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

NCT03091569 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2018-04-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-10
Primary Completion
2018-01-27
Completion
2018-01-27

Countries

  • Italy

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03091569 on ClinicalTrials.gov