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Aminolevulinic acid 10% gel (brand name: Ameluz) is a topical nanoemulsion gel containing 10% aminolevulinic acid hydrochloride as its active ingredient. It is a small molecule photosensitizer precursor used in photodynamic therapy (PDT). Upon topical application, aminolevulinic acid is enzymatically converted intracellularly to protoporphyrin IX (PpIX), which acts as the active photosensitizer. When activated by red light (approximately 635 nm) using a device such as BF-RhodoLED, PpIX generates reactive oxygen species that destroy target cells. Developed by Biofrontera, Ameluz is FDA-approved for the treatment of mild-to-moderate actinic keratosis on the face and scalp, and is approved in Europe for basal cell carcinoma. It is also being evaluated in clinical trials for other dermatological conditions, including an investigational Phase 1 trial for the treatment of onychomycosis of the toenail.
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