Erythema | Safety and Efficacy of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea
Erythema research study
What is the primary objective of this study?
This study will evaluate the safety and efficacy of oxymetazoline hydrochloride (HCl) cream 1.0% (AGN-199201) once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea.
Who is eligible to participate?
Inclusion Criteria: -Moderate to severe persistent facial erythema associated with rosacea. Exclusion Criteria: - Greater than 3 inflammatory lesions on the face - 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?
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% (AGN-199201) applied to the face once daily for 29 days.
Drug:Vehicle to Oxymetazoline HCL CreamVehicle to Oxymetazoline HCL Cream (AGN-199201) applied to the face once daily for 29 days.
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% applied to the face once daily for 29 days.
VehicleVehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
Start Date: June 2014
Completed Date: May 2015
Phase: Phase 3
Primary Outcome: Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment for Rosacea Facial Redness (SSA) 5-point Scales
Secondary Outcome: Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on SSA at Hours 3, 6, 9 and 12 on Day 29
Study sponsors, principal investigator, and references
Principal Investigator: Medical Director
Lead Sponsor: Allergan