Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea

Allergan

Status and phase: Completed; Phase 3

Conditions: Erythema; Rosacea

Treatments: Drug: AGN-199201; Drug: Vehicle to AGN-199201

Study type: Interventional

Funder types: Industry

Identifiers

NCT02131636

199201-004

Details and patient eligibility

About

This study will evaluate the safety and efficacy of AGN-199201 once daily compared to vehicle for the treatment of persistent moderate to severe facial 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

• 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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440 participants in 2 patient groups, including a placebo group

AGN-199201

Experimental group

Description:

AGN-199201 applied to the face once daily for 29 days.

Treatment:

Drug: AGN-199201

Vehicle

Placebo Comparator group

Description:

Vehicle to AGN-199201 applied to the face once daily for 29 days.

Treatment:

Drug: Vehicle to AGN-199201