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This is an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel groups will be enrolled. The trial includes three active treatment groups. To be eligible for inclusion in this trial, subjects must have at least 15 clinically typical, visible, and discrete actinic keratosis (AKs) on the face, scalp or on the arm within a contiguous area of approximately 250 cm2 of sun-damaged skin.
There will be 3 treatment groups: (1) once daily application of LEO43204 gel 0.018% on the full face for three consecutive days, (2) once daily application of LEO43204 gel 0.1% on the arm on a treatment area of approximately 250 cm2 for three consecutive days and , (3) once daily application of LEO43204 gel 0.037 % on the scalp for three consecutive days.
Enrollment
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Inclusion criteria
Subjects with 15 or more clinically typical, visible and discrete AKs on either:
Subject at least 18 years of age.
Female subjects of childbearing potential* must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment.
Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until completion.
Exclusion criteria
Location of the treatment area (full face, full balding scalp, chest, trunk or extremities)
Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO 43204 programme.
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).
Primary purpose
Allocation
Interventional model
Masking
60 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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