Trial Outcomes & Findings for AGN-199201 for the Treatment of Erythema With Rosacea (NCT NCT01735201)
NCT ID: NCT01735201
Last Updated: 2019-11-18
Results Overview
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.
COMPLETED
PHASE2
357 participants
Baseline, Day 28-hours 2 to 12
2019-11-18
Participant Flow
357 patients were randomized; 1 patient in error. 356 patients were included in the Modified intent-to-treat and Safety populations.
Participant milestones
| Measure |
AGN-199201 Dose A Once Daily
AGN-199201 Dose A applied once daily to the face for 28 days.
|
AGN-199201 Dose B Once Daily
AGN-199201 Dose B applied once daily to the face for 28 days.
|
AGN-199201 Dose C Once Daily
AGN-199201 Dose C applied once daily to the face for 28 days.
|
AGN-199201 Vehicle Once Daily
AGN-199201 Vehicle applied once daily to the face for 28 days.
|
AGN-199201 Dose A Twice Daily
AGN-199201 Dose A applied twice daily to the face for 28 days.
|
AGN-199201 Dose B Twice Daily
AGN-199201 Dose B applied twice daily to the face for 28 days.
|
AGN-199201 Dose C Twice Daily
AGN-199201 Dose C applied twice daily to the face for 28 days.
|
AGN-199201 Vehicle Twice Daily
AGN-199201 Vehicle applied twice daily to the face for 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
45
|
44
|
44
|
44
|
45
|
45
|
45
|
44
|
|
Overall Study
COMPLETED
|
42
|
43
|
44
|
42
|
44
|
40
|
42
|
42
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
0
|
2
|
1
|
5
|
3
|
2
|
Reasons for withdrawal
| Measure |
AGN-199201 Dose A Once Daily
AGN-199201 Dose A applied once daily to the face for 28 days.
|
AGN-199201 Dose B Once Daily
AGN-199201 Dose B applied once daily to the face for 28 days.
|
AGN-199201 Dose C Once Daily
AGN-199201 Dose C applied once daily to the face for 28 days.
|
AGN-199201 Vehicle Once Daily
AGN-199201 Vehicle applied once daily to the face for 28 days.
|
AGN-199201 Dose A Twice Daily
AGN-199201 Dose A applied twice daily to the face for 28 days.
|
AGN-199201 Dose B Twice Daily
AGN-199201 Dose B applied twice daily to the face for 28 days.
|
AGN-199201 Dose C Twice Daily
AGN-199201 Dose C applied twice daily to the face for 28 days.
|
AGN-199201 Vehicle Twice Daily
AGN-199201 Vehicle applied twice daily to the face for 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
1
|
1
|
3
|
2
|
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
|
|
Overall Study
Other Miscellaneous Reasons
|
0
|
0
|
0
|
1
|
0
|
2
|
1
|
1
|
Baseline Characteristics
AGN-199201 for the Treatment of Erythema With Rosacea
Baseline characteristics by cohort
| Measure |
AGN-199201 Dose A Once Daily
n=45 Participants
AGN-199201 Dose A applied once daily to the face for 28 days.
|
AGN-199201 Dose B Once Daily
n=44 Participants
AGN-199201 Dose B applied once daily to the face for 28 days.
|
AGN-199201 Dose C Once Daily
n=44 Participants
AGN-199201 Dose C applied once daily to the face for 28 days.
|
AGN-199201 Vehicle Once Daily
n=44 Participants
AGN-199201 Vehicle applied once daily to the face for 28 days.
|
AGN-199201 Dose A Twice Daily
n=45 Participants
AGN-199201 Dose A applied twice daily to the face for 28 days.
|
AGN-199201 Dose B Twice Daily
n=45 Participants
AGN-199201 Dose B applied twice daily to the face for 28 days.
|
AGN-199201 Dose C Twice Daily
n=45 Participants
AGN-199201 Dose C applied twice daily to the face for 28 days.
|
AGN-199201 Vehicle Twice Daily
n=44 Participants
AGN-199201 Vehicle applied twice daily to the face for 28 days.
|
Total
n=356 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
< 45 years
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
105 Participants
n=42 Participants
|
|
Age, Customized
45-64 years
|
30 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
28 Participants
n=24 Participants
|
215 Participants
n=42 Participants
|
|
Age, Customized
>= 65 years
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
36 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
34 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
33 Participants
n=24 Participants
|
285 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
71 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 28-hours 2 to 12Population: 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.
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.
Outcome measures
| Measure |
AGN-199201 Dose A Once Daily
n=45 Participants
AGN-199201 Dose A applied once daily to the face for 28 days.
|
AGN-199201 Dose B Once Daily
n=44 Participants
AGN-199201 Dose B applied once daily to the face for 28 days.
|
AGN-199201 Dose C Once Daily
n=44 Participants
AGN-199201 Dose C applied once daily to the face for 28 days.
|
AGN-199201 Vehicle Once Daily
n=44 Participants
AGN-199201 Vehicle applied once daily to the face for 28 days.
|
AGN-199201 Dose A Twice Daily
n=45 Participants
AGN-199201 Dose A applied twice daily to the face for 28 days.
|
AGN-199201 Dose B Twice Daily
n=45 Participants
AGN-199201 Dose B applied twice daily to the face for 28 days.
|
AGN-199201 Dose C Twice Daily
n=45 Participants
AGN-199201 Dose C applied twice daily to the face for 28 days.
|
AGN-199201 Vehicle Twice Daily
n=44 Participants
AGN-199201 Vehicle applied twice daily to the face for 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
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
|
20.5 Percentage of participants
|
22.7 Percentage of participants
|
6.8 Percentage of participants
|
8.9 Percentage of participants
|
17.8 Percentage of participants
|
15.6 Percentage of participants
|
6.8 Percentage of participants
|
|
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
|
22.7 Percentage of participants
|
13.6 Percentage of participants
|
4.5 Percentage of participants
|
11.1 Percentage of participants
|
13.3 Percentage of participants
|
24.4 Percentage of participants
|
4.5 Percentage of participants
|
|
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
|
20.5 Percentage of participants
|
20.5 Percentage of participants
|
4.5 Percentage of participants
|
8.9 Percentage of participants
|
20.0 Percentage of participants
|
20.0 Percentage of participants
|
2.3 Percentage of participants
|
|
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
|
31.8 Percentage of participants
|
27.3 Percentage of participants
|
4.5 Percentage of participants
|
11.1 Percentage of participants
|
20.0 Percentage of participants
|
22.2 Percentage of participants
|
6.8 Percentage of participants
|
|
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
|
20.5 Percentage of participants
|
13.6 Percentage of participants
|
4.5 Percentage of participants
|
13.3 Percentage of participants
|
15.6 Percentage of participants
|
26.7 Percentage of participants
|
2.3 Percentage of participants
|
|
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
|
13.6 Percentage of participants
|
13.6 Percentage of participants
|
2.3 Percentage of participants
|
13.3 Percentage of participants
|
11.1 Percentage of participants
|
15.6 Percentage of participants
|
4.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 28-hour 0.5Population: 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.
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.
Outcome measures
| Measure |
AGN-199201 Dose A Once Daily
n=45 Participants
AGN-199201 Dose A applied once daily to the face for 28 days.
|
AGN-199201 Dose B Once Daily
n=44 Participants
AGN-199201 Dose B applied once daily to the face for 28 days.
|
AGN-199201 Dose C Once Daily
n=44 Participants
AGN-199201 Dose C applied once daily to the face for 28 days.
|
AGN-199201 Vehicle Once Daily
n=44 Participants
AGN-199201 Vehicle applied once daily to the face for 28 days.
|
AGN-199201 Dose A Twice Daily
n=45 Participants
AGN-199201 Dose A applied twice daily to the face for 28 days.
|
AGN-199201 Dose B Twice Daily
n=45 Participants
AGN-199201 Dose B applied twice daily to the face for 28 days.
|
AGN-199201 Dose C Twice Daily
n=45 Participants
AGN-199201 Dose C applied twice daily to the face for 28 days.
|
AGN-199201 Vehicle Twice Daily
n=44 Participants
AGN-199201 Vehicle applied twice daily to the face for 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
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
|
11.4 Percentage of participants
|
6.8 Percentage of participants
|
4.5 Percentage of participants
|
6.7 Percentage of participants
|
6.7 Percentage of participants
|
6.7 Percentage of participants
|
2.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 28-hour 1Population: 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.
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.
Outcome measures
| Measure |
AGN-199201 Dose A Once Daily
n=45 Participants
AGN-199201 Dose A applied once daily to the face for 28 days.
|
AGN-199201 Dose B Once Daily
n=44 Participants
AGN-199201 Dose B applied once daily to the face for 28 days.
|
AGN-199201 Dose C Once Daily
n=44 Participants
AGN-199201 Dose C applied once daily to the face for 28 days.
|
AGN-199201 Vehicle Once Daily
n=44 Participants
AGN-199201 Vehicle applied once daily to the face for 28 days.
|
AGN-199201 Dose A Twice Daily
n=45 Participants
AGN-199201 Dose A applied twice daily to the face for 28 days.
|
AGN-199201 Dose B Twice Daily
n=45 Participants
AGN-199201 Dose B applied twice daily to the face for 28 days.
|
AGN-199201 Dose C Twice Daily
n=45 Participants
AGN-199201 Dose C applied twice daily to the face for 28 days.
|
AGN-199201 Vehicle Twice Daily
n=44 Participants
AGN-199201 Vehicle applied twice daily to the face for 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
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
|
13.6 Percentage of participants
|
18.2 Percentage of participants
|
2.3 Percentage of participants
|
6.7 Percentage of participants
|
11.1 Percentage of participants
|
8.9 Percentage of participants
|
2.3 Percentage of participants
|
Adverse Events
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
Serious adverse events
| Measure |
AGN-199201 Dose A Once Daily
n=45 participants at risk
AGN-199201 Dose A applied once daily to the face for 28 days.
|
AGN-199201 Dose B Once Daily
n=44 participants at risk
AGN-199201 Dose B applied once daily to the face for 28 days.
|
AGN-199201 Dose C Once Daily
n=44 participants at risk
AGN-199201 Dose C applied once daily to the face for 28 days.
|
AGN-199201 Vehicle Once Daily
n=44 participants at risk
AGN-199201 Vehicle applied once daily to the face for 28 days.
|
AGN-199201 Dose A Twice Daily
n=45 participants at risk
AGN-199201 Dose A applied twice daily to the face for 28 days.
|
AGN-199201 Dose B Twice Daily
n=45 participants at risk
AGN-199201 Dose B applied twice daily to the face for 28 days.
|
AGN-199201 Dose C Twice Daily
n=45 participants at risk
AGN-199201 Dose C applied twice daily to the face for 28 days.
|
AGN-199201 Vehicle Twice Daily
n=44 participants at risk
AGN-199201 Vehicle applied twice daily to the face for 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/45
|
0.00%
0/44
|
0.00%
0/44
|
2.3%
1/44
|
0.00%
0/45
|
0.00%
0/45
|
0.00%
0/45
|
0.00%
0/44
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/45
|
2.3%
1/44
|
0.00%
0/44
|
0.00%
0/44
|
0.00%
0/45
|
0.00%
0/45
|
0.00%
0/45
|
0.00%
0/44
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/45
|
0.00%
0/44
|
0.00%
0/44
|
2.3%
1/44
|
0.00%
0/45
|
0.00%
0/45
|
0.00%
0/45
|
0.00%
0/44
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/45
|
0.00%
0/44
|
0.00%
0/44
|
0.00%
0/44
|
0.00%
0/45
|
2.2%
1/45
|
0.00%
0/45
|
0.00%
0/44
|
|
Vascular disorders
Hypertension
|
0.00%
0/45
|
0.00%
0/44
|
0.00%
0/44
|
2.3%
1/44
|
0.00%
0/45
|
0.00%
0/45
|
0.00%
0/45
|
0.00%
0/44
|
Other adverse events
| Measure |
AGN-199201 Dose A Once Daily
n=45 participants at risk
AGN-199201 Dose A applied once daily to the face for 28 days.
|
AGN-199201 Dose B Once Daily
n=44 participants at risk
AGN-199201 Dose B applied once daily to the face for 28 days.
|
AGN-199201 Dose C Once Daily
n=44 participants at risk
AGN-199201 Dose C applied once daily to the face for 28 days.
|
AGN-199201 Vehicle Once Daily
n=44 participants at risk
AGN-199201 Vehicle applied once daily to the face for 28 days.
|
AGN-199201 Dose A Twice Daily
n=45 participants at risk
AGN-199201 Dose A applied twice daily to the face for 28 days.
|
AGN-199201 Dose B Twice Daily
n=45 participants at risk
AGN-199201 Dose B applied twice daily to the face for 28 days.
|
AGN-199201 Dose C Twice Daily
n=45 participants at risk
AGN-199201 Dose C applied twice daily to the face for 28 days.
|
AGN-199201 Vehicle Twice Daily
n=44 participants at risk
AGN-199201 Vehicle applied twice daily to the face for 28 days.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Application site dermatitis
|
0.00%
0/45
|
6.8%
3/44
|
0.00%
0/44
|
0.00%
0/44
|
2.2%
1/45
|
6.7%
3/45
|
4.4%
2/45
|
0.00%
0/44
|
|
General disorders
Application site acne
|
2.2%
1/45
|
2.3%
1/44
|
2.3%
1/44
|
0.00%
0/44
|
0.00%
0/45
|
0.00%
0/45
|
2.2%
1/45
|
6.8%
3/44
|
|
Nervous system disorders
Headache
|
8.9%
4/45
|
2.3%
1/44
|
0.00%
0/44
|
2.3%
1/44
|
2.2%
1/45
|
6.7%
3/45
|
8.9%
4/45
|
6.8%
3/44
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER