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