Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 440
- Primary Endpoint
- Percentage of Patients With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) 5-point Scales
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
AGN-199201
AGN-199201 applied to the face once daily for 29 days.
Intervention: AGN-199201 (Drug)
Vehicle
Vehicle to AGN-199201 applied to the face once daily for 29 days.
Intervention: Vehicle to AGN-199201 (Drug)
Outcomes
Primary Outcomes
Percentage of Patients With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) 5-point Scales
Time Frame: Baseline, Day 29 (Hours 3, 6, 9, and 12)
The investigator assessed the patient's overall severity of erythema in the treatment area on the 5 point CEA scale (ranging from 0=clear skin with no signs of erythema to 4=severe erythema/fiery redness). The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients 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) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.
Secondary Outcomes
- Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale(Baseline, Day 29 (Hours 3, 6, 9, and 12))
- Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA)(Baseline, Day 29 (Hours 3, 6, 9, and 12))
- Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9(Day 29 (Hours 3, 6, 9, and 12))
- Change From Baseline on the SA-RFR Questionnaire Item #4(Baseline, Day 29 (Hours 3, 6, 9, and 12))
- Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale(Baseline, Day 1 (Hour 1))