Improvement in facial erythema within 30 minutes of initial application of brimonidine tartrate in patients with rosacea.

BACKGROUND: Brimonidine tartrate (BT) 0.5% gel demonstrated significantly greater efficacy versus vehicle gel once-daily for the treatment of moderate to severe erythema of rosacea. OBJECTIVES: To assess the 30-minute speed of onset of topical BT 0.5% gel in reducing facial erythema in Phase III studies as measured by subject and clinician assessments of erythema. METHODS: Two Phase III, randomized, controlled studies with identical design in which subjects with moderate erythema of rosacea (study A: n=260; study B: n=293) were randomized 1:1 to apply topical BT 0.5% or vehicle gel once-daily for 4 weeks. Evaluations included severity of erythema based on Clinician's Erythema Assessment (CEA) and Patient's Self-Assessment (PSA) prior to study drug application and at 30 minutes after application on days 1, 15, and 29. RESULTS: 97.7% and 96.6% of subjects reported normal study completion for studies A and B, respectively. The percentage of subjects achieving a 1-grade improvement in both CEA and PSA was significantly increased at 30 minutes post-dosing with BT 0.5% gel compared to vehicle gel on visit days (day 1: 27.9 vs 6.9%, P <0.001; day 15: 55.9 vs 21.1%, P <0.001; Day 29: 58.3 vs 32.0%, P <0.001 for BT 0.5% gel vs vehicle) in study A. Similar results were shown for study B. CONCLUSIONS: Once-daily topical BT gel 0.5% is not only efficacious at reducing facial erythema but also exhibits response within 30 minutes of application in a significant number of patients throughout both Phase III studies.

Sumatriptan transdermal system can be correctly assembled and applied during migraine attacks.

OBJECTIVE: The objective of this study was to validate the ease of assembly and application of the sumatriptan iontophoretic transdermal system (sumatriptan TDS, Zecuity® , NuPathe, Inc., Malvern, PA, USA) during a migraine attack. BACKGROUND: Iontophoresis is a noninvasive drug delivery method using low electrical current to move solubilized drugs across the skin to the underlying tissue. With sumatriptan TDS, a pre-programmed dose of sumatriptan is automatically delivered via a transdermal patch, allowing therapeutic drug levels to be reached without mechanical penetration or disruption of the skin. Because migraine attacks can be disabling, with many patients unable to perform their usual activities, it is important for prescribers and their patients to be confident that they will be able to assemble and apply sumatriptan TDS in the middle of an attack. A human factor use study was conducted to evaluate the ease of assembly and application of the sumatriptan TDS among migraineurs and healthcare professionals (HCPs) who are likely to instruct patients on how to use the patch. METHODS: This was a single-center, open-label study assessing a single use of sumatriptan TDS in adult migraineurs and HCPs. Subjects were divided into 3 groups: migraineurs trained to use sumatriptan TDS, migraineurs not trained to use sumatriptan TDS, and HCPs not trained to use sumatriptan TDS. Sixteen subjects (trained migraineurs and untrained HCPs) participated in a preliminary usability test, and 48 subjects (16 representing each of the 3 groups) participated in a formal final test. Subjects were 20-64 years old, inclusive, and 83% female. They rated usability on a scale of 1-7, with 1 being difficult and 7 being easy. RESULTS: Preliminary testing.-Of the 16 sumatriptan TDS patches assembled and applied, 100% (16/16) were assembled and applied successfully. The mean score for ease of assembly was 6.3, and the mean score for ease of application was 6.8 out of 7, with 1 being difficult and 7 being easy. No modifications were made to patient instructions for use, patient labeling, or patient video for the final phase of testing. Final testing.-Of the 48 sumatriptan TDS patches assembled and applied during final testing, 100% (48/48) were assembled and applied successfully, with no user errors, one close call, and no operational difficulties observed. Across all 3 groups, the mean score for ease of assembly was 6.1, and the mean score for ease of application was 6.8 out of 7, with 1 being difficult and 7 being easy. For migraineurs who were trained and subsequently returned to the testing facility for evaluation of usability while in distress of a mild to severe migraine attack, the number of days between training and testing ranged from 0 to 20, with a mean of 3.6. Among untrained and trained migraineurs, 3.1% had a mild attack, 68.8% had a moderate attack, and 28.1% had a severe attack. CONCLUSIONS: The results of this study indicate that sumatriptan TDS can be assembled and applied successfully during a mild to severe migraine attack. Across all subject groups in both the preliminary and final testing, including trained and untrained migraineurs in distress of a migraine attack (96.9% moderate to severe) and untrained HCPs not experiencing a migraine attack, patch assembly and application was 100% successful. In the final test, subjects rated sumatriptan TDS very high for ease of assembly (6.1 out of 7, with 7 being easy) and ease of use (6.8 out of 7, with 7 being easy). These results indicate that patients and HCPs can be confident that patients can readily assemble and use sumatriptan TDS during a migraine attack. SHORT SUMMARY: A human factor use study evaluating ease of assembly and application of the sumatriptan transdermal system (TDS) among 64 migraineurs and HCPs found that patch assembly and application was 100% successful. Sumatriptan TDS scored 6.1 out of 7 for ease of assembly and 6.8 out of 7 for ease of use (with 7 being easy). Patients and HCPs can be confident that patients can assemble and use sumatriptan TDS during a migraine attack.

Efficacy 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 studies.

BACKGROUND: Brimonidine tartrate, a highly selective α2-adrenergic receptor agonist with potent vasoconstrictive activity, was shown to reduce erythema of rosacea. OBJECTIVE: To assess the efficacy and safety of topical brimonidine tartrate gel 0.5% for the treatment of erythema of rosacea. METHODS: Both studies were randomized, double-blind, and vehicle-controlled, with identical design. Subjects with moderate to severe erythema of rosacea were randomized 1:1 to apply topical brimonidine tartrate gel 0.5% or vehicle gel once-daily for 4 weeks, followed by a 4-week follow-up phase. Evaluations included severity of erythema based on Clinician's Erythema Assessment and Patient's Self-Assessment, as well as adverse events. RESULTS: Topical brimonidine tartrate gel 0.5% was significantly more efficacious than vehicle gel throughout 12 hours on days 1, 15, and 29, with significant difference observed as early as 30 minutes after the first application on day 1 (all P<.001). No tachyphylaxis, rebound or aggravation of other disease signs were observed. Slightly higher incidence of adverse events was observed for topical brimonidine tartrate gel 0.5% than for vehicle; however, most of the adverse events were dermatological, mild, and transient in nature. LIMITATIONS: These data generated in controlled trials may be different from those in clinical practice. CONCLUSIONS: Once-daily brimonidine tartrate gel 0.5% has a good safety profile and provides significantly greater efficacy relative to vehicle gel for the treatment of moderate to severe erythema of rosacea, as early as 30 minutes after application.