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

NCT ID: NCT02095158

Last Updated: 2019-11-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Erythema Rosacea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oxymetazoline HCL Cream 1.0%

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

Group Type EXPERIMENTAL

Oxymetazoline HCL Cream 1.0%

Intervention Type DRUG

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

Interventions

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Oxymetazoline HCL Cream 1.0%

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

Intervention Type DRUG

Other Intervention Names

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AGN-199201

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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199201-006

Identifier Type: -

Identifier Source: org_study_id

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