A Long-term Safety and Efficacy Study of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea

Allergan0 sites440 target enrollmentApril 2014

ConditionsErythema Rosacea

InterventionsOxymetazoline HCL Cream 1.0%

DrugsOxymetazoline HCL Cream 1.0%

Overview

Phase: Phase 3
Intervention: Oxymetazoline HCL Cream 1.0%
Conditions: Erythema
Sponsor: Allergan
Enrollment: 440
Primary Endpoint: Percentage of Participants With Treatment-Related Adverse Events
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

September 2015

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Allergan

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Oxymetazoline HCL Cream 1.0%

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

Intervention: Oxymetazoline HCL Cream 1.0%

Outcomes

Primary Outcomes

Percentage of Participants With Treatment-Related Adverse Events

Time Frame: 56 Weeks

An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A Treatment-Related Adverse Event is an Adverse Event determined by the investigator to be causally related to the study medication.

Secondary Outcomes

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(Baseline, Day 1 Hours 3 and 6, Week 4 Predose and Hours 3 and 6, Week 12 Predose, Week 26 Predose and Hours 3 and 6, Week 39 Predose, Week 52 Predose and Hours 3 and 6, Week 54 Predose)