Funding sources The two studies were funded by Galderma R&D.
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
Article first published online: 22 FEB 2012
© 2011 The Authors. BJD © 2011 British Association of Dermatologists
British Journal of Dermatology
Volume 166, Issue 3, pages 633–641, March 2012
How to Cite
Fowler, J., Jarratt, M., Moore, A., Meadows, K., Pollack, A., Steinhoff, M., Liu, Y., Leoni, M. and on behalf of the Brimonidine Phase II Study Group (2012), 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, 166: 633–641. doi: 10.1111/j.1365-2133.2011.10716.x
Conflicts of interest The investigators received grants for conducting the studies. Y.L. and M.L. are employees of Galderma R&D.
ClinicalTrials.gov registration numbers: NCT00989014, NCT01174030.
- Issue published online: 22 FEB 2012
- Article first published online: 22 FEB 2012
- Accepted manuscript online: 2 NOV 2011 12:11PM EST
- Accepted for publication 26 October 2011
Background Erythema of rosacea is thought to result from abnormal cutaneous vasomotor activity. Brimonidine tartrate (BT) is a highly selective α2-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 30 min to 12 h 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 12 h) 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.