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

Skin Laser & Surgery Specialists

Status: Terminated

Conditions: Erythema and Flushing Associated With Rosacea

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03508869

MG-DYS-ROS

Details and patient eligibility

About

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

Full 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

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 3 patient groups

Mirvaso® (brimonidine) topical gel, 0.33%

Active Comparator group

Description:

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.

Treatment:

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

Dysport®

Active Comparator group

Description:

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

Treatment:

Drug: Dysport®

Dysport® in conjunction with Mirvaso

Active Comparator group

Description:

Dysport® in conjunction with Mirvaso

Treatment:

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