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Erythema | A Long-Term Safety and Efficacy Study AGN-19920 in Patients With Persistent Erythema Associated With Rosacea

Erythema research study

What is the primary objective of this study?

This study will evaluate the long-term safety and efficacy of oxymetazoline hydrogen chloride (HCL) Cream 1.0% (AGN-199201) in patients with persistent erythema associated with rosacea.

Who is eligible to participate?

Inclusion Criteria: -Moderate to severe persistent facial erythema associated with rosacea. Exclusion Criteria: - Current treatment with monoamine oxidase (MAO) inhibitors - Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or Sjogren's syndrome.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Erythema

Rosacea

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Oxymetazoline HCL Cream 1.0%Oxymetazoline HCL Cream 1.0% applied to the face once daily for 52 weeks.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Oxymetazoline HCL Cream 1.0%Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.

Study Status

Completed

Start Date: April 2014

Completed Date: September 2015

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Percentage of Participants With Treatment-Related Adverse Events

Secondary Outcome: Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales

Study sponsors, principal investigator, and references

Principal Investigator: Medical Director

Lead Sponsor: Allergan

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02095158

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