Single Center, Open Label, Study of Preparation H on Erythema in Relap
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.
What it found
The trial ended early for another reason (see below).
Reason given: It was decided on 9/21/2016 to terminate this study early because LogPad devices the patients used to record their injection data was flawed
What was tested
Treatment tested
- Topical Preparation H arm
Placebo
- No Treatment Arm
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Control Group | 15 | 0 (0.0%) | 0 |
| Treatment Group | 15 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
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
Safety
Other measures (2)
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
SafetyNumber of Patients Experiencing Injection Site Reaction Erythema, Itching and Pain.
6 Hours
PainSafety
Who could take part
Relapsing MS · 18 to 70
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Jul 2015
Main results due
Sept 2016
Finished
Sept 2016
Results posted
Jan 2018