NCT02856919

A Multicenter, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Once Daily Mirvaso® Gel in Patients With Chronic Persistent Vascular Facial Erythema.

A Multicenter, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Once Daily Mirvaso® Gel (5 mg/g Brimonidine Tartrate) in Patients With Chronic Persistent Vascular Facial Erythema.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Galderma Brasil Ltda. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the efficacy of Mirvaso® in the treatment of chronic persistent vascular facial erythema, after 4 weeks of treatment, by the Clinician erythema assessment.

Detailed description

This is a multicenter, open-label trial in research participants with chronic persistent vascular facial erythema. All eligible research participants will receive Mirvaso® gel once daily for 4 weeks, and then will be followed-up for another 2 weeks. The study will include 4 clinical visits: before Day 1, on Day 1, Day 29 and Week 6. Within 5 days before Day 1, the research participant will have a screening visit for confirmation of eligibility. On Day 1 and on Day 29, the research participant will have Mirvaso® gel applied, at the research site, and the evaluation will be conducted before application and 3 hours after application; During Days 2-28, research participants will have Mirvaso® gel applied once daily, at home; On Week 6, the research participants will go back to the research site for evaluation. No Mirvaso® gel will be applied after the visit on Day 29; Unscheduled visits may be performed during the trial for any safety reason.

Conditions

• Chronic Persistent Vascular Facial Erythema

Interventions

Type	Name	Description
DRUG	brimonidine tartrate	Mirvaso® gel (5 mg/g brimonidine tartrate)

Timeline

• Start date: 2016-06-13
• Primary completion: 2017-02-08
• Completion: 2017-02-08
• First posted: 2016-08-05
• Last updated: 2017-04-06

Locations

5 sites across 1 country: Brazil