Tags

Type your tag names separated by a space and hit enter

Brimonidine gel 0.33% rapidly improves patient-reported outcomes by controlling facial erythema of rosacea: a randomized, double-blind, vehicle-controlled study.
J Eur Acad Dermatol Venereol. 2015 Dec; 29(12):2405-10.JE

Abstract

BACKGROUND

Facial redness contributes to impaired psychosocial functioning in rosacea patients and the only approved treatment for erythema is topical brimonidine gel 0.33%.

OBJECTIVES

To evaluate patient-reported outcomes, as well as efficacy and safety, in subjects with self-perceived severe erythema treated with brimonidine gel 0.33% compared to vehicle.

METHODS

An 8-day multicenter, randomized study comparing once-daily brimonidine gel 0.33% with vehicle gel using a facial redness questionnaire, subject satisfaction questionnaire and a patient diary of facial redness control to assess patient-reported outcomes.

RESULTS

Of the 92 included subjects with self-perceived severe erythema, very few were satisfied with their appearance at baseline (4.2% brimonidine group, 0 vehicle group). On Day 8, significantly more brimonidine group subjects were satisfied with their facial appearance compared to vehicle group (36.9% vs. 21.5%; P < 0.05), with the overall treatment effect (69.6% vs. 40.4%; P < 0.01), and with the improvement in their facial redness (67.4% vs. 33.3%; P < 0.001). More brimonidine group subjects were able to control their facial redness daily (e.g. 83.0% vs. 38.9% on Day 1). On Day 8, significantly more brimonidine group subjects than vehicle group had at least a one-grade improvement from baseline in the Clinician Erythema Assessment score (71.7% vs. 35.7%; P = 0.0011) and Patient Self-Assessment score (76.1% vs. 47.6%; P = 0.004). More subjects in the brimonidine group (29.2%) reported treatment-related adverse events than in the vehicle group (15.9%) but most were mild and transient.

CONCLUSIONS

Once-daily brimonidine gel 0.33% allowed patients to rapidly control their facial redness and significantly improved patient-reported outcomes in the treatment of persistent facial erythema of rosacea.

Links

PMC Free PDF

Authors+Show Affiliations

Layton AM
Harrogate and District NHS Foundation Trust, Harrogate, UK.
Schaller M
Department of Dermatology, Tübingen University Hospital, Tübingen, Germany.
Homey B
Department of Dermatology, Medical Faculty, University of Düsseldorf, Düsseldorf, Germany.
Hofmann MA
Department of Dermatology, Venerology and Allergology, Charité Medical School, Berlin, Germany.
Bewley AP
Whipps Cross University Hospital and the Royal London Hospital, London, UK.
Lehmann P
Center for Dermatology, Allergology, and Surgical Dermatology, Helios Clinic Wuppertal, Wuppertal, Germany.
Nohlgård C
Läkarhuset Odenplan, Stockholm, Sweden.
Sarwer DB
Departments of Psychiatry and Surgery, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.
Kerrouche N
Galderma R&D SNC, Sophia Antipolis, France.
Ma YM
Galderma R&D SNC, Sophia Antipolis, France.

MeSH

Adrenergic alpha-2 Receptor AgonistsAdultAgedBrimonidine TartrateErythemaFacial DermatosesFemaleGelsHumansMaleMiddle AgedPatient SatisfactionRosaceaSeverity of Illness IndexSurveys and QuestionnairesTreatment OutcomeYoung Adult

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26416154

Clinical Trial Links

Clinical trial which this article describes

Citation

Layton, A M., et al. "Brimonidine Gel 0.33% Rapidly Improves Patient-reported Outcomes By Controlling Facial Erythema of Rosacea: a Randomized, Double-blind, Vehicle-controlled Study." Journal of the European Academy of Dermatology and Venereology : JEADV, vol. 29, no. 12, 2015, pp. 2405-10.
Layton AM, Schaller M, Homey B, et al. Brimonidine gel 0.33% rapidly improves patient-reported outcomes by controlling facial erythema of rosacea: a randomized, double-blind, vehicle-controlled study. J Eur Acad Dermatol Venereol. 2015;29(12):2405-10.
Layton, A. M., Schaller, M., Homey, B., Hofmann, M. A., Bewley, A. P., Lehmann, P., Nohlgård, C., Sarwer, D. B., Kerrouche, N., & Ma, Y. M. (2015). Brimonidine gel 0.33% rapidly improves patient-reported outcomes by controlling facial erythema of rosacea: a randomized, double-blind, vehicle-controlled study. Journal of the European Academy of Dermatology and Venereology : JEADV, 29(12), 2405-10. https://doi.org/10.1111/jdv.13305
Layton AM, et al. Brimonidine Gel 0.33% Rapidly Improves Patient-reported Outcomes By Controlling Facial Erythema of Rosacea: a Randomized, Double-blind, Vehicle-controlled Study. J Eur Acad Dermatol Venereol. 2015;29(12):2405-10. PubMed PMID: 26416154.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Brimonidine gel 0.33% rapidly improves patient-reported outcomes by controlling facial erythema of rosacea: a randomized, double-blind, vehicle-controlled study. AU - Layton,A M, AU - Schaller,M, AU - Homey,B, AU - Hofmann,M A, AU - Bewley,A P, AU - Lehmann,P, AU - Nohlgård,C, AU - Sarwer,D B, AU - Kerrouche,N, AU - Ma,Y M, Y1 - 2015/09/28/ PY - 2015/04/27/received PY - 2015/06/05/accepted PY - 2015/9/30/entrez PY - 2015/9/30/pubmed PY - 2016/10/16/medline SP - 2405 EP - 10 JF - Journal of the European Academy of Dermatology and Venereology : JEADV JO - J Eur Acad Dermatol Venereol VL - 29 IS - 12 N2 - BACKGROUND: Facial redness contributes to impaired psychosocial functioning in rosacea patients and the only approved treatment for erythema is topical brimonidine gel 0.33%. OBJECTIVES: To evaluate patient-reported outcomes, as well as efficacy and safety, in subjects with self-perceived severe erythema treated with brimonidine gel 0.33% compared to vehicle. METHODS: An 8-day multicenter, randomized study comparing once-daily brimonidine gel 0.33% with vehicle gel using a facial redness questionnaire, subject satisfaction questionnaire and a patient diary of facial redness control to assess patient-reported outcomes. RESULTS: Of the 92 included subjects with self-perceived severe erythema, very few were satisfied with their appearance at baseline (4.2% brimonidine group, 0 vehicle group). On Day 8, significantly more brimonidine group subjects were satisfied with their facial appearance compared to vehicle group (36.9% vs. 21.5%; P < 0.05), with the overall treatment effect (69.6% vs. 40.4%; P < 0.01), and with the improvement in their facial redness (67.4% vs. 33.3%; P < 0.001). More brimonidine group subjects were able to control their facial redness daily (e.g. 83.0% vs. 38.9% on Day 1). On Day 8, significantly more brimonidine group subjects than vehicle group had at least a one-grade improvement from baseline in the Clinician Erythema Assessment score (71.7% vs. 35.7%; P = 0.0011) and Patient Self-Assessment score (76.1% vs. 47.6%; P = 0.004). More subjects in the brimonidine group (29.2%) reported treatment-related adverse events than in the vehicle group (15.9%) but most were mild and transient. CONCLUSIONS: Once-daily brimonidine gel 0.33% allowed patients to rapidly control their facial redness and significantly improved patient-reported outcomes in the treatment of persistent facial erythema of rosacea. SN - 1468-3083 UR - https://www.unboundmedicine.com/medline/citation/26416154/Brimonidine_gel_0_33_rapidly_improves_patient_reported_outcomes_by_controlling_facial_erythema_of_rosacea:_a_randomized_double_blind_vehicle_controlled_study_ DB - PRIME DP - Unbound Medicine ER -