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Brimonidine Tartrate for the Treatment of Injection Related Erythema | Clinical Trials | Clareo Health

WITHDRAWNPHASE4

Brimonidine Tartrate for the Treatment of Injection Related Erythema

Brimonidine Tartrate for the Treatment of Injection Related Erythema Associated With Sub-cutaneous Administration of Peginterferon Beta-1a (BRITE)

NCT02568111•Biogen

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the Injection Related Erythema (IRE) mitigation effect of a single administration of brimonidine tartrate in comparison with a vehicle gel (placebo). The secondary study objectives are to evaluate the IRE mitigation effect of a single administration of brimonidine tartrate in comparison with a vehicle gel on a more stringent definition scale, in accordance with the primary endpoint of the original brimonidine pivotal trials and participants' satisfaction with the overall appearance of their skin.

Detailed Description

Participants naïve to treatment with subcutaneous (SC) interferons or oral Disease Modifying Therapy (DMT) who are about to start PLEGRIDY PEN therapy will be screened for participation in this Phase IV trial. Participants will remain on Plegridy therapy as prescribed by their physician. Plegridy will not be provided to participants by Biogen as a part of this study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•RRMS patients naïve to treatment with SC interferon or oral and/or IV DMT for which PLEGRIDY is deemed necessary by the treating physician.
•Patient willing and able to complete PSA and PAA questionnaires with minimal assistance.

Exclusion Criteria

•Known allergy to any interferon or any component of peginterferon beta-1a.
•Patients with hypersensitivity to Brimonidine topical gel.
•Patients with other skin disorders.
•History of previous treatment with Brimonidine tartrate.

Key Dates

Start Date

February 1, 2016

Primary Completion Date

August 1, 2016

Completion Date

August 1, 2016

Last Updated

April 25, 2016

Conditions

Relapsing-Remitting Multiple Sclerosis (RRMS)

Interventions

peginterferon beta-1a

DRUG

brimonidine tartrate

DRUG

Vehicle Gel

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 25, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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