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sponsor asked site to suspend study.
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| Name | Class |
|---|---|
| Galderma R&D | INDUSTRY |
To evaluate the safety and efficacy of Mirvaso® Gel and Dysport® for erythema and flushing of Rosacea.
To assess the improvement of facial erythema and flushing while using Mirvaso® and Dysport® treatments based on the clinician's and patient's assessments using a verified 5-point grading scale
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirvaso® (brimonidine) topical gel, 0.33% | Active Comparator | Mirvaso® (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent facial erythema of rosacea in adults 18 years of age or older. |
|
| Dysport® | Active Comparator | Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent. |
|
| Dysport® in conjunction with Mirvaso | Active Comparator | Dysport® in conjunction with Mirvaso |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirvaso® (brimonidine) topical gel, 0.33% | Drug | Mirvaso® (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent facial erythema of rosacea in adults 18 years of age or older. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Assessments for Erythema | % of subjects who achieve a grade of 0 or 1 on the 5-point grading scale for Erythema 6 months post Dysport treatment Subject achieving a grade of 0 or 1 or ≥ 2 grade of improvement from baseline at 6 months for Erythema on the 5-point grading scale. | 6 months |
| Efficacy Assessments for Flushing | % of subjects who achieve a grade of 0 or 1 on the 5-point grading scale for Flushing 6 months post Dysport treatment Subject achieving a grade of 0 or 1 or ≥ 2 grade of improvement from baseline at 6 months for Flushing on the 5-point grading scale. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessments | Safety evaluations will be performed at all visits. Adverse events, local tolerability (dryness, pruritus burning/stinging) and a facial exam will be performed for all visits. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D004890 | Erythema |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| D005782 | Gels |
| C542869 | abobotulinumtoxinA |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Dysport® | Drug | Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent. |
|
|
| Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33% | Drug | Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33% |
|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |