Evaluation of Safety and Efficacy of BF-200 ALA for the Treatment of Actinic Keratosis With Photodynamic Therapy
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: BF-200 ALA; MAL Cream; Vehicle
Intervention description: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.; topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.; topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.
Intervention MeSH terms: Aminolevulinic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 571.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The aim of the study is to evaluate the non-inferiority of BF-200 ALA (Ameluz) in the
      treatment of actinic keratosis (AK) with photodynamic therapy (PDT) compared to Metvix.
    

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