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

NCT03508869 | Terminated

• 1 other identifier: MG-DYS-ROS
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Erythema and Flushing Associated With Rosacea

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Safety Assessments

  6 months

Study Arms (3)

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.

Drug: Mirvaso® (brimonidine) topical gel, 0.33%

Dysport®

ACTIVE COMPARATOR

Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent.

Drug: Dysport®

Dysport® in conjunction with Mirvaso

ACTIVE COMPARATOR

Dysport® in conjunction with Mirvaso

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

Interventions

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.

Mirvaso® (brimonidine) topical gel, 0.33%

Dysport® DRUG

Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent.

Also known as: Dysport® (abobotulinumtoxinA)

Dysport®

Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33% DRUG

Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%

Dysport® in conjunction with Mirvaso

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• 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®

You may not qualify if:

• 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

Sponsors & Collaborators

• Skin Laser & Surgery Specialists: lead
• Galderma R&D: collaborator

MeSH Terms

Conditions

Erythema

Interventions

Brimonidine Tartrate; Gels; abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: April 26, 2018
• Study Start: September 27, 2016
• Primary Completion: September 20, 2017
• Study Completion: September 20, 2017
• Last Updated: April 18, 2023

Record last verified: 2023-04