Safety and Efficacy of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea
Overview
- Phase
- Phase 3
- Intervention
- Oxymetazoline HCL Cream 1.0%
- Conditions
- Erythema
- Sponsor
- Allergan
- Enrollment
- 445
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Oxymetazoline HCL Cream 1.0%
Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
Intervention: Oxymetazoline HCL Cream 1.0%
Vehicle
Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
Intervention: Vehicle to Oxymetazoline HCL Cream
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
Time Frame: Baseline, Day 29 (Hours 3, 6, 9 and 12)
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.
Secondary Outcomes
- Percentage of Participants Satisfied or Very Satisfied on Item #9 of Satisfaction Assessment for Rosacea Facial Redness (SAT-RFR) at Hours 3, 6, 9 and 12 on Day 29(Day 29 (Hours 3, 6, 9 and 12))
- 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(Baseline, Day 29 (Hours 3, 6, 9 and 12))
- Percentage of Participants With at Least a 1-Grade Improvement (Decrease) From Baseline on SSA at Hour 1 on Day 1(Baseline, Day 1 (Hour 1))
- Change From Baseline on the Symptom Assessment for Rosacea Facial Redness (SA-RFR) Item # 4 at Hours 3, 6, 9 and 12 on Day 29(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(Baseline, Day 29 (Hours 3, 6, 9 and 12))