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Contact Sensitization and Phototoxic and Photoallergic Potential of Tirbanibulin 1% Ointment in Healthy Volunteers

Tirbanibulin 1% ointment is approved for the topical treatment of actinic keratosis, applied once daily for 5 days. Three phase 1 randomized, single-center, controlled, within-subject comparison studies were conducted to evaluate the sensitization (KX01-AK-006), phototoxic (KX01-AK-008), and photoallergic (KX01-AK-009) potential of tirbanibulin 1% ointment in healthy adults. In KX01-AK-006 and KX01-AK-009, subjects received repeated applications of tirbanibulin or vehicle for induction (followed by irradiation in KX01-AK-009) and an additional application for the challenge on naïve sites. In KX01-AK-008, subjects received single applications, followed by irradiation. Sensitization was defined as a reaction scoring 3 at naïve sites, recurring at rechallenge. Photoallergy was assessed based on the dermal response of erythema + edema at naïve sites. Phototoxicity was assessed based on the average dermal response score (days 3‒4). Adverse events were collected. In KX01-AK-006, none of the 229 subjects scored 3 at naïve sites. In KX01-AK-008, none of the 31 subjects developed edema, not meeting the criteria for phototoxicity. In KX01-AK-009, none of the 59 subjects showed reactions compatible with photoallergy. Mild-to-moderate contact irritations were reported. The evidence provided by these phase 1 studies showed that tirbanibulin 1% ointment lacks sensitization and phototoxic or photoallergic potential, and supports the safety of its topical application.

 

Comments：

Based on the results of the three phase 1 randomized, single-center, controlled, within-subject comparison studies, tirbanibulin 1% ointment does not appear to have sensitization or phototoxic or photoallergic potential in healthy adults. None of the 229 subjects in KX01-AK-006 scored 3 at naïve sites, none of the 31 subjects in KX01-AK-008 developed edema, and none of the 59 subjects in KX01-AK-009 showed reactions compatible with photoallergy. Mild-to-moderate contact irritations were reported, but overall the evidence supports the safety of tirbanibulin 1% ointment for topical application in the treatment of actinic keratosis. It is important to note, however, that these studies were conducted in healthy adults and further studies may be needed to evaluate the safety of tirbanibulin 1% ointment in other populations or with prolonged use.

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