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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
23
To be applied topically 3 times in 24 hours (approximately at 8 and 16 hours post initial application) from the appearance of the erythema.
To be applied topically 3 times in 24 hours (approximately at 8 and 16 hours post initial application) from the appearance of the erythema.
Research Site
Napoli, Italy
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)
Time frame: 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)
Time frame: Week 4, week 6, and week 8
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)
Time frame: 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.
Time frame: 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
Time frame: Week 4, week 6, and week 8
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