Active Ingredient: Aminolevulinic acid
Treatment of actinic keratosis of mild to moderate severity (Olsen grade 1 to 2) and of field cancerization in adults.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Cutaneous, 1 spreads aminolevulinic acid, one dose, over the duration of 3 months.
For treatment of actinic keratoses (AK) of the face or scalp, one session of photodynamic therapy (with natural daylight or a red-light or artificial daylight lamp) shall be administered for single or multiple lesions or entire fields with cancerization (areas of skin where multiple AK lesions are surrounded by an area of actinic and sun-induced damage within a limited field).
For treatment of actinic keratoses (AK) in the body region trunk, neck or extremities, one session of narrow-spectrum red-light photodynamic therapy shall be administered. Actinic keratosis lesions or fields shall be evaluated three months after treatment.
Treated lesions or fields that have not completely resolved after 3 months shall be retreated.
Treatment of AK and field cancerization using a red-light lamp:
Aminolevulinic acid gel should be applied to the lesion area or entire cancerized fields and approximately 5 mm of the surrounding area in a film of about 1 mm thickness (about 20 cm² area per tube). The gel should be applied using glove-protected fingertips or a spatula, and it should be allowed to dry for approximately 10 minutes, before a light-tight dressing is placed over the treatment site. Following 3 hours of incubation, the dressing should be removed and the remnant gel wiped off. The gel can be administered to healthy skin around the lesions. Direct contact of the gel with the eyes or mucous membranes should be avoided (keep a distance of 1 cm). In case of accidental contact, rinsing with water is recommended.
Treatment of AK and field cancerization of the face and scalp with natural or artificial daylight:
A thin layer of aminolevulinic acid gel should be applied to the lesion area or entire cancerized fields and approximately 5 mm of the surrounding area using glove-protected fingertips or a spatula. No occlusive dressing is necessary during incubation. It can be used optionally for artificial daylight PDT, but it should be removed before illumination at the latest. The gel can be administered to healthy skin around the lesions. Direct contact of the gel with the eyes or mucous membrane should be avoided (keep a distance of 1 cm). In case of accidental contact, rinsing with water is recommended. The gel should not be wiped off during the entire daylight PDT.
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