Crisaborole may significantly improve stasis dermatitis, finds innovative study

Crisaborole ointment, 2%, is a nonsteroidal topical phosphodiesterase 4 inhibitor approved for the treatment of mild-to-moderate atopic dermatitis. A study was done to evaluate the efficacy and safety of crisaborole in stasis dermatitis (SD). In this randomized, double-blind, vehicle-controlled, decentralized phase 2a study (NCT04091087), 65 participants aged ≥45 years with SD without active ulceration received crisaborole or vehicle (1:1) twice-daily for 6 weeks. The primary end point was percentage change from baseline in total sign score at week 6 based on in-person assessment.

Results: Crisaborole-treated participants had significantly reduced total sign score from baseline versus vehicle based on in-person (nondermatologist) assessment (−32.4% vs −18.1%, P = .0299) and central reader (dermatologists) assessment of photographs (−52.5% vs −10.3%, P = .0004). Efficacy according to success and improvement per Investigator's Global Assessment score and lesional percentage body surface area reached statistical significance based on central reader but not in-person assessments. Skin and subcutaneous tissue disorders were common all-causality treatment-emergent adverse events with crisaborole. Small sample size and short treatment duration were key limitations. In-person assessment was not conducted by dermatologists. Crisaborole improved signs and symptoms of SD and was well tolerated. Central reader assessment represents a promising approach for siteless clinical research.

Reference:

Jonathan I. Silverberg, Robert S. Kirsner, David J. Margolis, Michael Tharp, Daniela E. Myers, Karen Annis, Daniela Graham, Chuanbo Zang, Bonnie L. Vlahos, Paul Sanders,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,Journal of the American Academy of Dermatology,2024, ISSN 0190-9622. https://doi.org/10.1016/j.jaad.2023.12.048.(https://www.sciencedirect.com/science/article/pii/S0190962224000525)

Crisaborole, stasis dermatitis, Jonathan I. Silverberg, Robert S. Kirsner, David J. Margolis, Michael Tharp, Daniela E. Myers, Karen Annis, Daniela Graham, Chuanbo Zang, Bonnie L. Vlahos, Paul Sanders, crisaborole ointment, 2%, chronic venous insufficiency; crisaborole; decentralized study; phosphodiesterase-4 inhibitor; pruritus; stasis dermatitis; topical ointment; total sign score