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

Completed · Phase 2

Conditions studied: Actinic Keratosis

In brief

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.

Key facts

Study ID

NCT02305888

Run by

LEO Pharma

People needed

189

Starts

2015-03-01

Expected to finish

2015-08-01

Last updated by the study team

2025-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Long Island Skin Cancer and Dermatologic Surgery — Smithtown, New York, United States

Full record on ClinicalTrials.gov

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