Vaniqa Safety

Dermal safety of 13.9 % eflornithine cream Vaniqa was assessed in women in four open – label, vehicle-control studies performed by Hickman et al. [61]. The studies included con­tact sensitization study (230 subjects), a cumulative irritation test (30 subjects), a phototoxicity assessment (25 subjects), and a photocontact allergy study (30 subjects). The data showed that eflornithine cream Vaniqa™ does not have contact sensitizing, photocontact allergic or phototoxic properties. However, under the exaggerated conditions of use, the drug was found to cause some skin irritation. Phase-III clinical trials involving 1967 women in blinded vehicle-control studies (594 subjects), and vehicle control and open label studies (1373 subjects), showed that adverse events for most body systems occurred at similar frequency between the drug and the control groups (Rx Vaniqa package insert). The most frequent treatment-related adverse events were dermal effects at the site of application. A high incidence of acne, 21.3% in the Vaniqa group and 21.4% in the vehicle-control group, indicated that the cream vehicle had comedogenic potential. The treatment-related skin stinging was higher in the Vaniqa™ group (7.9%) than the vehicle control group (2.5%).