Randomized, Multicenter, Double Blind Study to Compare the Efficacy and Tolerability of Oleogel-S-10 for 3 Month Versus Placebo Only in Patients With Mild to Moderate Actinic Keratoses Located at the Face and Head Oleogel-S-10 in Actinic Keratoses Trial
Oleogel-S-10 has shown efficacy and was well tolerated in two previous clinical trials. In
the second open label phase II trial the efficacy of Oleogel-S-10 alone was similar compared
to a more invasive treatment with cryotherapy. Response rates of 85% with a clear-ance of
more than 75 % of the lesions of the patients treated with Oleogel-S-10 over three months
were reported. These encouraging results led to the present randomized, multicenter, double
blind phase II trial. The efficacy of the treatment shall be tested in a double blind
placebo controlled (petroleum jelly) fashion in order to obtain more reliable results for
the planning of a phase III study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Objective response of the marker actinic keratosis, defined as histologically complete or partial clearance.
Objective response of the marker actinic keratosis, defined as his-tologically complete or partial clearance (partial clearance = down-grading in Cockerell-classification). The marker actinic keratosis is defined as an initially selected lesion within the target area that will be used for final biopsy.
Claus Garbe, Prof. Dr.
Germany: Federal Institute for Drugs and Medical Devices