Erythema, Rosacea
Conditions
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.
Interventions
DRUGAGN-199201 Dose A
AGN-199201 Dose A applied once or twice daily to the face for 28 days.
DRUGAGN-199201 Dose B
AGN-199201 Dose B applied once or twice daily to the face for 28 days.
DRUGAGN-199201 Dose C
AGN-199201 Dose C applied once or twice daily to the face for 28 days.
AGN-199201 Vehicle applied once or twice daily to the face for 28 days.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Baseline, Day 28-hours 2 to 12 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, Day 28-hour 0.5 | 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 | Baseline, Day 28-hour 1 | 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. |
Countries
United States
Participant flow
Pre-assignment details
357 patients were randomized; 1 patient in error. 356 patients were included in the Modified intent-to-treat and Safety populations.
Participants by arm
| Arm | Count |
|---|---|
| AGN-199201 Dose A Once Daily AGN-199201 Dose A applied once daily to the face for 28 days. | 45 |
| AGN-199201 Dose B Once Daily AGN-199201 Dose B applied once daily to the face for 28 days. | 44 |
| AGN-199201 Dose C Once Daily AGN-199201 Dose C applied once daily to the face for 28 days. | 44 |
| AGN-199201 Vehicle Once Daily AGN-199201 Vehicle applied once daily to the face for 28 days. | 44 |
| AGN-199201 Dose A Twice Daily AGN-199201 Dose A applied twice daily to the face for 28 days. | 45 |
| AGN-199201 Dose B Twice Daily AGN-199201 Dose B applied twice daily to the face for 28 days. | 45 |
| AGN-199201 Dose C Twice Daily AGN-199201 Dose C applied twice daily to the face for 28 days. | 45 |
| AGN-199201 Vehicle Twice Daily AGN-199201 Vehicle applied twice daily to the face for 28 days. | 44 |
| Total | 356 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 | 1 | 1 | 3 | 2 | 1 |
| Overall Study | Other Miscellaneous Reasons | 0 | 0 | 0 | 1 | 0 | 2 | 1 | 1 |
| Overall Study | Personal Reasons | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | AGN-199201 Vehicle Twice Daily | 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 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized 45-64 years | 28 Participants | 30 Participants | 23 Participants | 28 Participants | 24 Participants | 26 Participants | 29 Participants | 27 Participants | 215 Participants |
| Age, Customized < 45 years | 9 Participants | 14 Participants | 15 Participants | 10 Participants | 14 Participants | 16 Participants | 11 Participants | 16 Participants | 105 Participants |
| Age, Customized >= 65 years | 7 Participants | 1 Participants | 6 Participants | 6 Participants | 6 Participants | 3 Participants | 5 Participants | 2 Participants | 36 Participants |
| Sex: Female, Male Female | 33 Participants | 35 Participants | 35 Participants | 33 Participants | 38 Participants | 41 Participants | 34 Participants | 36 Participants | 285 Participants |
| Sex: Female, Male Male | 11 Participants | 10 Participants | 9 Participants | 11 Participants | 6 Participants | 4 Participants | 11 Participants | 9 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 45 | 5 / 44 | 1 / 44 | 1 / 44 | 2 / 45 | 6 / 45 | 7 / 45 | 6 / 44 |
| serious Total, serious adverse events | 0 / 45 | 1 / 44 | 0 / 44 | 1 / 44 | 0 / 45 | 1 / 45 | 0 / 45 | 0 / 44 |
Outcome results
Primary
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.
Time frame: Baseline, Day 28-hours 2 to 12
Population: Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AGN-199201 Dose A Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 12 | 13.3 Percentage of participants |
| AGN-199201 Dose A Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 2 | 13.3 Percentage of participants |
| AGN-199201 Dose A Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 4 | 17.8 Percentage of participants |
| AGN-199201 Dose A Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 6 | 17.8 Percentage of participants |
| AGN-199201 Dose A Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 10 | 17.8 Percentage of participants |
| AGN-199201 Dose A Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 8 | 15.6 Percentage of participants |
| AGN-199201 Dose B Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 6 | 22.7 Percentage of participants |
| AGN-199201 Dose B Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 2 | 20.5 Percentage of participants |
| AGN-199201 Dose B Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 8 | 20.5 Percentage of participants |
| AGN-199201 Dose B Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 12 | 13.6 Percentage of participants |
| AGN-199201 Dose B Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 4 | 31.8 Percentage of participants |
| AGN-199201 Dose B Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 10 | 20.5 Percentage of participants |
| AGN-199201 Dose C Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 10 | 13.6 Percentage of participants |
| AGN-199201 Dose C Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 6 | 13.6 Percentage of participants |
| AGN-199201 Dose C Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 4 | 27.3 Percentage of participants |
| AGN-199201 Dose C Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 8 | 20.5 Percentage of participants |
| AGN-199201 Dose C Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 12 | 13.6 Percentage of participants |
| AGN-199201 Dose C Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 2 | 22.7 Percentage of participants |
| AGN-199201 Vehicle Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 10 | 4.5 Percentage of participants |
| AGN-199201 Vehicle Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 2 | 6.8 Percentage of participants |
| AGN-199201 Vehicle Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 4 | 4.5 Percentage of participants |
| AGN-199201 Vehicle Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 6 | 4.5 Percentage of participants |
| AGN-199201 Vehicle Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 8 | 4.5 Percentage of participants |
| AGN-199201 Vehicle Once Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 12 | 2.3 Percentage of participants |
| AGN-199201 Dose A Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 10 | 13.3 Percentage of participants |
| AGN-199201 Dose A Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 4 | 11.1 Percentage of participants |
| AGN-199201 Dose A Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 12 | 13.3 Percentage of participants |
| AGN-199201 Dose A Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 2 | 8.9 Percentage of participants |
| AGN-199201 Dose A Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 8 | 8.9 Percentage of participants |
| AGN-199201 Dose A Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 6 | 11.1 Percentage of participants |
| AGN-199201 Dose B Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 6 | 13.3 Percentage of participants |
| AGN-199201 Dose B Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 8 | 20.0 Percentage of participants |
| AGN-199201 Dose B Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 4 | 20.0 Percentage of participants |
| AGN-199201 Dose B Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 10 | 15.6 Percentage of participants |
| AGN-199201 Dose B Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 2 | 17.8 Percentage of participants |
| AGN-199201 Dose B Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 12 | 11.1 Percentage of participants |
| AGN-199201 Dose C Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 8 | 20.0 Percentage of participants |
| AGN-199201 Dose C Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 10 | 26.7 Percentage of participants |
| AGN-199201 Dose C Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 2 | 15.6 Percentage of participants |
| AGN-199201 Dose C Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 6 | 24.4 Percentage of participants |
| AGN-199201 Dose C Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 12 | 15.6 Percentage of participants |
| AGN-199201 Dose C Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 4 | 22.2 Percentage of participants |
| AGN-199201 Vehicle Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 8 | 2.3 Percentage of participants |
| AGN-199201 Vehicle Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 6 | 4.5 Percentage of participants |
| AGN-199201 Vehicle Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 12 | 4.5 Percentage of participants |
| AGN-199201 Vehicle Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 10 | 2.3 Percentage of participants |
| AGN-199201 Vehicle Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 2 | 6.8 Percentage of participants |
| AGN-199201 Vehicle Twice Daily | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | Hour 4 | 6.8 Percentage of participants |
Secondary
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.
Time frame: Baseline, Day 28-hour 0.5
Population: Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN-199201 Dose A Once Daily | 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 | 6.7 Percentage of participants |
| AGN-199201 Dose B Once Daily | 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 | 11.4 Percentage of participants |
| AGN-199201 Dose C Once Daily | 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 | 6.8 Percentage of participants |
| AGN-199201 Vehicle Once Daily | 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 | 4.5 Percentage of participants |
| AGN-199201 Dose A Twice Daily | 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 | 6.7 Percentage of participants |
| AGN-199201 Dose B Twice Daily | 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 | 6.7 Percentage of participants |
| AGN-199201 Dose C Twice Daily | 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 | 6.7 Percentage of participants |
| AGN-199201 Vehicle Twice Daily | 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 | 2.3 Percentage of participants |
Secondary
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.
Time frame: Baseline, Day 28-hour 1
Population: Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN-199201 Dose A Once Daily | 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 | 11.1 Percentage of participants |
| AGN-199201 Dose B Once Daily | 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 | 13.6 Percentage of participants |
| AGN-199201 Dose C Once Daily | 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 | 18.2 Percentage of participants |
| AGN-199201 Vehicle Once Daily | 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 | 2.3 Percentage of participants |
| AGN-199201 Dose A Twice Daily | 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 | 6.7 Percentage of participants |
| AGN-199201 Dose B Twice Daily | 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 | 11.1 Percentage of participants |
| AGN-199201 Dose C Twice Daily | 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 | 8.9 Percentage of participants |
| AGN-199201 Vehicle Twice Daily | 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 | 2.3 Percentage of participants |