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

Phase 4

Completed

• Conditions: Relapsing-Remitting Multiple Sclerosis
• Interventions: Other: Vitamin K Cream; Other: Placebo Cream

• Registration Number: NCT03091569
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-10
• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-27
• Primary Completion: 2018-01-27
• Study Completion: 2018-01-27
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-04
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vitamin K	Vitamin K Cream	-
Control	Placebo Cream	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇮🇹 Napoli, Italy