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Holmes AD, Waite KA, Chen MC, et al. Dermatological Adverse Events Associated with Topical Brimonidine Gel 0.33% in Subjects with Erythema of Rosacea: A Retrospective Review of Clinical Studies. J Clin Aesthet Dermatol. 2015;8(8):29-35
Holmes, A. D., Waite, K. A., Chen, M. C., Palaniswamy, K., Wiser, T. H., Draelos, Z. D., Rafal, E. S., Werschler, W. P., & Harvey, A. E. (2015). Dermatological Adverse Events Associated with Topical Brimonidine Gel 0.33% in Subjects with Erythema of Rosacea: A Retrospective Review of Clinical Studies. The Journal of clinical and aesthetic dermatology, 8(8), 29-35.
Holmes, Anna D, et al. "Dermatological Adverse Events Associated with Topical Brimonidine Gel 0.33% in Subjects with Erythema of Rosacea: A Retrospective Review of Clinical Studies." The Journal of clinical and aesthetic dermatology vol. 8,8 (2015): 29-35.
Holmes AD, Waite KA, Chen MC, Palaniswamy K, Wiser TH, Draelos ZD, Rafal ES, Werschler WP, Harvey AE. Dermatological Adverse Events Associated with Topical Brimonidine Gel 0.33% in Subjects with Erythema of Rosacea: A Retrospective Review of Clinical Studies. J Clin Aesthet Dermatol. 2015 Aug;8(8):29-35. PMID: 26345379; PMCID: PMC4557848.
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J Clin Aesthet Dermatol. 2015 Aug;8(8):29-35.

Dermatological Adverse Events Associated with Topical Brimonidine Gel 0.33% in Subjects with Erythema of Rosacea: A Retrospective Review of Clinical Studies.

The Journal of clinical and aesthetic dermatology

Anna D Holmes, Kimberly A Waite, Michael C Chen, Kiruthi Palaniswamy, Thomas H Wiser, Zoe D Draelos, Elyse S Rafal, W Philip Werschler, Alison E Harvey

Affiliations

  1. Galderma Laboratories, LP, Fort Worth, Texas;
  2. Dermatology Consulting Services, High Point, North Carolina;
  3. DermResearchCenter of New York, Inc., Stony Brook, New York;
  4. University of Washington School of Medicine, Seattle, Washington.

PMID: 26345379 PMCID: PMC4557848

Abstract

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 AND MEASUREMENTS: 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.

CONCLUSION: Adverse events of worsening redness are not frequent, are transient in nature, and occur early in the course of treatment with brimonidine gel.

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