Denver — In the search for rosacea treatments, topical ivermectin 1 percent cream met its safety endpoints in two pivotal trials that included a total of 910 actively treated subjects, Galderma announced at the 72nd Annual Meeting of the American Academy of Dermatology.
"Currently, there are a limited number of safe and efficacious topical medications available to treat chronic papulopustular rosacea," says Stuart Raetzman, Galderma CEO and vice president, North America. "We at Galderma are hopeful that the positive phase 3 data from the ivermectin 1 percent studies will lead to an additional effective treatment option for our healthcare provider partners."
In each study, patients applied the cream once daily for 12 weeks. Investigators observed treatment onset at week four in each study (among ivermectin-treated patients, 10.9 and 5.6 percent achieved success at this juncture, compared to 1 percent of vehicle-treated patients). At 12 weeks, 38.4 percent of treated patients in study 1 were assessed as successful, versus 11.6 percent treated with vehicle (p<0.001). Additionally, ivermectin-treated patients overall achieved an average reduction of more than 20 lesions, versus 12 and 13.4 lesions in the control groups.
Regarding safety, in the two studies, 4.2 and 2.6 percent, respectively, of treated patients experienced treatment-related adverse events (AEs), versus 7.8 and 6.5 percent in the vehicle groups. The most common treatment-related AEs were a burning sensation and pruritus, neither of which occurred in more than 2.6 percent of any treated or untreated group.