Mirvaso® Gel and Dysport® for Erythema and Flushing of Rosacea

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of Mirvaso® Gel and Dysport® for erythema and flushing of Rosacea.

Detailed Description
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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

Conditions
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Erythema and Flushing Associated With Rosacea

Intervention / Treatment
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* Drug: Mirvaso® (brimonidine) topical gel, 0.33%
* Drug: Dysport®
* Drug: Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 years of age or older Clinical diagnosis of rosacea Moderate to severe persistent facial erythema associated with rosacea at baseline, as determined by: a grade of greater than or equal to 3 on the 5 point grading scale1 (Figure 1) No known medical conditions that may interfere with study participation Willingness to not use any products on their face for the duration of the study Read, understand, and sign informed consent forms Willingness to sign photography release form Willing and able to comply with all follow-up requirements Willingness to undergo treatment using Mirvaso® Gel and Dysport® Exclusion Criteria: Any significant skin disease at treatment area Any medical condition which could interfere with the treatment Inability or unwillingness to follow the treatment schedule Inability or unwillingness to sign the informed consent Pregnant or lactating Allergy to cow's milk protein Previous or current use of Mirvaso® Gel Known hypersensitivity to Dysport® , Mirvaso® Gel or any of their ingredients Previous Dysport® treatment 6 months prior to the screening visit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mirvaso® (brimonidine) topical gel, 0.33%<br>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. | Drug: Mirvaso® (brimonidine) topical gel, 0.33%<br>* 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.<br>|
| Active Comparator: Dysport®<br>Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent. | Drug: Dysport®<br>* Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent.<br>* Other names: Dysport® (abobotulinumtoxinA);|
| Active Comparator: Dysport® in conjunction with Mirvaso<br>Dysport® in conjunction with Mirvaso | Drug: Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%<br>* Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |