Long-term Efficacy and Safety of Microencapsulated Benzoyl Peroxide Cream, 5%, in Rosacea: Results From an Extension of Two Phase III, Vehicle-controlled Trials

Authors

William P. Werschler, Dr. Werschler is with Spokane Dermatology Clinic and Werschler Aesthetics in Spokane, Washington.
Jeffrey Sugarman, Dr. Sugarman is with the University of California San Francisco School of Medicine in San Francisco, California.
Neal Bhatia, Dr. Bhatia is with Therapeutics Clinical Research in San Diego, California.
Hilary Baldwin, Dr. Baldwin is with the Acne Treatment and Research Center in Brooklyn, New York, and Robert Wood Johnson Medical Center in New Brunswick, New Jersey.
Lawrence J. Green, Dr. Green is with the George Washington University School of Medicine in Washington, DC.
Ori Nov, Dr. Nov, Mr. Ram, and Dr. Levy-Hacham are with Sol-Gel Technologies Ltd in Ness Ziona, Israel.
Vered Ram, Dr. Nov, Mr. Ram, and Dr. Levy-Hacham are with Sol-Gel Technologies Ltd in Ness Ziona, Israel.
Ofra Levy-Hacham, Dr. Nov, Mr. Ram, and Dr. Levy-Hacham are with Sol-Gel Technologies Ltd in Ness Ziona, Israel.
Linda Stein Gold, Dr. Stein Gold is with Henry Ford Health in Detroit, Michigan.

Document Type

Journal Article

Publication Date

8-1-2023

Journal

The Journal of clinical and aesthetic dermatology

Volume

16

Issue

8

Keywords

BPO; Rosacea; benzoyl peroxide; erythema; microencapsulation; papulopustular rosacea; topicals

Abstract

OBJECTIVE: We sought to assess the long-term safety and tolerability of microencapsulated benzoyl peroxide cream, 5% (E-BPO cream, 5%), in subjects with rosacea. Efficacy and tolerability have been previously demonstrated in two 12-week, randomized, double-blind, vehicle-controlled Phase III trials. METHODS: In this open-label extension study (NCT03564145; clinicaltrials.gov), all subjects from the initial placebo-controlled Phase III trials could receive E-BPO cream, 5%, for up to an additional 40 weeks, up to a total of 52 weeks of E-BPO cream, 5%, exposure. If a subject was assessed at study visits as "clear" or "almost clear" using the 5-point Investigator Global Assessment (IGA) scale (IGA 0 or 1), E-BPO cream, 5%, was not dispensed. If a subject was assessed as "mild to severe" (IGA 2+), E-BPO cream, 5%, was applied daily until they reached "clear" or "almost clear." RESULTS: The safety and tolerability profile for E-BPO cream, 5%, was similar to that reported in the Phase III studies. Five subjects (0.9%) discontinued study drug due to treatment-related adverse events, and 17 subjects (3.2%) experienced an adverse event considered related to study drug. IGA success after 40 weeks of active treatment was 66.5 percent for subjects continuing from the Phase III vehicle group (n=172) and 67.6 percent for subjects who continued Phase III E-BPO cream, 5% (n=363). The study ended early in accordance with the protocol. LIMITATIONS: Safety and tolerability of E-BPO were not compared with those of unencapsulated BPO. CONCLUSION: E-BPO cream, 5%, showed a favorable safety and tolerability profile during this 40-week, open-label extension study.

APA Citation

Werschler, William P.; Sugarman, Jeffrey; Bhatia, Neal; Baldwin, Hilary; Green, Lawrence J.; Nov, Ori; Ram, Vered; Levy-Hacham, Ofra; and Stein Gold, Linda, "Long-term Efficacy and Safety of Microencapsulated Benzoyl Peroxide Cream, 5%, in Rosacea: Results From an Extension of Two Phase III, Vehicle-controlled Trials" (2023). GW Authored Works. Paper 3294.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/3294

Department

Dermatology