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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

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

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

NCT ID

NCT02361216

First Posted

February 2, 2015

Last Updated

October 2, 2018

Sponsor

LEO Pharma

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

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

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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