Back to resultsAGN-199201 for the Treatment of Erythema With Rosacea
Primary Purpose
Rosacea, Erythema
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AGN-199201 Dose A
AGN-199201 Dose B
AGN-199201 Dose C
AGN-199201 Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea
Eligibility Criteria
Inclusion Criteria:
- Redness of the skin caused by rosacea
Exclusion Criteria:
- ≥3 inflammatory lesions
- Laser light-source or other energy based therapy in the last 6 months
- Any prescription or over the counter product for the treatment of acne or rosacea in the last 14 days
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
AGN-199201 Dose A Once Daily
AGN-199201 Dose B Once Daily
AGN-199201 Dose C Once Daily
AGN-199201 Vehicle Once Daily
AGN-199201 Dose A Twice Daily
AGN-199201 Dose B Twice Daily
AGN-199201 Dose C Twice Daily
AGN-199201 Vehicle Twice Daily
Arm Description
AGN-199201 Dose A applied once daily to the face for 28 days.
AGN-199201 Dose B applied once daily to the face for 28 days.
AGN-199201 Dose C applied once daily to the face for 28 days.
AGN-199201 Vehicle applied once daily to the face for 28 days.
AGN-199201 Dose A applied twice daily to the face for 28 days.
AGN-199201 Dose B applied twice daily to the face for 28 days.
AGN-199201 Dose C applied twice daily to the face for 28 days.
AGN-199201 Vehicle applied twice daily to the face for 28 days.
Outcomes
Primary Outcome Measures
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA)
Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed on Day 28 hours 2 to 12. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.
Secondary Outcome Measures
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 0.5 Hour Post-Dose on Day 28
Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed at 0.5 hour post-dose on Day 28. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 1 Hour Post-Dose on Day 28
Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed at 1 hour post-dose on Day 28. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01735201
Brief Title
AGN-199201 for the Treatment of Erythema With Rosacea
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
June 2013 (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 3 doses of AGN-199201 once and twice daily compared to vehicle for the treatment of 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
Rosacea, Erythema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
357 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AGN-199201 Dose A Once Daily
Arm Type
Experimental
Arm Description
AGN-199201 Dose A applied once daily to the face for 28 days.
Arm Title
AGN-199201 Dose B Once Daily
Arm Type
Experimental
Arm Description
AGN-199201 Dose B applied once daily to the face for 28 days.
Arm Title
AGN-199201 Dose C Once Daily
Arm Type
Experimental
Arm Description
AGN-199201 Dose C applied once daily to the face for 28 days.
Arm Title
AGN-199201 Vehicle Once Daily
Arm Type
Placebo Comparator
Arm Description
AGN-199201 Vehicle applied once daily to the face for 28 days.
Arm Title
AGN-199201 Dose A Twice Daily
Arm Type
Experimental
Arm Description
AGN-199201 Dose A applied twice daily to the face for 28 days.
Arm Title
AGN-199201 Dose B Twice Daily
Arm Type
Experimental
Arm Description
AGN-199201 Dose B applied twice daily to the face for 28 days.
Arm Title
AGN-199201 Dose C Twice Daily
Arm Type
Experimental
Arm Description
AGN-199201 Dose C applied twice daily to the face for 28 days.
Arm Title
AGN-199201 Vehicle Twice Daily
Arm Type
Placebo Comparator
Arm Description
AGN-199201 Vehicle applied twice daily to the face for 28 days.
Intervention Type
Drug
Intervention Name(s)
AGN-199201 Dose A
Intervention Description
AGN-199201 Dose A applied once or twice daily to the face for 28 days.
Intervention Type
Drug
Intervention Name(s)
AGN-199201 Dose B
Intervention Description
AGN-199201 Dose B applied once or twice daily to the face for 28 days.
Intervention Type
Drug
Intervention Name(s)
AGN-199201 Dose C
Intervention Description
AGN-199201 Dose C applied once or twice daily to the face for 28 days.
Intervention Type
Drug
Intervention Name(s)
AGN-199201 Vehicle
Intervention Description
AGN-199201 Vehicle applied once or twice daily to the face for 28 days.
Primary Outcome Measure Information:
Title
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA)
Description
Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed on Day 28 hours 2 to 12. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.
Time Frame
Baseline, Day 28-hours 2 to 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 0.5 Hour Post-Dose on Day 28
Description
Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed at 0.5 hour post-dose on Day 28. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.
Time Frame
Baseline, Day 28-hour 0.5
Title
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 1 Hour Post-Dose on Day 28
Description
Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed at 1 hour post-dose on Day 28. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.
Time Frame
Baseline, Day 28-hour 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Redness of the skin caused by rosacea
Exclusion Criteria:
≥3 inflammatory lesions
Laser light-source or other energy based therapy in the last 6 months
Any prescription or over the counter product for the treatment of acne or rosacea in the last 14 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Austin
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
AGN-199201 for the Treatment of Erythema With Rosacea
We'll reach out to this number within 24 hrs