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

Allergan445 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

445

Conditions

Erythema Rosacea

Interventions

Oxymetazoline HCL Cream 1.0%DRUG

Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 29 days.

Vehicle to Oxymetazoline HCL CreamDRUG

Vehicle to Oxymetazoline HCL Cream (AGN-199201) applied to the face once daily for 29 days.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

College Station, Texas, United States

Outcomes

Primary Outcomes

Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment for Rosacea Facial Redness (SSA) 5-point Scales

The investigator assessed the participant's overall severity of erythema in the treatment area by using the 5-point CEA scale with photonumeric guide where: 0=clear skin with no signs of erythema (best) to 4=severe erythema; fiery redness (worst). A decrease in the score indicates improvement. The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants with at least a 2-grade decrease (improvement) on both CEA and SSA from Baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) post-dose on Day 29. Baseline was defined as the measurement at pre-dose on Day 1.

Time frame: Baseline, Day 29 (Hours 3, 6, 9 and 12)

Secondary Outcomes

Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on SSA at Hours 3, 6, 9 and 12 on Day 29

The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants with at least a 2-grade decrease (improvement) on SSA from Baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) post-dose on Day 29.

Time frame: Baseline, Day 29 (Hours 3, 6, 9 and 12)

Percent Change From Baseline on Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA) at Hours 3, 6, 9 and 12 on Day 29

DIA of photographs was used to assess rosacea facial redness and was defined as percentage of facial area occupied by redness. A higher value in the percentage of facial area occupied by facial redness indicated more redness. A negative/ lower number percent change from Baseline indicates improvement.

Data from ClinicalTrials.gov

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