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About
This was a placebo controlled, double blind, randomized phase II dose-response study to evaluate the efficacy and safety of BF-200 ALA (containing the active ingredient 5 - aminolevulinic acid- ALA) used with photodynamic therapy (PDT) in patients with actinic keratosis (AK).
Full description
The study was performed to define the effective therapeutic dose of the active pharmaceutical ingredient (ALA) in a nanoemulsion formulation in the treatment of actinic keratosis (AK) with topical PDT and to assess the efficacy of topical PDT with a new nanoemulsion formulation of ALA in the treatment of AK. The efficacy of BF-200 ALA was calculated by the AK clearance rate, defined as the proportion of AK lesions showing complete remission 12 weeks after PDT treatment.
Subjects of two study centres provided plasma and urine samples for the quantification of ALA and its metabolite, the active photosensitizer protoporphyrin IX (PpIX).
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
Had a known hypersensitivity to ALA.
Had received any other medication known to affect AK 3 months before or during the study.
Were under immunosuppressive therapy.
Suffered from porphyria.
Showed hypersensitivity to porphyrins.
Suffered from photodermatoses.
Had inherited or acquired coagulation defects.
Received medication with hypericin or systemically acting drugs with phototoxic or photoallergic potential within 8 weeks prior to treatment with study drug and PDT
Had evidence of clinically significant, unstable medical conditions such as
Subjects with clinically stable medical conditions including, but not limited to the following diseases were allowed to be included into the study, if the medication taken for the treatment of the disease did not match the criteria of the excluded or disallowed medications listed in points 11 and 12 below:
Had currently other malignant or benign tumours of the skin within the treatment area (e.g., malignant melanoma, basal cell carcinoma, squamous cell carcinoma).
Had received the following treatments for any indication in the treatment area within the designated time period before PDT treatment with ALA:
Topical steroids - 4 weeks
Topical retinoids - 6 weeks
Topical diclofenac preparations - 6 weeks
Topical 5-fluorouracil preparations - 6 weeks
Topical immunomodulators - 6 weeks
Surgical excision (except biopsy for diagnostic confirmation) - 6 weeks
Curettage - 4 weeks
Cryo-, thermo- or chemodestruction - 6 weeks
PDT - 6 weeks
Therapeutic UV-Radiation - 6 weeks
Had received the following systemic treatments within the designated period before PDT treatment with ALA:
Interferon - 6 weeks
Immunomodulators or immunosuppressive therapies - 10 weeks
Cytotoxic drugs - 6 months
Investigational drugs - 8 weeks
Drugs known to have major organ toxicity - 8 weeks
Corticosteroids (oral or injectable) - 6 weeks
Inhaled corticosteroids (>1200 µg/day for beclomethasone, or >600 µg/day for fluticasone) - 4 weeks
A previous treatment with ALA.
Known allergy to polysorbate 80, caprylic/capric acid triglycerides, isopropyl alcohol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, propylene glycol, methyl parahydroxybenzoate, or propyl parahydroxybenzoate.
Were known to be pregnant or lactating (currently or within the past 3 months).
Had any dermatological disease in the treatment area or surrounding area that might be exacerbated by treatment with topical ALA or cause difficulty with examination (e.g. psoriasis, eczema).
Show cornu cutaneum like alterations of the skin in the face or on the bald scalp (target area).
Were currently or within the past 8 weeks participating in another clinical study.
Had active chemical dependency or alcoholism as assessed by the investigator.
Primary purpose
Allocation
Interventional model
Masking
105 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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