study to evaluate the efficacy and safety of actikerall® solution in patients with grade i-ii actinic keratoses

Conditions: Actinic Keratosis

Summary: the main purpose of this vehicle-controlled study is to determine the efficacy and safety of a solution of actikerall® (containing 5-fluorouracil 0.5% and salicylic acid 10.0%) in the field-directed treatment of grade i-ii actinic keratosis, when it is applied to the affected area once daily for 12 weeks. a secondary objective of this study is to evaluate the efficacy of actikerall® solution on subclinical actinic keratosis lesions in a subset of patients.


Eligibility criteria:
inclusion criteria: * adult male or non-pregnant, non-lactating (in the last 3 months) female aged between 18 and 85 years (both inclusive). women of childbearing potential will follow specific study requirements. * patients with at least 4 but not more than 10 clinically confirmed actinic keratoses lesions grade i or ii (according to olsen ea et al. 1991) within a field of cancerization of 25 cm² in the face/forehead or bald scalp. * patients with skin type i to iv (according to fitzpatrick skin types) * patients free of any significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment area that may interfere with area examination or final evaluation. * patients in good health condition or free of medical conditions that may interfere with the study results as confirmed by a physical examination, medical history and laboratory analysis. * patients who accept to refrain from sunbathing, intense uv-light exposure and the solarium during the study duration. * patients willing to stop using moisturizers and topical treatments with anti-aging products, vitamins a, c, and/or e containing ointments and gels and green tea preparations in the treatment area. * patients able (physical ability or supportive person) to apply the study preparations correctly and to follow the study procedure and restrictions. * patients with at least 3 subclinical lesions in the 25 cm² test area (field) clearly separated from each other and the actinic keratoses lesions (additional inclusion criteria for the patients participating on the sub-clinical lesions sub-study). exclusion criteria: * subjects that have received treatment for actinic keratoses within the treatment area in the 3 months previous to visit 1 (screening). * subjects that have received prohibited pharmacological or non-pharmacological treatments for any indication other than actinic keratoses within the treatment area before randomization (visit 2). * subjects that have received prohibited systemic treatments for any indication before randomization (visit 2). * subjects taking phenytoin, methotrexate or sulfonylurea. * subjects with dermatological diseases in the treatment area or surrounding area that may be exacerbated by the study treatment or may interfere the study assessments (e.g. psoriasis, eczema). * subjects that have currently malignant or benign tumors of the skin within the treatment area (e.g., malignant melanoma, basal cell carcinoma, squamous cell carcinoma). * subjects that suffer from any kind of photodermatoses. * subjects that have evidence of clinically significant unstable medical conditions. * subjects with known hypersensitivity to any of the trial drugs (5-fluorouracil, salicylic acid), to ingredients of the trial formulation, or to drugs of similar chemical classes * subjects with allergy against dimethylsulfoxide, ethanol, ethyl acetate, pyroxyline, poly(butyl)methacrylate, and/or methylmethacrylate. * subjects with dihydropyrimidine dehydrogenase deficiency (dpd deficiency). * subjects that are currently participating or have participated within the 8 weeks prior to visit 1 in another clinical trial. * patients with known drug or alcohol abuse as assessed by the investigator within the 2 years prior to visit 1. * subject is institutionalized because of legal or regulatory order.