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

Biogen

Status and phase: Completed; Phase 4

Conditions: Relapsing-Remitting Multiple Sclerosis

Treatments: Other: Placebo Cream; Other: Vitamin K Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT03091569

ITA-PEG-15-10859

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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/Exclusion criteria may apply

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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23 participants in 2 patient groups, including a placebo group

Vitamin K

Active Comparator group

Treatment:

Other: Vitamin K Cream

Control

Placebo Comparator group

Treatment:

Other: Placebo Cream