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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: Ingenol Mebutate
* Other: Vehicle


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ingenol mebutate gel<br>Treatment once daily for 3 days | Drug: Ingenol Mebutate<br> <br> |
| Placebo Comparator: Vehicle<br>Treatment once daily for 3 days | Other: Vehicle<br>* Vehicle gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 
| 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. | 4 weeks | 
| Percent Reduction From Baseline in AK Count | Percent reduction in AK count in the selected treatment area at Week 8 | 8 weeks |