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

NCT ID: NCT03091569

Last Updated: 2018-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-10

Study Completion Date

2018-01-27

Brief Summary

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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.

Detailed Description

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Conditions

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Relapsing-Remitting Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vitamin K

Group Type ACTIVE_COMPARATOR

Vitamin K Cream

Intervention Type OTHER

To be applied topically 3 times in 24 hours (approximately at 8 and 16 hours post initial application) from the appearance of the erythema.

Control

Group Type PLACEBO_COMPARATOR

Placebo Cream

Intervention Type OTHER

To be applied topically 3 times in 24 hours (approximately at 8 and 16 hours post initial application) from the appearance of the erythema.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Filloskin K1

Eligibility Criteria

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Inclusion Criteria

* Relapsing-Remitting Multiple Sclerosis (RRMS) participants for which Plegridy is deemed necessary by the neurologist. Participants switching from other Disease Modifying Treatments (DMTs) will be eligible provided that Plegridy is administered at an injection site different from the previous one.

Exclusion Criteria

* Participants with other skin disorders
* Pregnancy or current breast-feeding
* Depression and other psychiatric disorders
* Unwillingness or inability to comply with the requirements of the protocol.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Research Site

Napoli, , Italy

Site Status

Countries

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Italy

Other Identifiers

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ITA-PEG-15-10859

Identifier Type: -

Identifier Source: org_study_id

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