Abstract
Chronic prurigo (CP) is a distressing dermatological condition lacking effective topical therapies. This randomized, double-blind, vehicle-controlled trial evaluated the efficacy and safety of Cryosim-1, a TRPM8 agonist cream, in 30 adults with CP. Participants were assigned to apply Cryosim-1 0.1%, 0.5%, or vehicle cream 3 times daily for 4 weeks. Both active formulations significantly reduced Prurigo Activity Score (PAS) compared with vehicle, with 0.1% Cryosim-1 showing a mean PAS reduction of -7.3 (p < 0.001). Significant improvements were observed in 24-h itch intensity, quality of life (DLQI), transepidermal water loss, and stratum corneum hydration. While both concentrations were effective, the 0.1% formulation showed superior tolerability with fewer reports of stinging and erythema. These findings support the potential of TRPM8-targeted therapy in managing CP through dual mechanisms of itch inhibition and skin barrier restoration.