Human Dermal Safety Studies with Eflornithine HCl 13.9% Cream (Vaniqa), a Novel Treatment for Excessive Facial Hair

Eflornithine HCl 13.9% cream (Vaniqa™) was evaluated for dermal safety in four studies involving 230 subjects. The cream was found to cause 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, which was lower than the positive control but higher than the vehicle. Phototoxicity and photocontact allergy studies showed no serious reactions, with mild erythema 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 concluded that eflornithine HCl 13.9% cream had a favorable dermal safety profile suitable for routine topical application.