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

Relapsing-Remitting Multiple Sclerosis Clinical Trial

— VITALITY  

Official title:

Effects of VITAmin K in Lessening Erythema Grade Associated to Injection Site Reactions in Patients Treated With PlegridY (VITALITY)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03091569
• Other study ID #: ITA-PEG-15-10859
• Status: Completed
• Phase: Phase 4
• First received: March 21, 2017
• Last updated: April 4, 2018
• Start date: March 10, 2017
• Est. completion date: January 27, 2018

Study information

• Verified date: April 2018
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 27, 2018
• Est. primary completion date: January 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Italy	Research Site	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinician's Erythema Assessment (CEA) scale from pre-application of topical cream to 24 hours post-application	Erythema (redness) evaluated at the site of injection by the clinician on a scale of 0 (clear) to 4 (severe)	Week 4, week 6, and week 8
Primary	Change in Participants Erythema Self-Assessment (PSA) scale from pre-application of topical cream to 24 hours post-application	Erythema (redness) at the site of injection rated by the participant on a scale of 0 (clear) to 4 (severe)	Week 4, week 6, and week 8
Secondary	Change in Visual Analogue Scale (VAS) score from pre-application of topical cream to 24 hours post-application	Severity of local pain and burning assessed by the participant on a scale of 0 (no discomfort) to 10 (maximum discomfort imaginable)	Week 4, week 6, and week 8
Secondary	Change in Adapted Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) from pre-application of topical cream to 24 hours post-application	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.	Week 4, week 6, and week 8
Secondary	Change in the longest diameter of erythema from pre-application of topical cream to 24 hours post-application	Measured by the physician using a ruler before and 24 hours after the topical application of cream	Week 4, week 6, and week 8