Conditions: Actinic Keratoses
Keywords: Actinic Keratoses
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 165
Healthy volunteers: no

Brief summary:
In this study the impact of Oleogel-S-10 versus placebo on actinic keratoses over a treatment period of 3 months will be tested. Additionally, once and twice daily applications are tested.

Detailed description:
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.

Arms:
arm 1: Oleogel-S10 100 mg/g ointment for three months once a day (54 patients) arm 2: Oleogel-S10 100 mg/g ointment for three months twice a day (54 patients) arm 3: Placebo (petroleum jelly) for three months once a day (27 patients) arm 4: Placebo (petroleum jelly) for three months twice a day (27 patients)

Interventions: intervention 1: Oleogel-S10 100 mg/g intervention 2: Placebo (petroleum jelly)
Intervention descriptions: intervention 1: topical use once or twice daily intervention 2: topical use once or twice daily

Protocol document: