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

April 4, 2018 updated by: Biogen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy, 80131
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key 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.

Key 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
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.
Active Comparator: Vitamin K
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 Names:
  • Filloskin K1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinician's Erythema Assessment (CEA) scale from pre-application of topical cream to 24 hours post-application
Time Frame: Week 4, week 6, and week 8
Erythema (redness) evaluated at the site of injection by the clinician on a scale of 0 (clear) to 4 (severe)
Week 4, week 6, and week 8
Change in Participants Erythema Self-Assessment (PSA) scale from pre-application of topical cream to 24 hours post-application
Time Frame: Week 4, week 6, and week 8
Erythema (redness) at the site of injection rated by the participant on a scale of 0 (clear) to 4 (severe)
Week 4, week 6, and week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Analogue Scale (VAS) score from pre-application of topical cream to 24 hours post-application
Time Frame: Week 4, week 6, and week 8
Severity of local pain and burning assessed by the participant on a scale of 0 (no discomfort) to 10 (maximum discomfort imaginable)
Week 4, week 6, and week 8
Change in Adapted Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) from pre-application of topical cream to 24 hours post-application
Time Frame: Week 4, week 6, and week 8
Adapted MSTQC self-administered questionnaire evaluates the sum of scores for the "injection systems satisfaction" section questions 1-9 and the "side effects" section questions 1-11, with a minimum possible total score of 20 and a maximum possible total score of 100. Lower total scores indicate better outcomes.
Week 4, week 6, and week 8
Change in the longest diameter of erythema from pre-application of topical cream to 24 hours post-application
Time Frame: Week 4, week 6, and week 8
Measured by the physician using a ruler before and 24 hours after the topical application of cream
Week 4, week 6, and week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2017

Primary Completion (Actual)

January 27, 2018

Study Completion (Actual)

January 27, 2018

Study Registration Dates

First Submitted

March 21, 2017

First Submitted That Met QC Criteria

March 21, 2017

First Posted (Actual)

March 27, 2017

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 4, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITA-PEG-15-10859

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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