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.
Interventional
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.
18 weeks
Yes
Claus Garbe, Prof. Dr.
Principal Investigator
Universitätshautklinik Tübingen
Germany: Federal Institute for Drugs and Medical Devices
5006000
NCT00786994
October 2008
November 2010
Name | Location |
---|