Single Center, Open Label, Study of Preparation H on Erythema in Relapsing MS Patients Treated With PLEGRIDY

Single Center, Randomized, Open Label Study in Relapsing MS Patients on PLEGRIDY to Assess Topical Application of Preparation H (Phenylephrine) on Mitigation of Erythema Severity and Size.

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.

Study Overview

• Status: Terminated
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: No Treatment Arm; Drug: Topical Preparation H arm

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group	Drug: Topical Preparation H arm; Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.
Placebo Comparator: Control group	Other: No Treatment Arm; Participants randomized to the control group will have no topical treatment at the injection site of the first full dose of Plegridy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient Erythema Self-Assessment (PSA) Score 6 hr After Application of Preparation H to First Injection Site Erythema Compared to Baseline PSA Score of Injection Site Erythema at Least 2 Hours After PLEGRIDY Injection.	6 Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Width of Injection Site Erythema in Millimeters 6 hr After Application of Preparation H to First Injection Site Erythema Compared to Baseline Width of Injection Site Erythema at Least 2 Hours After Injection.	Study was terminated. No data analyzed	6 Hours
Number of Patients Experiencing Injection Site Reaction Erythema, Itching and Pain.	Study was terminated. No data analyzed. Study was terminated. No data analyzed because the Logpad being used by subjects was flawed.	6 Hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flu-like Symptom Scale at Last Visit Compared to Base Line.	Study was terminated. No data analyzed because the Logpad being used by subjects was flawed.	6 Hours

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Jennifer Kalina, New York University Medical School

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: January 22, 2016
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimate): January 27, 2016

Study Record Updates

• Last Update Posted (Actual): January 18, 2018
• Last Update Submitted That Met QC Criteria: December 18, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; erythema
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Skin Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Skin Manifestations; Multiple Sclerosis; Sclerosis; Erythema
• Other Study ID Numbers: 15-00173

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes