Encore Dermatology Announces Phase 2 Safety Data for Impoyz

A Phase 2, open-label study published in SKIN The Journal of Cutaneous Medicine, found that subjects treated with Impoyz (clobetasol propionate) Cream, 0.025% showed significantly lower mean post-treatment clobetasol propionate plasma concentrations versus the subjects treated with Temovate (clobetasol propionate) Cream, 0.05% (56.3 vs 152.5 pg/mL). Both treatment groups evidenced similar improvements in global psoriasis severity as measured by improvements in the Investigator’s Global Assessment (IGA) from baseline to Day 15. As a result, compared with traditional-dose formulations of clobetasol propionate (0.05%), this data suggests that Impoyz Cream may provide a better safety profile without compromising efficacy. The online article can be accessed here.

Additionally, a lower proportion of subjects in the Impoyz Cream group (12.5%) experienced HPA axis suppression compared to those in the Temovate Cream group (36.4%), although this did not reach statistical significance.

“Impoyz Cream is the first topical clobetasol offering an alternative to the traditional 0.05% clobetasol concentrations, allowing dermatology providers greater flexibility when prescribing high-potency topical corticosteroids,” said Bob Moccia, president and CEO of Encore Dermatology.

The study is a randomized, multicenter, multidose, comparator controlled, open-label study in 50 subjects with moderate to severe plaque psoriasis involving 20 to 50 percent of the body surface area (BSA) at baseline, not including the face, scalp, groin, axillae, and other intertriginous areas. Subjects were randomized (1:1) to treatment with Impoyz Cream or Temovate Cream and instructed to apply study product twice daily for 15 days. The primary safety assessments were the potential for HPA axis suppression and the mean post-treatment clobetasol propionate plasma concentrations before and after the 15-day treatment period.