Safety of LEO 43204 for Actinic Keratosis Applied on Face/Chest, Scalp and Trunk/Extremities, Respectively

Study Overview
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Brief Summary
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The objective of the trial is to investigate the Safety of LEO 43204 0.018%, 0.037% and 0.1% for actinic keratosis applied once daily for three consecutive days on face/chest, scalp and trunk/extremities, respectively.

Official Title
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Safety of LEO 43204 0.018%, 0.037% and 0.1% for Actinic Keratosis Applied Once Daily for Three Consecutive Days on Face/Chest, Scalp and Trunk/Extremities, Respectively

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: LEO 43204


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with 5 to 20 clinically typical, visible and, discrete, nonhyperkeratotic 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 trunk or extremities 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 SCC. Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO 43204 programme. 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 horns) 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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEO 43204, 0.018% once daily for 3 days<br> | Drug: LEO 43204<br>* Treatment of actinic keratosis<br>|
| Experimental: LEO 43204, 0.037% once daily for 3 days<br> | Drug: LEO 43204<br>* Treatment of actinic keratosis<br>|
| Experimental: LEO 43204, 0.1% once daily for 3 days<br> | Drug: LEO 43204<br>* Treatment of actinic keratosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing DLTs (Dose Limiting Toxicities) Based on LSRs (Local Skin Reactions) | For face/chest, a DLT was defined as one or more of the following three LSRs: Crusting Grade 4 Erosion/Ulceration Grade 4 Vesiculation/Pustulation Grade 4 Or two or more of the following five LSRs: Erythema Grade 4 Crusting Grade 3 Swelling Grade 4 Erosion/Ulceration Grade 3 Vesiculation/Pustulation Grade 3 For scalp a DLT was defined as erosion/ulceration Grade 4 For trunk/extremities a DLT was defined as one or more of the following three LSRs: Crusting Grade 4 Erosion/Ulceration Grade 4 Vesiculation/Pustulation Grade 4 Or two or more of the following four LSRs: Crusting Grade 3 Swelling Grade 4 Erosion/Ulceration Grade 3 Vesiculation/Pustulation Grade 3 | 8 days / From baseline (Day 1) to Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Reduction in AK Count Excluding Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic | The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at baseline (Day 1), Week 4, and Week 8. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic. | 4 weeks and 8 weeks / From baseline to Week 4, and Week 8 | 
| Percent Reduction in AK Count of Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic | Hypertrophic/Hyperkeratotic lesions were identified at baseline (Day 1), Week 4 and Week 8. | 4 weeks and 8 weeks / From baseline to Week 4, and Week 8 | 
| Percentage of Participants With Complete Clearance of AKs | Complete clearance was defined as no clinically visible AKs. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic. | 8 weeks |