Basal cell carcinoma, unsuitable for surgical treatm

Active Ingredient: Aminolevulinic acid

Indication for Aminolevulinic acid

Population group: only adults (18 - 65 years old)
Therapeutic intent: Curative procedure

Treatment of superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome in adults.

For this indication, competent medicine agencies globally authorize below treatments:

2 sessions of photodynamic therapy with red-light lamp followed by evaluation 3 months later

For:

Dosage regimens

Cutaneous, 1 spreads aminolevulinic acid, one dose, over the duration of 1 week. Afterwards, cutaneous, 1 spreads aminolevulinic acid, one dose, over the duration of 3 months.

Detailed description

For treatment of basal cell carcinoma (BCC), two sessions of photodynamic therapy with red-light lamp shall be administered for one or multiple lesions with an interval of about one week between sessions. Basal cell carcinoma lesions shall be evaluated three months after last treatment. Treated lesions that have not completely resolved after 3 months shall be retreated.

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.

Active ingredient

Aminolevulinic acid

5-Aminolevulinic acid (5-ALA) is a natural biochemical precursor of heme that is metabolised in a series of enzymatic reactions to fluorescent porphyrins, particularly PPIX. 5-ALA synthesis is regulated by an intracellular pool of free heme via a negative feedback mechanism. Administration of excess exogenous 5-ALA avoids the negative feedback control, and accumulation of PPIX occurs in target tissue. In the presence of visible light, fluorescence of PPIX (photodynamic effect) in certain target tissues can be used for photodynamic diagnosis.

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