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

Multiple Sclerosis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02665221
• Other study ID #: 15-00173
• Status: Terminated
• Phase: Phase 4
• First received: January 22, 2016
• Last updated: December 18, 2017
• Start date: July 2015
• Est. completion date: September 2016

Study information

• Verified date: December 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erythema
• Multiple Sclerosis
• Sclerosis

Intervention

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.

Drug:
• Topical Preparation H arm
Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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