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

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

Study Overview

• Status: Terminated
• Conditions: Erythema and Flushing Associated With Rosacea
• Intervention / Treatment: Drug: Mirvaso® (brimonidine) topical gel, 0.33%; Drug: Dysport®; Drug: Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or female
2. 18 years of age or older
3. Clinical diagnosis of rosacea
4. 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)
5. No known medical conditions that may interfere with study participation
6. Willingness to not use any products on their face for the duration of the study
7. Read, understand, and sign informed consent forms
8. Willingness to sign photography release form
9. Willing and able to comply with all follow-up requirements
10. Willingness to undergo treatment using Mirvaso® Gel and Dysport®

Exclusion Criteria:

1. Any significant skin disease at treatment area
2. Any medical condition which could interfere with the treatment
3. Inability or unwillingness to follow the treatment schedule
4. Inability or unwillingness to sign the informed consent
5. Pregnant or lactating
6. Allergy to cow's milk protein
7. Previous or current use of Mirvaso® Gel
8. Known hypersensitivity to Dysport® , Mirvaso® Gel or any of their ingredients
9. Previous Dysport® treatment 6 months prior to the screening visit

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Skin Laser & Surgery Specialists
• Collaborators: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2016
• Primary Completion (Actual): September 20, 2017
• Study Completion (Actual): September 20, 2017

Study Registration Dates

• First Submitted: May 19, 2016
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Rosacea; Erythema; Flushing; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Peripheral Nervous System Agents; Cholinergic Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Brimonidine Tartrate; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: MG-DYS-ROS