Data from Pharmawand - Curated by EPG Health - Date added 13 June 2018
Aclaris Therapeutics announced the publication of the two pivotal trials leading to the FDA approval of Eskata (hydrogen peroxide) topical solution, 40% (w/w), for the treatment of raised seborrheic keratoses (SKs) in a prestigious peer-reviewed dermatology journal, the online Journal of the American Academy of Dermatology ahead of print. The article summarized the pivotal results demonstrating the safety and efficacy of ESKATA in treating raised seborrheic keratoses after one to two treatments.
The results show that at day 106, significantly more patients treated with 40% hydrogen peroxide topical solution (HP40) versus alternative treatment achieved Physician’s Lesion Assessment (PLA) scale (0:Clear; 1:Near-Clear; 2:up to 1mm thick, and 3:more than 1mm thick) PLA=0 on all 4 SKs (Study 1: 4% vs 0%; Study 2: 8% vs 0%, P<0.01 both) and 3 of 4 SKs (Study 1: 13% vs 0%; Study 2: 23% vs 0%; P<.0001 both). A higher mean per-patient percentage of SKs were Clear (Study 1: 25% vs 2%; Study 2: 34% vs 1%) and Clear/Near-Clear (Study 1: 47% vs 10%; Study 2: 54% vs 5%) with HP40 versus VEH. Local skin reactions were largely mild and resolved by day 106.
See: “Safety and efficacy of hydrogen peroxide topical solution, 40% (w/w) in patients with seborrheic keratoses: results from two identical, randomized, double-blind, placebo-controlled, Phase III studies (A-101-SEBK-301/302),” Baumann LS et al. Journal of the American Academy of Dermatology (2018; published online June 1, 2018), doi: 10.1016/j.jaad.2018.05.044.