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

Allergan

Status and phase: Completed; Phase 3

Conditions: Erythema; Rosacea

Treatments: Drug: Oxymetazoline HCL Cream 1.0%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02095158

199201-006

Details and patient eligibility

About

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.

Enrollment: 440 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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440 participants in 1 patient group

Oxymetazoline HCL Cream 1.0%

Experimental group

Description:

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

Treatment:

Drug: Oxymetazoline HCL Cream 1.0%