the efficacy and tolerability of oleogel-s-10 in patients with actinic keratoses

Conditions: Actinic Keratoses

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.

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.

Eligibility criteria:
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.

Keywords: actinic keratoses