Safety and Efficacy of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea
Primary Purpose
Erythema, Rosacea
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Oxymetazoline HCL Cream 1.0%
Vehicle to Oxymetazoline HCL Cream
Sponsored by
About this trial
This is an interventional treatment trial for Erythema
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Oxymetazoline HCL Cream 1.0%
Vehicle
Arm Description
Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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
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.
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
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.
Percentage of Participants With at Least a 1-Grade Improvement (Decrease) From Baseline on SSA at Hour 1 on Day 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02132117
Brief Title
Safety and Efficacy of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythema, Rosacea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
445 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxymetazoline HCL Cream 1.0%
Arm Type
Experimental
Arm Description
Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
Intervention Type
Drug
Intervention Name(s)
Oxymetazoline HCL Cream 1.0%
Intervention Description
Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 29 days.
Intervention Type
Drug
Intervention Name(s)
Vehicle to Oxymetazoline HCL Cream
Intervention Description
Vehicle to Oxymetazoline HCL Cream (AGN-199201) applied to the face once daily for 29 days.
Primary Outcome Measure Information:
Title
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
Description
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 Outcome Measure Information:
Title
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
Description
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)
Title
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
Description
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.
Time Frame
Baseline, Day 29 (Hours 3, 6, 9 and 12)
Title
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
Description
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.
Time Frame
Day 29 (Hours 3, 6, 9 and 12)
Title
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
Description
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.
Time Frame
Baseline, Day 29 (Hours 3, 6, 9 and 12)
Title
Percentage of Participants With at Least a 1-Grade Improvement (Decrease) From Baseline on SSA at Hour 1 on Day 1
Description
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.
Time Frame
Baseline, Day 1 (Hour 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
College Station
State/Province
Texas
Country
United States
12. IPD Sharing Statement
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Safety and Efficacy of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea
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