Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT02289768
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02289768
Study Brief:
Protocol Section:
NCT02289768