The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses

Inclusion Criteria: * At least two mild to moderate actinic keratoses located at the facial skin or the head (except lips) * Actinic keratoses with a diameter of 0,5 - 2 cm, * that are definitely distinguished from other lesions and display a minimum distance of 0,5 cm to neighbored lesions * that are evaluated as histopathological grade 1 to 3 * histologically proven AK within three months before study entry * prepared and able to give written informed consent * ≥ 18 years of age * In case of females: postmenopause defined as * natural menopause with menses \> 1 year ago * serum FSH (\> 20 IU/l) and E2 levels in the postmenopausal range or * patients who had bilateral oophorectomy * prepared and comply with all study requirements, including the following: * application of Oleogel-S10 on the treatment area once or twice a day * 4 clinic visits during the pre-study, treatment, post-treatment, and follow-up period * pre- and post-treatment biopsy for histological confirmation (of clearance) of AK-diagnosis * Representative histologic slide and tissue block were shipped Exclusion Criteria: * Active immunosuppressive therapy * data of clinically significant, unstable, cardiovascular or hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or diseases Note: Patients with clinically stable medical conditions including, but not limited to, controlled hypertension, diabetes mellitus type II, hypercholesterolemia, or osteoarthritis will be allowed to enter the study * known allergies to any excipient in the study drug * any dermatological disease and/or condition in the treatment or surrounding area (3 cm distances from treatment area) that may be exacerbated by treatment with Oleogel-S-10 or cause difficulty with examination * active chemical dependency or alcoholism, as assessed by the investigator * pregnant and lactating women * currently participating in another clinical study or have completed another clinical study with an investigational drug within the past 30 days * received topical treatment at the treatment area with diclofenac gel, imiquimod or 5-FU within a time period of 1 month * Concomitant existence of non-treated (non-excised) basal cell carcinoma, squamous cell carcinoma or malignant melanoma * Invasive tumors within the treatment area, e.g.: merkel cell carcinoma, squamous cell carcinoma, basal cell carcinoma, the latter is accepted if completely surgically removed Note: A biopsy of any lesion within the treatment or surrounding area suggestive of malignancy should be performed at the pre-study screening visit. If invasive SCC or other malignant conditions are confirmed within the treatment area, the patient will not be included in the study.