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

Authors

Jonathan I. Silverberg, Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC. Electronic address: jonathanisilverberg@gmail.com.
Robert S. Kirsner, Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, Florida.
David J. Margolis, Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Michael Tharp, TrueBlue Clinical Research, Tampa, Florida.
Daniela E. Myers, Pfizer Inc., Collegeville, Pennsylvania.
Karen Annis, Pfizer Inc., New York, New York.
Daniela Graham, Pfizer Inc., Groton, Connecticut.
Chuanbo Zang, Pfizer Inc., Collegeville, Pennsylvania.
Bonnie L. Vlahos, Pfizer Inc., Collegeville, Pennsylvania.
Paul Sanders, Pfizer R&D UK Ltd., Tadworth, Surrey, United Kingdom.

Document Type

Journal Article

Publication Date

2-7-2024

Journal

Journal of the American Academy of Dermatology

DOI

10.1016/j.jaad.2023.12.048

Keywords

chronic venous insufficiency; crisaborole; decentralized study; phosphodiesterase-4 inhibitor; pruritus; stasis dermatitis; topical ointment; total sign score

Abstract

BACKGROUND: Crisaborole ointment, 2%, is a nonsteroidal topical phosphodiesterase 4 inhibitor approved for the treatment of mild-to-moderate atopic dermatitis. OBJECTIVE: To evaluate the efficacy and safety of crisaborole in stasis dermatitis (SD). METHODS: 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. LIMITATIONS: Small sample size and short treatment duration were key limitations. In-person assessment was not conducted by dermatologists. CONCLUSION: Crisaborole improved signs and symptoms of SD and was well tolerated. Central reader assessment represents a promising approach for siteless clinical research.

APA Citation

Silverberg, Jonathan I.; Kirsner, Robert S.; Margolis, David J.; Tharp, Michael; Myers, Daniela E.; Annis, Karen; Graham, Daniela; Zang, Chuanbo; Vlahos, Bonnie L.; and Sanders, Paul, "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" (2024). GW Authored Works. Paper 4376.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/4376

Department

Dermatology