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

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ClinicalTrials.gov Identifier: NCT03091569
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief 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.


Condition or disease Intervention/treatment Phase
Relapsing-Remitting Multiple Sclerosis Other: Vitamin K Cream Other: Placebo Cream Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Effects of VITAmin K in Lessening Erythema Grade Associated to Injection Site Reactions in Patients Treated With PlegridY (VITALITY)
Actual Study Start Date : March 10, 2017
Actual Primary Completion Date : January 27, 2018
Actual Study Completion Date : January 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin K
Drug Information available for: Menadione

Arm Intervention/treatment
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 Name: Filloskin K1

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091569


Locations
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Italy
Research Site
Napoli, Italy, 80131
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen

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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT03091569     History of Changes
Other Study ID Numbers: ITA-PEG-15-10859
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Injection Site Reaction
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Extravasation of Diagnostic and Therapeutic Materials
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Vitamins
Vitamin K
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants