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

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

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.

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.