Status:
COMPLETED
Safety of LEO 43204 for Actinic Keratosis Applied on Face/Chest, Scalp and Trunk/Extremities, Respectively
Lead Sponsor:
LEO Pharma
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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/extremit...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT02305888
Start Date
March 1 2015
End Date
August 1 2015
Last Update
March 10 2025
Active Locations (1)
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1
Long Island Skin Cancer and Dermatologic Surgery
Smithtown, New York, United States, 11787