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 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT02799069
Eligibility Criteria:
Main Inclusion Criteria:
* Written informed consent.
* Men and women between 18 and 85 years of age.
* 4-8 AK lesions of 0.5 to 1.5 cm diameter of mild to moderate intensity (Olsen grade 1 and 2) in the face and/or on the bald scalp. Lesions on the eyes, nostrils, ears and mouth were not considered for treatment during the planned study.
* Target AK lesions were to be discrete and quantifiable; adjacent AK lesions were to show a minimum distance of 1.0 cm from one another.
* Confirmation of AK by biopsy taken at screening.
* Free of significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment region that could have caused difficulty with examination or final evaluation.
* Willingness to stop the use of moisturizers and any other topical treatments within the treatment region.
* Good general health condition.
* Healthy subjects and subjects with clinically stable medical conditions including, but not limited to the following diseases (controlled hypertension, diabetes mellitus type II, hypercholesterolemia, osteoarthritis) were permitted to be included in the study if the medication taken for the treatment of the disease did not match an exclusion criterion or was not specified as prohibited concomitant medication.
* No extensive sunbathing or solarium use during the trial.
* Negative pregnancy test at screening.
Main exclusion criteria:
* Known hypersensitivity to BF-200 ALA, MAL (methyl-aminolevulinic acid) and/or any of the ingredients of the formulations
* Clinically significant medical conditions (tumor disease etc.) making implementation of the protocol or interpretation of the study results difficult
* Presence of photodermatoses
* Presence of other tumors in the treatment areas within the last 4 weeks
* Start of treatment with phototoxic or photoallergic drugs within 8 weeks prior to screening
* Current treatment with immunosuppression therapy
* Hypersensitivity to porphyrins
* Presence of porphyria
* Presence of inherited or acquired coagulation defect
* Any topical treatment within the treatment area within 12 weeks before PDT1 (first PDT Treatment)
* Topical treatment with ALA or MAL outside the treatment area during participation in the study
* None of the specified systemic treatments within the designated period before PDT1
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02799069
Study Brief:
Protocol Section:
NCT02799069