Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Facies

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

LEO 43204

Daniel M Siegel, MD

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.

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

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

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

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.

Hypertrophic/Hyperkeratotic lesions were identified at baseline (Day 1), Week 4 and Week 8.

Complete clearance was defined as no clinically visible AKs. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic.

LEO Pharma

Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days on the full face or a contiguous area on the chest of approximately 250 cm2.

LEO 43204 0.018% Face/Chest

Treatment with LEO 43204 0.037% gel once daily for 3 consecutive days on the full balding scalp of an area greater than 25 cm2 and up to approximately 250 cm2.

LEO 43204 0.037% Scalp

Treatment with LEO 43204 0.1% gel once daily for 3 consecutive days on a contiguous area of approximately 250 cm2 on trunk or extremities (excluding chest).

LEO 43204 0.1% Trunk/Extremities

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

The baseline analysis population was based on the full analysis set, defined as all participants who assigned to treatment and who met the inclusion criteria.

Clinical Trial Disclosure Specialist

Number of Participants Experiencing DLTs (Dose Limiting Toxicities) Based on LSRs (Local Skin Reactions)

Week 4

Week 8

Percent Reduction in AK Count Excluding Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic

For this efficacy analysis only participants with lesions identified as hypertrophic/hyperkeratotic at baseline were included in the analysis.

Spots Global Cancer Trial Database for Safety of LEO 43204 for Actinic Keratosis Applied on Face/Chest, Scalp and Trunk/Extremities, Respectively

Trial Identification

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Interventions

Study Description

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