Spotlight on brimonidine topical gel 0.33% for facial erythema of rosacea: safety, efficacy, and patient acceptability

Figures & data

Table 1 Safety of brimonidine topical gel for facial erythema of rosacea

PMID	References	Patient characteristics	Number of subjects	Intervention	Study design	Outcome measure	Results
27272086	Lowe and Lim^Citation25	– 41-year-old Caucasian female – ETR	1	0.33% brimonidine gel BID, metronidazole gel 1% nightly	Case report	Facial erythema	Effective blanching for 2 years followed by delayed paradoxical reaction with increased erythema and rash
26768997	Cookson et al^Citation26	– 24-year-old female –Rosaceal erythema	1	0.33% brimonidine gel once daily	Case report	AEs	Developed facial dermatitis after 6 months use. Patch testing was positive for brimonidine
24742853	Ilkovitch and Pomerantz^Citation27	– 29-year-old female – ETR	1	0.33% brimonidine gel once daily	Case report	Facial erythema	Effective blanching for 12 hours after application followed by rebound erythema worse than baseline lasting 12 hours
24438976	Routt and Levitt^Citation28	– 26-, 38-, and 41-year–old females – Rosaceal erythema	3	0.33% brimonidine gel once daily	Case report	Facial erythema	Erythema reduction for 1–6 hours after application followed by erythema and burning worse than baseline self-resolving >12 hours
25219708	Swanson and Warshaw^Citation29	– 75-year-old female – Rosaceal erythema	1	0.33% brimonidine gel once daily	Case report	AEs	Facial dermatitis days after beginning brimonidine gel. Patch test positive to brimonidine gel and eye drops confirming contact dermatitis to active ingredient
22050040	Fowler et al^Citation22	Studies A and B: – Age ≥18 years – Rosacea, moderate-to-severe erythema	A: 122 B: 269	A: BT 0.5%, 0.18%, 0.07% or vehicle once B: BT 0.5% once daily, 0.18% once daily, 0.18% twice daily, vehicle gel once daily, vehicle gel twice daily	Randomized, double-blind, vehicle controlled	CEA and PSA of erythema, AEs	A: AEs were similarly low across all treatment doses. The most common were irritation, erythema, burning sensation, and pruritus B: AEs were similarly low across all treatment doses. Vehicle gel twice daily had lower AE rate
23839181	Fowler et al^Citation23	– Age ≥18 years – Rosacea, moderate-to-severe erythema – Less than three facial inflammatory lesions	A: 260 B: 293	A and B: BT gel 0.5% vs vehicle gel once daily for 4 weeks with 4-week follow-up	Multicenter, randomized, double-blind, parallel-group, vehicle controlled	CEA and PSA of erythema, telangiectasia using 5-point scale, IGA of lesion severity, AEs	A: AE incidence 29.5% in BT group and 25.2% in vehicle group. Related AE incidence of 11.6% and 0.5%, respectively B: AE incidence of 33.8% in BT group and 24.1% in vehicle group. Related AE incidence of 9.5% and 9.7%, respectively
24385120	Moore et al^Citation24	– Age ≥18 years – Rosacea, moderate-to- evere erythema – No limit on inflammatory lesions present	449	BT gel 0.5% once daily for 1 year	Multicenter, open-label	CEA and PSA of erythema, telangiectasia using 5-point scale, AEs	AEs highest at months 1–3 (41.9% with at least one AE, 21.4% with at least one related AE) and decreases during treatment to 19.5% and 4.2%, respectively, for months 10–12 Concomitant use of other rosacea or acne therapies was not associated with increased AEs Most common AEs: flushing (9.1%), worsening erythema (6.5%), worsening rosacea (3.6%), skin burning (3.3%), skin irritation (3.1%), contact dermatitis (2.2%), and pruritus (2%)

Note: Clinical studies and case series evaluating the safety of brimonidine topical gel for facial erythema of rosacea.

Abbreviations: ETR, erythematotelangiectatic rosacea; AEs, adverse events; BT, brimonidine tartrate; CEA, Clinician’s Erythema Assessment; PSA, Patient Self-Assessment; IGA, Investigator Global Assessment.

Table 2 Efficacy of brimonidine topical gel for facial erythema of rosacea

PMID	References	Patient characteristics	Number of subjects	Intervention	Study design	Outcome measure	Results
22050040	Fowler et al^Citation22	Studies A and B: – Age ≥18 years – Rosacea, moderate-to-severe erythema	A: 122 B: 269	A: BT 0.5%, 0.18%, 0.07% or vehicle once B: BT 0.5% once daily, 0.18% once daily, 0.18% twice daily, vehicle gel once daily, vehicle gel twice daily	Randomized, double-blind, vehicle controlled	CEA and PSA of erythema	A: Reduced facial erythema after single application of BT in a dose-dependent fashion B: 0.5% BT once daily had significant improvement in erythema compared to vehicle on days 1, 15, and 29
23839181	Fowler et al^Citation23	– Age ≥18 years – Rosacea, moderate-to-severe erythema – Less than three facial inflammatory lesions	A: 260 B: 293	A and B: BT gel 0.5% vs vehicle gel once daily for 4 weeks with 4-week follow-up	Multicenter, randomized, double-blind, parallel-group, vehicle controlled	CEA and PSA of erythema, telangiectasia using 5-point scale, IGA of lesion severity, adverse events	Studies A and B both demonstrated that BT gel has greater efficacy compared to vehicle across all measures. Maximum effect was observed from 3 to 6 hours after application
24385120	Moore et al^Citation24	– Age ≥18 years – Rosacea, moderate-to-severe erythema – No limit on inflammatory lesions present	449	BT gel 0.5% once daily for 1 year	Multicenter, open-label	CEA and PSA of erythema, telangiectasia using 5-point scale, adverse events	CEA score improvement seen at hour 3 after each administration. Baseline CEA prior to BT gel administration also improved by month 3 and stayed stable until month 12. No evidence of tachyphylaxis
24918560	Jackson et al^Citation30	– Age ≥18 years – Moderate-to-severe erythema – Less than three facial inflammatory lesions	A: 260 B: 293	A and B: BT gel 0.5% vs vehicle gel once daily for 4 weeks with 4-week follow-up	Subanalysis of previous multicenter, randomized, double-blind, parallel-group, vehicle controlled	CEA and PSA of erythema	Significantly higher percentage of subjects with 1-grade improvement in CEA and PSA after 30 minutes for BT gel vs vehicle group on day 1 (A: 27.9% vs 6.9%; B: 28.4% vs 4.8%), day 15 (A: 55.9% vs 21.1%; B: 45.5% vs 28.4%), and day 29 (A: 58.3% vs 32%; B: 53.5% vs 34.5%)

Note: Clinical studies and case series evaluating the efficacy of brimonidine topical gel for facial erythema of rosacea.

Abbreviations: BT, brimonidine tartrate; CEA, Clinician’s Erythema Assessment; PSA, Patient Self-Assessment; IGA, Investigator Global Assessment.

Table 3 Patient acceptability of brimonidine topical gel for facial erythema of rosacea

PMID	References	Patient characteristics	Number of subjects	Intervention	Study design	Outcome measure	Results
26416164	Layton et al^Citation31	– Average age 54.5 years (25–74 years) – Self-perceived severe facial erythema	92	1 g 0.33% brimonidine gel once daily vs 1 g vehicle gel once daily for 8 days	Randomized, double-blind, vehicle-controlled, parallel group	Patient-reported outcomes via facial redness questionnaire, subject satisfaction questionnaire, and a patient diary of facial redness control	Improved satisfaction of facial appearance (36.9% vs 21.5%), overall treatment effect (69.6% vs 40.4%), facial redness (67.4% vs 33.3%) in BT vs vehicle control
23839181	Fowler et al^Citation23	– Age ≥18 years – Rosacea, moderate-to-severe erythema – Less than three facial inflammatory lesions	A: 260 B: 293	A and B: BT gel 0.5% vs vehicle gel once daily for 4 weeks with 4-week follow-up	Multicenter, randomized, double-blind, parallel-group, vehicle controlled	CEA and PSA of erythema, telangiectasia using 5-point scale, IGA of lesion severity, adverse events	A and B both with significantly higher percentage of patients with 2-grade improvement on CEA and PSA over 12 hours in BT group. Maximum effect was observed from 3 to 6 hours after application
24385120	Moore et al^Citation24	– Age ≥18 years – Rosacea, moderate-to-severe erythema – No limit on inflammatory lesions present	449	BT gel 0.5% once daily for 1 year	Multicenter, open label	CEA and PSA of erythema, telangiectasia using 5-point scale, adverse events	PSA score at hour 0 decreased from day 1 to month 3 and then stable (3.1–2.3) PSA decreased from hour 0 to hour 3 after administration (3.1–2.1). Similar results maintained for all 12 months
24918560	Jackson et al^Citation30	– Age ≥18 years – Rosacea, moderate-to-severe erythema – Less than three facial inflammatory lesions	A: 260 B: 293	A and B: BT gel 0.5% vs vehicle gel once daily for 4 weeks with 4-week follow-up	Subanalysis of previous multicenter, randomized, double-blind, parallel-group, vehicle controlled	CEA and PSA of erythema	Significantly higher percentage of subjects with 1-grade improvement was found on both CEA and PSA after 30 minutes for BT gel vs vehicle group on day 1 (A: 27.9% vs 6.9%; B: 28.4% vs 4.8%), day 15 (A: 55.9% vs 21.1%; B: 45.5% vs 28.4%), and day 29 (A: 58.3% vs 32%; B: 53.5% vs 34.5%)

Note: Clinical studies and case series evaluating the patient acceptability of brimonidine topical gel for facial erythema of rosacea.

Abbreviations: BT, brimonidine tartrate; CEA, Clinician’s Erythema Assessment; PSA, Patient Self-Assessment; IGA, Investigator Global Assessment.

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