Skip to main content
OpenTrials
Completed

NCT Number: NCT03091569

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Relapsing-Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin K Cream

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.

Other names: Filloskin K1

Placebo Cream

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.

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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)

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Acronym: VITALITY

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 27, 2017
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.