Back to resultsEfficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea
Primary Purpose
Erythema, Rosacea
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AGN-199201
Vehicle to AGN-199201
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
AGN-199201
Vehicle
Arm Description
AGN-199201 applied to the face once daily for 29 days.
Vehicle to AGN-199201 applied to the face once daily for 29 days.
Outcomes
Primary Outcome Measures
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
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 Outcome Measures
Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale
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) 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.
Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA)
Rosacea facial redness in the treatment area was measured by DIA. The percent change 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. A negative number change from baseline indicates a decrease in facial redness (improvement), and a positive number change from baseline indicates an increase in facial redness (worsening).
Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9
The SA-RFR questionnaire item 9 is completed by patients assessing treatment satisfaction on facial redness. Patients reporting treatment satisfaction as "very satisfied" or "satisfied" are noted. The percentage of patients was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29.
Change From Baseline on the SA-RFR Questionnaire Item #4
The SA-RFR questionnaire item 4 is completed by patients assessing how much their face burned due to facial redness on a 5 point scale (range 0=does not burn at all and 4=burns a lot). Patients were evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29. A lower score change from baseline (negative number) indicates a decrease in facial redness (improvement), and a higher score change from baseline (positive number) indicates an increase in facial burning (worsening).
Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale
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 1 grade decrease (improvement) on the SSA from baseline at Day 1 hour 1. Baseline was defined as the measurement at predose on Day 1.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02131636
Brief Title
Efficacy and Safety of AGN-199201 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
May 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (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 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
440 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AGN-199201
Arm Type
Experimental
Arm Description
AGN-199201 applied to the face once daily for 29 days.
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle to AGN-199201 applied to the face once daily for 29 days.
Intervention Type
Drug
Intervention Name(s)
AGN-199201
Intervention Description
AGN-199201 applied to the face once daily for 29 days.
Intervention Type
Drug
Intervention Name(s)
Vehicle to AGN-199201
Intervention Description
Vehicle to AGN-199201 applied to the face once daily for 29 days.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline, Day 29 (Hours 3, 6, 9, and 12)
Secondary Outcome Measure Information:
Title
Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale
Description
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) 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.
Time Frame
Baseline, Day 29 (Hours 3, 6, 9, and 12)
Title
Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA)
Description
Rosacea facial redness in the treatment area was measured by DIA. The percent change 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. A negative number change from baseline indicates a decrease in facial redness (improvement), and a positive number change from baseline indicates an increase in facial redness (worsening).
Time Frame
Baseline, Day 29 (Hours 3, 6, 9, and 12)
Title
Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9
Description
The SA-RFR questionnaire item 9 is completed by patients assessing treatment satisfaction on facial redness. Patients reporting treatment satisfaction as "very satisfied" or "satisfied" are noted. The percentage of patients was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29.
Time Frame
Day 29 (Hours 3, 6, 9, and 12)
Title
Change From Baseline on the SA-RFR Questionnaire Item #4
Description
The SA-RFR questionnaire item 4 is completed by patients assessing how much their face burned due to facial redness on a 5 point scale (range 0=does not burn at all and 4=burns a lot). Patients were evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29. A lower score change from baseline (negative number) indicates a decrease in facial redness (improvement), and a higher score change from baseline (positive number) indicates an increase in facial burning (worsening).
Time Frame
Baseline, Day 29 (Hours 3, 6, 9, and 12)
Title
Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale
Description
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 1 grade decrease (improvement) on the SSA from baseline at Day 1 hour 1. Baseline was defined as the measurement at predose on Day 1.
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
Lynchburg
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea
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