Safety of LEO 43204 for Actinic Keratosis Applied on Face/Chest, Scalp and Trunk/Extremities, Respectively
Actinic Keratosis
About this trial
This is an interventional treatment trial for Actinic Keratosis
Eligibility Criteria
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).
Sites / Locations
- Long Island Skin Cancer and Dermatologic Surgery
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
LEO 43204, 0.018% once daily for 3 days
LEO 43204, 0.037% once daily for 3 days
LEO 43204, 0.1% once daily for 3 days