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

NCT03091569 | Completed Phase 4

• 1 other identifier: ITA-PEG-15-10859
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsing-Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (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

• 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

• 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

Study Arms (2)

Vitamin K

ACTIVE COMPARATOR

Other: Vitamin K Cream

Control

PLACEBO COMPARATOR

Other: Placebo Cream

Interventions

Vitamin K Cream OTHER

To be applied topically 3 times in 24 hours (approximately at 8 and 16 hours post initial application) from the appearance of the erythema.

Also known as: Filloskin K1

Vitamin K

Placebo Cream OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Napoli, 80131, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: March 10, 2017
• Primary Completion: January 27, 2018
• Study Completion: January 27, 2018
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

IT (1)