Safety and Efficacy of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea

Allergan

Status and phase: Completed; Phase 3

Conditions: Erythema; Rosacea

Treatments: Drug: Vehicle to Oxymetazoline HCL Cream; Drug: Oxymetazoline HCL Cream 1.0%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02132117

199201-005

Details and patient eligibility

About

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.

Enrollment: 445 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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445 participants in 2 patient groups, including a placebo group

Oxymetazoline HCL Cream 1.0%

Experimental group

Description:

Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.

Treatment:

Drug: Oxymetazoline HCL Cream 1.0%

Vehicle

Placebo Comparator group

Description:

Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.

Treatment:

Drug: Vehicle to Oxymetazoline HCL Cream