The role of brimonidine tartrate gel in the treatment of rosacea

Figures & data

Table 1 Overview of Phase II and III clinical studies with BT in patients with moderate to severe erythema of rosacea

Study name/Phase	Reference	Sex (male/female)	Patients enrolled (n)	Treatment	Study centers
Phase II study A	Fowler et al^Citation21	30/92	122	One application of BT 0.5%, 0.18%, 0.07%, or vehicle	Five in the United States
Phase II study B	Fowler et al^Citation21	52/217	269	BT 0.5% od/bd, BT 0.18% od/bd, or vehicle od/bd	17 in the United States
Phase III study A	Fowler et al^Citation20	54/206	260	BT 0.5% od, vehicle od	15 in the United States and Canada
Phase III study B	Fowler et al^Citation20	80/213	293	BT 0.5% od, vehicle od	15 in the United States and Canada
1-year study	Moore et al^Citation22	113/336	449	BT 0.5% od	27 in the United States

Abbreviations: BT, brimonidine tartrate; n, number; od, once daily; bd, twice daily

Table 2 CEA and PSA

Scores^Citation21,Citation46	CEA^Citation21	PSA^Citation46
0= clear	Clear skin with no signs of erythema	No redness
1= almost clear	Almost clear; slight redness	Very mild redness
2= mild	Mild erythema; definite redness	Mild redness
3= moderate	Moderate erythema; marked redness	Moderate redness
4= severe	Severe erythema; fiery redness	Severe redness

Notes: Adapted with permission, from: Fowler J, Jarratt M, Moore A, et al; Brimonidine Phase II Study Group. Once-daily topical brimonidine tartrate gel 0·5% is a novel treatment for moderate to severe facial erythema of rosacea: results of two multicentre, randomized and vehicle-controlled studies. British Journal of Dermatology. 2012;166(3):633–641. © 2011 The Authors. BJD © 2011 British Association of Dermatologists.²¹ And adapted with permission, from: Jackson JM, Fowler J, Moore A, et al; Brimonidine Phase III Study Group. Improvement in facial erythema within 30 minutes of initial application of brimonidine tartrate in patients with rosacea. J Drugs Dermatol. 2014;13(6):699–704. Copyright © 2014 Journal of Drugs in Dermatology.⁴⁶

Abbreviations: CEA, clinician’s erythema assessment; PSA, patient’s self-assessment.

Figure 1 Percentage of subjects treated with brimonidine tartrate with improvements on CEA and PSA.

Notes: (A) Percentage of subjects having a two-grade improvement on both CEA and PSA on day 29 (treatment with brimonidine tartrate 0.5% versus vehicle gel); P<0.001 versus vehicle over 12 hours.²⁰ Adapted with permission, from: Fowler J Jr, Jackson M, Moore A, et al. Efficacy and safety of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moder ate to severe facial erythema of rosacea: results of two randomized, double-blind, and vehicle-controlled pivotal studies. J Drugs Dermatol. 2013;12(6):650–656. Copyright © 2013 Journal of Drugs in Dermatology.²⁰ (B) Percentage of subjects having a one-grade improvement on both CEA and PSA in 30 minutes on day 1 (treatment with brimonidine tartrate 0.5% versus vehicle gel); P<0.001 versus vehicle at all time points. Adapted with permission, from: Jackson JM, Fowler J, Moore A, et al; Brimonidine Phase III Study Group. Improvement in facial erythema within 30 minutes of initial application of brimonidine tartrate in patients with rosacea. J Drugs Dermatol. 2014;13(6):699–704.⁴⁶ Copyright © 2014 Journal of Drugs in Dermatology.
Abbreviations: n, number; CEA, clinician’s erythema assessment; PSA, patient’s self-assessment.

Figure 2 Standardized photos of a representative subject before and at 30 minutes, 3 hours, 6 hours, 9 hours, and 12 hours after the application of brimonidine tartrate gel on day 1.

Notes: ✓ One-grade improvement on both CEA and PSA; ✓✓ two-grade improvement on both CEA and PSA.
Abbreviations: CEA, clinician’s erythema assessment; PSA, patient’s self-assessment.

Figure 3 Standardized photos of a representative subject before and at 30 minutes, 3 hours, 6 hours, 9 hours, and 12 hours after the application of brimonidine tartrate gel on day 1.

Notes: ✓ One-grade improvement on both CEA and PSA; ✓✓ two-grade improvement on both CEA and PSA. © 2014 European Academy of Dermatology and Venereology. Publisher: John Wiley and Sons. Reproduced from Fowler J, Tan J, Jackson JM, et al; Brimonidine Phase III Study Group. Treatment of facial erythema in patients with rosacea with topical brimonidine tartrate: correlation of patient satisfaction with standard clinical endpoints of improvement of facial erythema. Journal of the European Academy of Dermatology and Venereology. 2015;29(3):474–481.⁴⁷
Abbreviations: CEA, clinician’s erythema assessment; PSA, patient’s self-assessment.

Table 3 Most commonly reported adverse events considered to be related to the study drug (≥2% patients)

Adverse event	Percentage of patients
Flushing	9.1
Worsening of erythema	6.5
Worsening of rosacea	3.6
Skin burning sensation	3.3
Skin irritation	3.1
Contact dermatitis	2.2
Pruritus	2.0

Notes: The total number of patients reporting adverse events was 139 (31%). Data from Galderma Ltd., study number RD.03.DEU.0485.R00, data on file, 2012; and Tan et al.³

FowlerJJarrattMMooreABrimonidine Phase II Study GroupOnce-daily topical brimonidine tartrate gel 0.5% is a novel treatment for moderate to severe facial erythema of rosacea: results of two multicentre, randomized and vehicle-controlled studiesBr J Dermatol2012166363364122050040

 PubMed Web of Science ®Google Scholar

FowlerJJrJacksonMMooreAEfficacy and safety of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea: results of two randomized, double-blind, and vehicle-controlled pivotal studiesJ Drugs Dermatol201312665065623839181

 PubMed Web of Science ®Google Scholar

MooreAKempersSMurakawaGLong-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 studyJ Drugs Dermatol2014131566124385120

 PubMed Web of Science ®Google Scholar

JacksonJMFowlerJMooreABrimonidine Phase III Study GroupImprovement in facial erythema within 30 minutes of initial application of brimonidine tartrate in patients with rosaceaJ Drugs Dermatol201413669970424918560

 PubMed Web of Science ®Google Scholar

FowlerJTanJJacksonJMBrimonidine Phase III Study GroupTreatment of facial erythema in patients with rosacea with topical brimonidine tartrate: correlation of patient satisfaction with standard clinical endpoints of improvement of facial erythemaJ Eur Acad Dermatol Venereol201529347448125074756

 PubMed Web of Science ®Google Scholar

TanJBlume-PeytaviUOrtonneJPAn observational cross-sectional survey of rosacea: clinical associations and progression between subtypesBr J Dermatol2013169355556223600367

 PubMed Web of Science ®Google Scholar