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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02856919
Study type Interventional
Source Galderma Brasil Ltda.
Contact
Status Completed
Phase Phase 4
Start date June 13, 2016
Completion date February 8, 2017