The approval was based on data from 2 multicenter, randomized, double-blind, phase 3 trials (ClinicalTrials.gov: NCT03285477 [N=351] and NCT03285490 [N=351]) that compared the efficacy and safety of Klisyri ointment to placebo in adults with AK on the face or scalp.
Significantly more patients treated with tirbanibulin had complete clearance of lesions at day 57
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The approval was based on data from 2 multicenter, randomized, double-blind, phase 3 trials that evaluated the efficacy and safety of Klisyri ointment in adults with AK on the face or scalp.
The FDA has accepted for filing the New Drug Application for tirbanibulin ointment (formerly known as KX2-391 or KX-01 ointment; Athenex) for the treatment of actinic keratosis (AK).
Fewer patients treated with calcipotriol plus 5-FU developed SCC on treated face, scalp within three years
Fluorouracil more effective than imiquimod, methyl aminolevulinate photodynamic tx, ingenol mebutate
Clinicians and pharmacists who prescribe and fill medications containing the drug are advised to inform patients to avoid exposure to pets.
The Food and Drug Administration (FDA) has approved Ameluz (aminolevulinic acid HCl; Biofrontera) gel, in combination with photodynamic therapy using BF-RhodoLED lamp, for the lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face and scalp.
A considerable proportion of patients with actinic keratosis (AK) receiving long-term topical treatment have poor persistence or adherence, according to a study published online in the British Journal of Dermatology.
