52573
document
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 . BACKGROUND Erythema of rosacea is thought to result from abnormal cutaneous vasomotor activity . Brimonidine tartrate ( BT ) is a highly selective α ( 2 ) -adrenergic receptor agonist with vasoconstrictive activity . OBJECTIVE To determine the optimal concentration and dose regimen of topical BT gel for the treatment of erythema of rosacea and to evaluate its efficacy and safety . METHODS In study A , 122 subjects were randomized to receive a single application of BT 0·07 % , 0·18 % , 0·5 % or vehicle . In study B ( 4-week treatment and 4-week follow-up ) , 269 subjects were randomized to receive BT 0·5 % once daily , BT 0·18 % once daily , vehicle once daily , BT 0·18 % twice daily or vehicle twice daily . Evaluations included Clinician 's Erythema Assessment ( CEA ) , Patient 's Self-Assessment ( PSA ) , Chroma Meter measurements and adverse events . RESULTS In study A , a single application of topical BT gel reduced facial erythema in a dose-dependent fashion . A significant difference between BT 0·5 % and vehicle in Chroma Meter redness value was observed from 30min to 12h after application . In study B , BT 0·5 % once daily had a statistically superior success profile ( defined as a two-grade improvement on both CEA and PSA over 12h ) compared with vehicle once daily on days 1 , 15 and 29 ( all P < 0·001 ) . No tachyphylaxis , rebound of erythema or aggravation of other disease signs ( telangiectasia , inflammatory lesions ) was observed . All regimens were safe and well tolerated with similarly low incidence of adverse events . CONCLUSIONS Once-daily BT gel 0·5 % is well tolerated and provides significantly greater efficacy than vehicle gel for the treatment of moderate to severe erythema of rosacea .
52574
Intervention_Pharmacological
topical brimonidine tartrate gel
52575
Outcome_Physical
of erythema of rosacea
52576
Outcome_Other
its efficacy and safety
52577
Outcome_Physical
included Clinician 's Erythema Assessment ( CEA )
52578
Outcome_Physical
Patient 's Self-Assessment ( PSA
52579
Outcome_Physical
Chroma Meter measurements
52580
Outcome_Adverse-effects
adverse
52581
Outcome_Physical
topical BT gel reduced facial erythema
52582
Outcome_Physical
vehicle in Chroma Meter redness
52583
Outcome_Other
statistically superior success
52584
Outcome_Physical
two-grade improvement on both CEA
52585
Outcome_Physical
No tachyphylaxis , rebound of erythema or aggravation of other disease signs ( telangiectasia , inflammatory
52586
Outcome_Other
regimens were safe and well
52587
Outcome_Adverse-effects
incidence of adverse
52588
Outcome_Other
significantly greater
52589
Participant_Condition
Erythema of rosacea
52590
Participant_Sample-size
122 subjects
52591
Participant_Sample-size
269 subjects