LAS41005 in Hyperkeratotic Actinic Keratosis

A Prospective Comparator Controlled Randomized Exploratory Study on the Efficacy of LAS 41005 Compared to Cryotherapy in Subjects With Hyperkeratotic Actinic Keratosis

The aim of this study is to evaluate the efficacy and safety of LAS 41005 compared to cryotherapy in subjects with moderate to severe hyperkeratotic actinic keratosis (punch biopsies).

Main Inclusion Criteria:

• Signed and dated written informed consent.
• Men and women aged between 18 and 85 years inclusive.
• Have a general good and stable health condition as confirmed by a physical examination and by medical history.
• Have at least 4 but not more than 10 clinically confirmed hyperkeratotic AK target lesions of moderate to severe intensity within the face/forehead or bald scalp
• Skin type I to IV according to Fitzpatrick's .
• Are free of any significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment area that may cause difficulty with examination or final evaluation.
• Physical ability to apply the study preparation correctly and to follow the study restrictions and visit.
• Women of childbearing potential are allowed to participate in this study, only if they use a highly effective method of contraception

Main Exclusion Criteria:

• Have received treatment of AK within the treatment area (face / scalp) in the three months preceding this clinical trial.
• Have known hypersensitivity to the ingredients
• Are subjects under immunosuppressive therapy.
• Having coagulation defects which are inherited or acquired
• Have evidence of clinically significant, unstable medical conditions
• Have currently other malignant or benign tumors of the skin within the treatment area
• Subjects who have taken topical or systemic treatments that might interfere with the study end points, within a time window that is not allowed, or who are currently taking phenytoin, methotrexate or sulfonylurea.
• Subjects taking inhibitors of DPD (e.g. Brivudin, Sorivudin)
• Are known to be pregnant or lactating (currently or within the past 3 months).
• Have any dermatological disease in the treatment area or surrounding area that may be exacerbated by treatment
• Are currently or within the past 8 weeks participating in another clinical study.
• Have active chemical dependency or alcoholism as assessed by the investigator.
• Subject is institutionalized because of legal or regulatory order.