Erythema, Rosacea
Conditions
Brief summary
This study will evaluate the safety and tolerability of AGN-199201 for the treatment of erythema associated with rosacea.
Interventions
DRUGAGN-199201 Formulation A
AGN-199201 Formulation A applied to the face as per protocol twice daily.
DRUGAGN-199201 Formulation B
AGN-199201 Formulation B applied to the face as per protocol twice daily.
DRUGAGN-199201 Formulation C
AGN-199201 Formulation C applied to the face as per protocol twice daily.
AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* facial erythema associated with rosacea on both sides of the face
Exclusion criteria
* Laser light-source or other energy based therapy in the last 6 months * Excessive hair around the treatment area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1 | Baseline, Day 1-hour 6 | The percentage of responders was determined by facial sides 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 at Day 1. 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 Responders With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 5 | Baseline, Day 5-hour 6 | The percentage of responders was determined by facial sides 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 at Day 5. 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 Responders With at Least a 2-Grade Decrease From Baseline on CEA | Baseline, Day 1-hour 6, Day 5-hour 6 | The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score at Day 1 and Day 5. 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. |
| Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA | Baseline, Day1-hour 6, Day 5-hour 6 | The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 1 and Day 5. 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
Participants by arm
| Arm | Count |
|---|---|
| AGN-199201 Formulation A and B AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily for 5 days. | 8 |
| AGN-199201 Formulation B and C AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days. | 8 |
| AGN-199201 Formulation C and A AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days. | 8 |
| AGN-199201 Formulation A and Vehicle AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days. | 8 |
| AGN-199201 Formulation B and Vehicle AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days. | 8 |
| AGN-199201 Formulation C and Vehicle AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days. | 8 |
| AGN-199201 Formulation A AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days. | 4 |
| AGN-199201 Formulation B AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days. | 4 |
| AGN-199201 Formulation C AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days. | 4 |
| AGN-199201 Vehicle AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days. | 4 |
| Total | 64 |
Baseline characteristics
| Characteristic | Total | AGN-199201 Formulation A and B | AGN-199201 Formulation B and C | AGN-199201 Formulation C and A | AGN-199201 Formulation A and Vehicle | AGN-199201 Formulation B and Vehicle | AGN-199201 Formulation C and Vehicle | AGN-199201 Formulation A | AGN-199201 Formulation B | AGN-199201 Formulation C | AGN-199201 Vehicle |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized 45 to 65 years | 50 Participants | 7 Participants | 6 Participants | 6 Participants | 4 Participants | 8 Participants | 7 Participants | 3 Participants | 3 Participants | 2 Participants | 4 Participants |
| Age, Customized < 45 years | 10 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Age, Customized > 65 years | 4 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Female | 49 Participants | 5 Participants | 8 Participants | 6 Participants | 7 Participants | 5 Participants | 7 Participants | 2 Participants | 4 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 15 Participants | 3 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 1 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 | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 8 | 5 / 8 | 3 / 8 | 6 / 8 | 6 / 8 | 4 / 8 | 3 / 4 | 3 / 4 | 3 / 4 | 2 / 4 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 |
Outcome results
Primary
Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1
The percentage of responders was determined by facial sides 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 at Day 1. 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 1-hour 6
Population: Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN-199201 Formulation A | Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1 | 15.6 Percentage of responders |
| AGN-199201 Formulation B | Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1 | 21.9 Percentage of responders |
| AGN-199201 Formulation C | Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1 | 28.1 Percentage of responders |
| AGN-199201 Vehicle | Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1 | 0.0 Percentage of responders |
Primary
Percentage of Responders With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 5
The percentage of responders was determined by facial sides 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 at Day 5. 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 5-hour 6
Population: Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN-199201 Formulation A | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 5 | 6.3 Percentage of responders |
| AGN-199201 Formulation B | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 5 | 6.5 Percentage of responders |
| AGN-199201 Formulation C | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 5 | 6.5 Percentage of responders |
| AGN-199201 Vehicle | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 5 | 3.1 Percentage of responders |
Secondary
Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA
The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score at Day 1 and Day 5. 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.
Time frame: Baseline, Day 1-hour 6, Day 5-hour 6
Population: Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AGN-199201 Formulation A | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA | Day 1-hour 6 | 34.4 Percentage of responders |
| AGN-199201 Formulation A | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA | Day 5-hour 6 (Facial Sides n=32,31,31,32) | 15.6 Percentage of responders |
| AGN-199201 Formulation B | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA | Day 5-hour 6 (Facial Sides n=32,31,31,32) | 6.5 Percentage of responders |
| AGN-199201 Formulation B | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA | Day 1-hour 6 | 34.4 Percentage of responders |
| AGN-199201 Formulation C | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA | Day 1-hour 6 | 40.6 Percentage of responders |
| AGN-199201 Formulation C | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA | Day 5-hour 6 (Facial Sides n=32,31,31,32) | 6.5 Percentage of responders |
| AGN-199201 Vehicle | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA | Day 1-hour 6 | 0.0 Percentage of responders |
| AGN-199201 Vehicle | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA | Day 5-hour 6 (Facial Sides n=32,31,31,32) | 6.3 Percentage of responders |
Secondary
Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA
The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 1 and Day 5. 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, Day1-hour 6, Day 5-hour 6
Population: Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AGN-199201 Formulation A | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA | Day1-hour 6 | 31.3 Percentage of responders |
| AGN-199201 Formulation A | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA | Day 5-hour 6 (Facial Sides n=32,31,31,32) | 34.4 Percentage of responders |
| AGN-199201 Formulation B | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA | Day 5-hour 6 (Facial Sides n=32,31,31,32) | 41.9 Percentage of responders |
| AGN-199201 Formulation B | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA | Day1-hour 6 | 46.9 Percentage of responders |
| AGN-199201 Formulation C | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA | Day1-hour 6 | 56.3 Percentage of responders |
| AGN-199201 Formulation C | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA | Day 5-hour 6 (Facial Sides n=32,31,31,32) | 58.1 Percentage of responders |
| AGN-199201 Vehicle | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA | Day1-hour 6 | 3.1 Percentage of responders |
| AGN-199201 Vehicle | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA | Day 5-hour 6 (Facial Sides n=32,31,31,32) | 28.1 Percentage of responders |