Dermatological Adverse Events Associated with Topical Brimonidine Gel 0.33% in Subjects with Erythema of Rosacea: A Retrospective Review of Clinical Studies.
BACKGROUND
The topical α2 adrenergic receptor agonist brimonidine gel 0.33% is an effective and safe pharmacological treatment for the facial erythema of rosacea. However, adverse events of worsened redness have occasionally been reported with its use.


OBJECTIVE
A detailed analysis of adverse events is needed to accurately define worsening erythema and the adverse-events profile associated with brimonidine gel treatment.


METHODS
A retrospective review of related dermatological adverse events occurring in subjects enrolled in the two pivotal four-week Phase 3 studies and the 52-week long-term safety study for brimonidine gel was conducted. Measurements included total adverse-event incidences; number of subjects experiencing adverse events; study discontinuation due to adverse events, severity, onset, episodic duration period; and correlation of adverse events to subject disposition, and rosacea profile.


RESULTS
Flushing and erythema were the most commonly reported adverse events, occurring in a total of 5.4 percent of subjects in the Phase 3 studies and in 15.4 percent in the long-term study. Most adverse events were mild or moderate in severity, transient, and intermittent. Adverse events occurred early in treatment, and duration was short-lived in the majority of cases. Adverse-event patterns were not remarkably altered with regard to subject disposition in the long-term study.


CONCLUSIONS
Adverse events of worsening redness are not frequent, are transient in nature, and occur early in the course of treatment with brimonidine gel.
Galderma Laboratories, LP, Fort Worth, Texas;
Anna D
AD
Holmes
Galderma Laboratories, LP, Fort Worth, Texas;
Kimberly A
KA
Waite
Galderma Laboratories, LP, Fort Worth, Texas;
Michael C
MC
Chen
Galderma Laboratories, LP, Fort Worth, Texas;
Kiruthi
K
Palaniswamy
Galderma Laboratories, LP, Fort Worth, Texas;
Thomas H
TH
Wiser
Dermatology Consulting Services, High Point, North Carolina;
Zoe D
ZD
Draelos
DermResearchCenter of New York, Inc., Stony Brook, New York;
Elyse S
ES
Rafal
University of Washington School of Medicine, Seattle, Washington.
W Philip
WP
Werschler
Galderma Laboratories, LP, Fort Worth, Texas;
Alison E
AE
Harvey