Long-term Efficacy and Safety of Microencapsulated Benzoyl Peroxide Cream, 5%, in Rosacea: Results From an Extension of Two Phase III, Vehicle-controlled Trials
Recommended Citation
Werschler WP, Sugarman J, Bhatia N, Baldwin H, Green LJ, Nov O, Ram V, Levy-Hacham O, and Stein Gold L. Long-term Efficacy and Safety of Microencapsulated Benzoyl Peroxide Cream, 5%, in Rosacea: Results From an Extension of Two Phase III, Vehicle-controlled Trials. J Clin Aesthet Dermatol 2023; 16(8):27-33.
Document Type
Article
Publication Date
8-1-2023
Publication Title
J Clin Aesthet Dermatol
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.
PubMed ID
37636251
Volume
16
Issue
8
First Page
27
Last Page
33