The following is a summary of “Efficacy and safety of crisaborole ointment, 2%, in participants aged ≥45 years with stasis dermatitis: Results from a fully decentralized, randomized, proof-of-concept phase 2a study,” published in the May 2024 issue of Dermatology by Silverberg, et al.

Crisaborole ointment, 2%, is a nonsteroidal topical phosphodiesterase 4 inhibitor approved for treating mild-to-moderate atopic dermatitis. However, its efficacy and safety in stasis dermatitis (SD) remain unexplored. For a randomized, double-blind, vehicle-controlled, decentralized phase 2a study, researchers sought to assess crisaborole’s efficacy and safety in SD.

About 65 participants aged ≥45 with SD without active ulceration were randomized to receive crisaborole or vehicle (1:1) twice daily for 6 weeks. The primary endpoint was the percentage change from baseline in total sign score at week 6, assessed through in-person evaluations.

Crisaborole-treated participants exhibited significantly reduced total sign scores from baseline compared to the vehicle group, as assessed by both nondermatologist in-person (−32.4% vs. −18.1%, P = .0299) and dermatologist central reader evaluations of photographs (−52.5% vs. −10.3%, P = .0004). Efficacy based on the Investigator’s Global Assessment score and lesional percentage body surface area showed statistical significance in central reader assessments but not in-person evaluations. Common all-causality treatment-emergent adverse events with crisaborole included skin and subcutaneous tissue disorders.

Crisaborole demonstrated improvements in SD signs and symptoms and was well tolerated. Central reader assessment presents a promising approach for siteless clinical research.

Reference: jaad.org/article/S0190-9622(24)00052-5/fulltext