Relapsing-Remitting Multiple Sclerosis
Conditions
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.
Interventions
OTHERVitamin 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.
OTHERPlacebo 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.
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinician's Erythema Assessment (CEA) scale from pre-application of topical cream to 24 hours post-application | 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) |
| Change in Participants Erythema Self-Assessment (PSA) scale from pre-application of topical cream to 24 hours post-application | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analogue Scale (VAS) score from pre-application of topical cream to 24 hours post-application | 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) |
| Change in Adapted Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) from pre-application of topical cream to 24 hours post-application | 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. |
| Change in the longest diameter of erythema from pre-application of topical cream to 24 hours post-application | Week 4, week 6, and week 8 | Measured by the physician using a ruler before and 24 hours after the topical application of cream |
Countries
Italy
Outcome results
None listed