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Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest

Primary Purpose

Actinic Keratosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ingenol Mebutate
Vehicle
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 SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects with 5 to 20 clinically typical, visible and discrete, actinic keratosis (AKs) non-hyperkeratotic and non-hypertrophic AKs within a selected treatment area of sun-damaged skin on either:

  • The full face
  • The full balding scalp
  • A contiguous area of approximately 250 cm2 on the chest

Exclusion Criteria:

  • Location of the treatment area (full face, full balding scalp or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC).
  • Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO clinical programme on ingenol mebutate gel for larger treatment areas.
  • Treatment with ingenol mebutate gel in the selected treatment area within the last 12 months.
  • Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous horn) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).

Sites / Locations

  • Laser & Skin Surgery Center of Indiana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ingenol mebutate gel

Vehicle

Arm Description

Treatment once daily for 3 days

Treatment once daily for 3 days

Outcomes

Primary Outcome Measures

Percentage of Participants With Complete Resolution of Actinic Keratosis (AK)
Complete resolution of actinic keratosis (AKclear100) at Week 8 is defined as 100% reduction from baseline in the number of clinically visible AKs

Secondary Outcome Measures

Percentage of Participants With Partial Clearance at Week 8
Partial clearance (AKclear75 ) is defined as a reduction in the number of clinically visible AKs in the selected treatment area by at least 75% compared to baseline.
Percentage of Participants With Partial Clearance at Week 4
Partial clearance (AKclear75) defined as a reduction in the number of clinically visible AKs in the selected treatment area by at least 75% compared to baseline.
Percent Reduction From Baseline in AK Count
Percent reduction in AK count in the selected treatment area at Week 8

Full Information

First Posted
February 2, 2015
Last Updated
October 2, 2018
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT02361216
Brief Title
Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest
Official Title
Efficacy and Safety of Ingenol Mebutate Gel in Field Treatment of Actinic Keratosis on Full Face, Balding Scalp or Approximately 250 cm2 on the Chest
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2017 (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 objective of the trial is to investigate efficacy and safety of ingenol mebutate gel for actinic keratosis applied to large treatment areas once daily for three consecutive days on face, scalp or chest.

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
729 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ingenol mebutate gel
Arm Type
Experimental
Arm Description
Treatment once daily for 3 days
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Treatment once daily for 3 days
Intervention Type
Drug
Intervention Name(s)
Ingenol Mebutate
Intervention Type
Other
Intervention Name(s)
Vehicle
Intervention Description
Vehicle gel
Primary Outcome Measure Information:
Title
Percentage of Participants With Complete Resolution of Actinic Keratosis (AK)
Description
Complete resolution of actinic keratosis (AKclear100) at Week 8 is defined as 100% reduction from baseline in the number of clinically visible AKs
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With Partial Clearance at Week 8
Description
Partial clearance (AKclear75 ) is defined as a reduction in the number of clinically visible AKs in the selected treatment area by at least 75% compared to baseline.
Time Frame
8 weeks
Title
Percentage of Participants With Partial Clearance at Week 4
Description
Partial clearance (AKclear75) defined as a reduction in the number of clinically visible AKs in the selected treatment area by at least 75% compared to baseline.
Time Frame
4 weeks
Title
Percent Reduction From Baseline in AK Count
Description
Percent reduction in AK count in the selected treatment area at Week 8
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects with 5 to 20 clinically typical, visible and discrete, actinic keratosis (AKs) non-hyperkeratotic and non-hypertrophic AKs within a selected treatment area of sun-damaged skin on either: The full face The full balding scalp A contiguous area of approximately 250 cm2 on the chest Exclusion Criteria: Location of the treatment area (full face, full balding scalp or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC). Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO clinical programme on ingenol mebutate gel for larger treatment areas. Treatment with ingenol mebutate gel in the selected treatment area within the last 12 months. Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous horn) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. William Hanke, MD
Organizational Affiliation
Laser & Skin Surgery Center of Indiana,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laser & Skin Surgery Center of Indiana
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest

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