Eflornithine HCl 13.9% cream (Vaniqa™) was evaluated for dermal safety in four studies involving 230 subjects. The cream caused erythema with oedema in 38.9% of subjects, compared to 4.8% with the vehicle cream. In a cumulative irritation study with 30 subjects, the cream had a mean irritation score of 1.33, lower than the positive control but higher than the vehicle. Phototoxicity and photocontact allergy studies showed mild or no reactions, with effects subsiding within 24 hours. No serious adverse events were reported, and the cream did not exhibit contact sensitizing, photocontact allergic, or phototoxic properties. It was deemed to have a favorable dermal safety profile for routine use.
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January 2000 in “Current Medical Research and Opinion” Eflornithine HCl 13.9% cream (Vaniqa™) was evaluated for dermal safety in four studies involving 230 subjects. The cream caused erythema with oedema in 38.9% of subjects, compared to 4.8% with the vehicle cream. In a cumulative irritation study with 30 subjects, the cream had a mean irritation score of 1.33, lower than the positive control but higher than the vehicle. Phototoxicity and photocontact allergy studies showed mild or no reactions, with effects subsiding within 24 hours. No serious adverse events were reported, and the cream did not exhibit contact sensitizing, photocontact allergic, or phototoxic properties. It was deemed to have a favorable dermal safety profile for routine use.
