Single Center, Open Label, Study of Preparation H on Erythema in Relapsing MS Patients Treated With PLEGRIDY
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Erythema; Sclerosis
Intervention: No Treatment Arm; Topical Preparation H arm
Intervention description: Participants randomized to the control group will have no topical treatment at the injection site of the first full dose of Plegridy.; Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Multiple Sclerosis; erythema

Summary:

      The primary purpose of this single center, randomized, open label study in relapsing Multiple
      Sclerosis (MS) patients on PLEGRIDY (peginterferon beta-1a) is to assess the effect of
      Preparation H (phenylephrine) Maximum Strength Cream compared to no topical treatment of
      injection site erythema after PLEGRIDY injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A confirmed diagnosis of relapsing multiple sclerosis, as defined by McDonald
             criteria.

          -  Age 18 to 70 years old, inclusive, at the time of informed consent.

          -  Naïve to PLEGRIDY or less than or equal to 12 months on PLEGRIDY therapy.

        Exclusion Criteria:

          -  Primary progressive, secondary progressive or progressive relapsing MS.

          -  Concurrent enrollment in any clinical trial of an investigational product.

          -  Known allergy to any interferon or any component of PLEGRIDY (peginterferon beta-1a).

          -  Known allergy to phenylephrine, pramoxane or any component of Preparation H.

          -  History of hypersensitivity or intolerance to naproxen or acetaminophen (Tylenol) that
             would preclude the use of at least 1 of these during the study.

          -  History of inadequate response to subcutaneous interferon beta therapy.

          -  History of human immunodeficiency virus, hepatitis C virus antibody or current
             hepatitis B infection.

          -  History of premalignant and malignant disease including solid tumors and hematologic
             malignancies (except basal cell and squamous cell carcinomas of the skin that have
             been completely excised and are considered cured).

          -  History of any clinically significant cardiac, endocrinologic, hematologic, hepatic,
             immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric,
             and renal, or other major disease, as determined by the Investigator.

          -  History of seizure disorder or unexplained blackouts.

          -  History of suicidal ideation or an episode of clinically severe depression (as
             determined by the Investigator) within 3 months prior to Day 1.

          -  Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g.,
             pneumonia, septicemia), at the discretion of the Investigator, within 3 months prior
             to Day 1.

          -  History of drug or alcohol abuse (as defined by the Investigator) within 6 months
             prior to Day.

          -  Active bacterial or viral infection.

          -  Inability to comply with study requirements.