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

Phase 3

Completed

• Conditions: Erythema; Rosacea
• Interventions: Drug: Vehicle to Oxymetazoline HCL Cream; Drug: Oxymetazoline HCL Cream 1.0%

• Registration Number: NCT02132117
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-05
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-07
• Study Start: 2014-06
• Primary Completion: 2015-04
• Study Completion: 2015-05
• Results First Submitted: 2016-06-22
• Results First Submitted QC: 2016-06-22
• Results First Posted: 2016-08-02
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 445

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle to Oxymetazoline HCL Cream	Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
Oxymetazoline HCL Cream 1.0%	Oxymetazoline HCL Cream 1.0%	Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
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)	Participants assessed their treatment satisfaction by answering Item #9 of the SAT-RFR: "Right now, how satisfied are you with the effect your study medication had on your facial redness?" using a 5-point scale where 0= very dissatisfied, 1=dissatisfied, 2=neither satisfied or dissatisfied, 3=satisfied, or 4=very satisfied. The percentage of participants who answered Satisfied or Very Satisfied is reported.
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)	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.
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)	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.
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)	Participants assessed the burning sensation associated with rosacea facial redness by answering Item #4 of the SA-RFR: "Right now, how much does your face burn because of your facial redness?" using a 5-point scale where 0=less severe to 4=severe. A negative change from Baseline indicates improvement.
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)	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.