Novel Rosacea Gel Scores in Phase III Trial

PRAGUE – Once-daily brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea hit its efficacy and safety end points in a pivotal phase III clinical trial.

The randomized, double-blind, vehicle-controlled, multicenter study totaled 260 patients with persistent moderate to severe facial redness from rosacea. The patients were randomized to once-daily brimonidine tartrate gel 0.5% or a vehicle gel for 4 weeks, with 4 weeks of subsequent off-label follow-up.

The proprietary brimonidine tartrate gel proved faster acting and significantly more effective than the vehicle. Thirty minutes after the first application on study day 1, 28% of patients in the active treatment arm showed at least a 1-grade improvement on both Patient Self-Assessment and Clinician’s Erythema Assessment, compared with 7% of controls, Dr. Y. May Ma reported at the annual congress of the European Academy of Dermatology and Venereology.

The other efficacy end point was maintenance of a 2-grade improvement on both study measures for 12 hours after application on day 29. This was achieved in 23% of patients in the brimonidine tartrate gel cohort and 8% of controls.

No tachyphylaxis or rebound worsening of erythema occurred during the off-treatment follow-up, nor did the brimonidine tartrate group experience aggravation of telangiectasias or inflammatory lesions during that phase of the study, according to Dr. Ma of Galderma Laboratories, Sophia Antipolis, France.

The adverse events were generally mild, transient, and local. The most frequent events in the brimonidine tartrate group were worsening erythema and/or flushing in seven patients, itching in four, and skin irritation in three. No changes in blood pressure or heart rate were noted.

At present no medical therapies are approved for the treatment of persistent facial redness of rosacea. While brimonidine tartrate gel doesn’t tackle the underlying cause of rosacea, the topical vasoconstrictor does improve the appearance of rosacea patients who have persistent erythema. Galderma is preparing to file for U.S. and European marketing approval of the topical agent.

The trial was sponsored by Galderma Laboratories and presented by Dr. Ma, a company employee.

PRAGUE – Once-daily brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea hit its efficacy and safety end points in a pivotal phase III clinical trial.

The randomized, double-blind, vehicle-controlled, multicenter study totaled 260 patients with persistent moderate to severe facial redness from rosacea. The patients were randomized to once-daily brimonidine tartrate gel 0.5% or a vehicle gel for 4 weeks, with 4 weeks of subsequent off-label follow-up.

The proprietary brimonidine tartrate gel proved faster acting and significantly more effective than the vehicle. Thirty minutes after the first application on study day 1, 28% of patients in the active treatment arm showed at least a 1-grade improvement on both Patient Self-Assessment and Clinician’s Erythema Assessment, compared with 7% of controls, Dr. Y. May Ma reported at the annual congress of the European Academy of Dermatology and Venereology.

The other efficacy end point was maintenance of a 2-grade improvement on both study measures for 12 hours after application on day 29. This was achieved in 23% of patients in the brimonidine tartrate gel cohort and 8% of controls.

No tachyphylaxis or rebound worsening of erythema occurred during the off-treatment follow-up, nor did the brimonidine tartrate group experience aggravation of telangiectasias or inflammatory lesions during that phase of the study, according to Dr. Ma of Galderma Laboratories, Sophia Antipolis, France.

The adverse events were generally mild, transient, and local. The most frequent events in the brimonidine tartrate group were worsening erythema and/or flushing in seven patients, itching in four, and skin irritation in three. No changes in blood pressure or heart rate were noted.

At present no medical therapies are approved for the treatment of persistent facial redness of rosacea. While brimonidine tartrate gel doesn’t tackle the underlying cause of rosacea, the topical vasoconstrictor does improve the appearance of rosacea patients who have persistent erythema. Galderma is preparing to file for U.S. and European marketing approval of the topical agent.

The trial was sponsored by Galderma Laboratories and presented by Dr. Ma, a company employee.

PRAGUE – Once-daily brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea hit its efficacy and safety end points in a pivotal phase III clinical trial.

The randomized, double-blind, vehicle-controlled, multicenter study totaled 260 patients with persistent moderate to severe facial redness from rosacea. The patients were randomized to once-daily brimonidine tartrate gel 0.5% or a vehicle gel for 4 weeks, with 4 weeks of subsequent off-label follow-up.

The proprietary brimonidine tartrate gel proved faster acting and significantly more effective than the vehicle. Thirty minutes after the first application on study day 1, 28% of patients in the active treatment arm showed at least a 1-grade improvement on both Patient Self-Assessment and Clinician’s Erythema Assessment, compared with 7% of controls, Dr. Y. May Ma reported at the annual congress of the European Academy of Dermatology and Venereology.

The other efficacy end point was maintenance of a 2-grade improvement on both study measures for 12 hours after application on day 29. This was achieved in 23% of patients in the brimonidine tartrate gel cohort and 8% of controls.

No tachyphylaxis or rebound worsening of erythema occurred during the off-treatment follow-up, nor did the brimonidine tartrate group experience aggravation of telangiectasias or inflammatory lesions during that phase of the study, according to Dr. Ma of Galderma Laboratories, Sophia Antipolis, France.

The adverse events were generally mild, transient, and local. The most frequent events in the brimonidine tartrate group were worsening erythema and/or flushing in seven patients, itching in four, and skin irritation in three. No changes in blood pressure or heart rate were noted.

At present no medical therapies are approved for the treatment of persistent facial redness of rosacea. While brimonidine tartrate gel doesn’t tackle the underlying cause of rosacea, the topical vasoconstrictor does improve the appearance of rosacea patients who have persistent erythema. Galderma is preparing to file for U.S. and European marketing approval of the topical agent.

The trial was sponsored by Galderma Laboratories and presented by Dr. Ma, a company employee.