NCT03091569

Effects of Vitamin K on Redness Associated With Injection Site Reactions in Participants Treated With Plegridy

Effects of VITAmin K in Lessening Erythema Grade Associated to Injection Site Reactions in Patients Treated With PlegridY (VITALITY)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to investigate whether topical Vitamin K application reduces the grade of erythema in comparison with a vehicle cream (placebo) through physicians' assessment and participant self-assessment. The secondary objectives of this study are to evaluate in this study population: effects of Vitamin K in reducing the burning sensation and local pain; effects of Vitamin K in reducing the erythema diameter; and the evaluation of participants' satisfaction related to the injection treatment.

Conditions

• Relapsing-Remitting Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Vitamin K Cream	To be applied topically 3 times in 24 hours (approximately at 8 and 16 hours post initial application) from the appearance of the erythema.
OTHER	Placebo Cream	To be applied topically 3 times in 24 hours (approximately at 8 and 16 hours post initial application) from the appearance of the erythema.

Timeline

• Start date: 2017-03-10
• Primary completion: 2018-01-27
• Completion: 2018-01-27
• First posted: 2017-03-27
• Last updated: 2018-04-05

Locations

1 site across 1 country: Italy