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.

NYU Langone Health1 site in 1 country30 target enrollmentJuly 2015

ConditionsMultiple Sclerosis

InterventionsNo Treatment Arm Topical Preparation H arm

DrugsTopical Preparation H arm

Overview

Phase: Phase 4
Intervention: No Treatment Arm
Conditions: Multiple Sclerosis
Sponsor: NYU Langone Health
Enrollment: 30
Locations: 1
Primary Endpoint: 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.
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 2015

End Date

September 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

NYU Langone Health

Responsible Party

Sponsor

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.

Arms & Interventions

Control group

Intervention: No Treatment Arm

Treatment group

Intervention: Topical Preparation H arm

Outcomes

Primary Outcomes

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.

Time Frame: 6 Hours

Secondary Outcomes

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.(6 Hours)
Number of Patients Experiencing Injection Site Reaction Erythema, Itching and Pain.(6 Hours)