingenol Mebutate to Treat Actinic Keratosis on the Forearm

Primary Purpose

Actinic Keratosis

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

once daily for two consecutive days (Picato)

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 the treatment visit
presence of sunburn within the selected treatment areas
use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to the treatment visit
previous enrolment in this clinical trial
prior treatment with ingenol mebutate on the forearms
use of topical moisturisers/creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to the treatment visit
treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of the treatment visit
treatment with 5-FU, imiquimod, diclofenac,or photodynamic therapy within 2 cm of the treatment area in the 8 weeks prior to the treatment visit
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 or not being able to comply with the requirements of the protocol or provide consent

Sites / Locations

Dermatology Department
Specialist Connect

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

Picato® 0.05% gel

ingenol mebutate vehicle formulation 1

ingenol mebutate vehicle formulation 2

ingenol mebutate vehicle formulation 3

Arm Description

once daily for two consecutive days

Outcomes

Primary Outcome Measures

Safety of 3 new vehicle formulations containing ingenol mebutate compared to Picato® 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. Relative skin reactions for comparison to Picato®.

Secondary Outcome Measures

Evaluate treatment responses on AK of selected concentration of ingenol mebutate containing vehicle formulation from Part 1 compared to Picato® gel as assessed by reduction in the number of selected AK lesions 2 months after treatment

Assessed by visible and imaged lesion count

Full Information

NCT ID

NCT01803477

First Posted

February 28, 2013

Last Updated

September 8, 2014

Sponsor

LEO Pharma

1. Study Identification

Unique Protocol Identification Number

NCT01803477

Brief Title

Safety and Dose Finding Study of New Vehicle Formulations Containing Ingenol Mebutate to Treat Actinic Keratosis on the Forearm

Official Title

A Seamless Phase 1/2 Exploratory Multi-centre, Investigator-blind, Dose Escalation Study (Study Part 1), Followed by a Randomised, Intra-subject, Active Controlled Efficacy Study of Different Ingenol Mebutate Formulations Applied to the Forearm for 2 Consecutive Days (Study Part 2)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LEO Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine if the new vehicle formulations containing ingenol mebutate are as safe and effective as Picato® gel 0.05% (it's current vehicle formulation) when applied to AK lesions on the forearm for two consecutive days.

Detailed Description

This study will be run in 2 parts. The first part involves applying escalating concentrations of the new vehicle formulations containing ingenol mebutate to AKs on the forearms. Reactions and safety will be compared to Picato® (a registered and marketed ingenol mebutate gel) to ascertain if the new vehicle formulations are at least as safe and effective as Picato® . The purpose of part 2 is to select the concentration in the "new formulation" that produces this same, if not better response, as Picato® and with a similar or better safety profile.

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, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Picato® 0.05% gel

Arm Type

Active Comparator

Arm Description

once daily for two consecutive days

Arm Title

ingenol mebutate vehicle formulation 1

Arm Type

Experimental

Arm Description

once daily for two consecutive days

Arm Title

ingenol mebutate vehicle formulation 2

Arm Type

Experimental

Arm Description

once daily for two consecutive days

Arm Title

ingenol mebutate vehicle formulation 3

Arm Type

Experimental

Arm Description

once daily for two consecutive days

Intervention Type

Drug

Intervention Name(s)

once daily for two consecutive days (Picato)

Other Intervention Name(s)

Picato® 0.05% gel, escalating doses of ingenol mebutate vehicle formulation 1, escalating doses of ingenol mebutate vehicle formulation 2, escalating doses of ingenol mebutate vehicle formulation 3

Primary Outcome Measure Information:

Title

Description

Safety data to be collected via CRF entries of AEs/SAEs and photographs. Relative skin reactions for comparison to Picato®.

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Description

Assessed by visible and imaged lesion count

Time Frame

2 months

Other Pre-specified Outcome Measures:

Title

Safety of the new ingenol mebutate vehicle formulation (ascertained in Part 1) compared to Picato® gel applied topically once daily for 2 consecutive days to 4 separate treatment areas containing actinic keratosis on the forearm

Description

Safety data to be collected via CRF entries of AEs/SAEs and photographs. Treatment responses 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

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 the treatment visit presence of sunburn within the selected treatment areas use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to the treatment visit previous enrolment in this clinical trial prior treatment with ingenol mebutate on the forearms use of topical moisturisers/creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to the treatment visit treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of the treatment visit treatment with 5-FU, imiquimod, diclofenac,or photodynamic therapy within 2 cm of the treatment area in the 8 weeks prior to the treatment visit 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 or not being able to comply with the requirements of the protocol or provide consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lynda Spelman, MD

Organizational Affiliation

Specialist Connect

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hans P Soyer, MD

Organizational Affiliation

Dermatology Department, Princess Alexandra Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dermatology Department

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Specialist Connect

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 Dose Finding Study of New Vehicle Formulations Containing Ingenol Mebutate to Treat Actinic Keratosis on the Forearm

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