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

Study Overview
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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.

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

Conditions
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Relapsing-Remitting Multiple Sclerosis

Intervention / Treatment
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* Other: Vitamin K Cream
* Other: Placebo Cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin K<br> | Other: Vitamin K Cream<br>* To be applied topically 3 times in 24 hours (approximately at 8 and 16 hours post initial application) from the appearance of the erythema.<br>* Other names: Filloskin K1;|
| Placebo Comparator: Control<br> | Other: Placebo Cream<br>* To be applied topically 3 times in 24 hours (approximately at 8 and 16 hours post initial application) from the appearance of the erythema.<br>|

What is the study measuring?
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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 | 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 | 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 | 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 | 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 | Measured by the physician using a ruler before and 24 hours after the topical application of cream | Week 4, week 6, and week 8 |