Effects of Vitamin K on Redness Associated With Injection Site Reactio
Effects of VITAmin K in Lessening Erythema Grade Associated to Injection Site Reactions in Patients Treated With PlegridY (VITALITY)
What it found
We found no results in the registry or in papers.
This trial finished 8 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Vitamin K Cream
Placebo
- Placebo Cream
What it measured
Main measures
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
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
Other measures (3)
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
PainChange 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
Quality of life (reported by participants)SafetyChange in the longest diameter of erythema from pre-application of topical cream to 24 hours post-application
Week 4, week 6, and week 8
Who could take part
Relapsing MS · 18 and over
Show the full criteria
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/Exclusion criteria may apply
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Loading reviews and guidelines…
History
Started
Mar 2017
Main results due
Jan 2018
Finished
Jan 2018