Effects of Vitamin K on Redness Associated With Injection Site Reactions in Participants Treated With Plegridy
NCT ID: NCT03091569
Last Updated: 2018-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
23 participants
INTERVENTIONAL
2017-03-10
2018-01-27
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Vitamin K
Vitamin 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.
Control
Placebo 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.
Interventions
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Vitamin 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.
Placebo 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy or current breast-feeding
* Depression and other psychiatric disorders
* Unwillingness or inability to comply with the requirements of the protocol.
18 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Napoli, , Italy
Countries
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Other Identifiers
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ITA-PEG-15-10859
Identifier Type: -
Identifier Source: org_study_id
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