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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin K | Active Comparator |
| |
| Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Naples | 80131 | Italy |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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|
| 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. |
|
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 |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |