Actinic keratosis (AK) MedDRA version: 9.1 Level: LLT Classification code 10000614 Term:
Conditions
Sponsors
Biofrontera Bioscience GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main inclusion criteria: 1) Written Informed Consent 2) Men and women between 18 and 85 years of age 3) 4-8 actinic keratosis 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 will not be considered for a treatment during the planned study. 4) Target actinic keratosis (AK) lesions must be discrete and quantifiable; adjacent AK lesions must show a minimum distance of 1.0 cm from one another 5) Confirmation of AK by biopsy taken at screening 6) Free of significant physical abnormalities (e.g. tattoos, dermatoses) in the potential treatment region that may cause difficulty with examination or final evaluation 7) Willingness to stop the use of moisturizers and any other topical treatments within the treatment region 8) Good general health condition 9) Healthy patients and patients with clinically stable medical conditions including, but not limited to the following diseases (controlled hypertension, diabetes mellitus type II, hypercholesterolemia, osteoarthritis) will be permitted to be included into the study if the medication taken for the treatment of the disease does not match an exclusion criterion or is specified as prohibited concomitant medication 10) No extensive sunbathing or solarium use during the trial 11) Negative pregnancy test at screening 12) Effective contraception in women of childbearing potential Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Main exclusion criteria: 1) Known hypersensitivity to BF-200 ALA, MAL (methyl-aminolevulinic acid) and/or any of the ingredients of the formulations 2) Clinically significant medical conditions (tumor disease etc.) making implementation of the protocol or interpretation of the study results difficult 3) Presence of photodermatoses 4) Presence of other tumors in the treatment areas within the last 4 weeks 5) Intake of phototoxic or photoallergic drugs 6) Current treatment with immunosuppression therapy 7) Hypersensitivity to porphyrins 8) Presence of porphyria 9) Presence of inherited or acquired coagulation defect 10) Any topical treatment within the treatment area within 12 weeks before PDT-1 11) Topical treatment with ALA or MAL outside the treatment area during participation in the study 12) None of the specified systemic treatments within the designated period before PDT-1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of a nanoemulsion gel formulation containing 10% 5-aminolevulinic acid (ALA) as active ingredient (also referred to as BF-200 ALA 10% or BF-200 ALA) with the marketed product Metvix® and with placebo, for the treatment of actinic keratosis with photodynamic therapy.;Secondary Objective: To evaluate the safety and secondary efficacy parameters related to BF-200 ALA 10% gel for treatment of actinic keratosis with photodynamic therapy.;Primary end point(s): The primary efficacy analysis variable is the overall patient complete response rate assessed 12 weeks after the last PDT. A patient is classified as an overall complete responder if all treated lesions are cleared after either PDT-1 or PDT-2, if re-treated. A missing 12-week assessment may be imputed by the preceding 4-week assessment using a last observation carried forward approach. In case no assessment is available at all, the patient will be regarded as a non-responder. | — |
Countries
Austria, France, Germany
Outcome results
None listed