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Long-term safety and efficacy of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea: results of a 1-year open-label study.
J Drugs Dermatol. 2014 Jan; 13(1):56-61.JD

Abstract

Once-daily topical brimonidine tartrate (BT) gel 0.5% was shown to be efficacious and safe for the treatment of erythema of rosacea in previous studies including a 4-week treatment phase. In the present 1-year study, we aimed to assess the long-term safety and efficacy of the treatment. Subjects with moderate to severe erythema of rosacea were instructed to apply topical BT gel 0.5% once daily for 12 months. Severity of erythema and adverse events (AEs) were evaluated. Approximately 345 subject years of exposure to BT gel 0.5% was achieved in the study. The incidence of AEs and AEs judged to be related to the study drug was higher at the beginning and decreased over the course of the study. Similar safety profiles were observed between the subjects who had received or not received concomitant therapies for the inflammatory lesions of rosacea. Effect of topical BT gel 0.5% on erythema severity was observed after the first application and the durability of the effect was maintained until the end of the study at month 12, with no tachyphylaxis observed. In conclusion, once-daily topical BT gel 0.5% is safe and consistently effective for the long-term treatment of moderate to severe erythema of rosacea, even in the presence of concomitant therapies for the inflammatory lesions of rosacea.

Authors

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Pub Type(s)

Clinical Trial
Journal Article

Language

eng

PubMed ID

24385120

Citation

Moore, Angela, et al. "Long-term Safety and Efficacy of Once-daily Topical Brimonidine Tartrate Gel 0.5% for the Treatment of Moderate to Severe Facial Erythema of Rosacea: Results of a 1-year Open-label Study." Journal of Drugs in Dermatology : JDD, vol. 13, no. 1, 2014, pp. 56-61.
Moore A, Kempers S, Murakawa G, et al. Long-term safety and efficacy of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea: results of a 1-year open-label study. J Drugs Dermatol. 2014;13(1):56-61.
Moore, A., Kempers, S., Murakawa, G., Weiss, J., Tauscher, A., Swinyer, L., Liu, H., & Leoni, M. (2014). Long-term safety and efficacy of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea: results of a 1-year open-label study. Journal of Drugs in Dermatology : JDD, 13(1), 56-61.
Moore A, et al. Long-term Safety and Efficacy of Once-daily Topical Brimonidine Tartrate Gel 0.5% for the Treatment of Moderate to Severe Facial Erythema of Rosacea: Results of a 1-year Open-label Study. J Drugs Dermatol. 2014;13(1):56-61. PubMed PMID: 24385120.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term safety and efficacy of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea: results of a 1-year open-label study. AU - Moore,Angela, AU - Kempers,Steven, AU - Murakawa,George, AU - Weiss,Jonathan, AU - Tauscher,Amanda, AU - Swinyer,Leonard, AU - Liu,Hong, AU - Leoni,Matthew, PY - 2014/1/4/entrez PY - 2014/1/5/pubmed PY - 2014/8/29/medline SP - 56 EP - 61 JF - Journal of drugs in dermatology : JDD JO - J Drugs Dermatol VL - 13 IS - 1 N2 - Once-daily topical brimonidine tartrate (BT) gel 0.5% was shown to be efficacious and safe for the treatment of erythema of rosacea in previous studies including a 4-week treatment phase. In the present 1-year study, we aimed to assess the long-term safety and efficacy of the treatment. Subjects with moderate to severe erythema of rosacea were instructed to apply topical BT gel 0.5% once daily for 12 months. Severity of erythema and adverse events (AEs) were evaluated. Approximately 345 subject years of exposure to BT gel 0.5% was achieved in the study. The incidence of AEs and AEs judged to be related to the study drug was higher at the beginning and decreased over the course of the study. Similar safety profiles were observed between the subjects who had received or not received concomitant therapies for the inflammatory lesions of rosacea. Effect of topical BT gel 0.5% on erythema severity was observed after the first application and the durability of the effect was maintained until the end of the study at month 12, with no tachyphylaxis observed. In conclusion, once-daily topical BT gel 0.5% is safe and consistently effective for the long-term treatment of moderate to severe erythema of rosacea, even in the presence of concomitant therapies for the inflammatory lesions of rosacea. SN - 1545-9616 UR - https://www.unboundmedicine.com/medline/citation/24385120/Long_term_safety_and_efficacy_of_once_daily_topical_brimonidine_tartrate_gel_0_5_for_the_treatment_of_moderate_to_severe_facial_erythema_of_rosacea:_results_of_a_1_year_open_label_study_ DB - PRIME DP - Unbound Medicine ER -