Trial Outcomes & Findings for Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea (NCT NCT02131636)
NCT ID: NCT02131636
Last Updated: 2019-11-18
Results Overview
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.
COMPLETED
PHASE3
440 participants
Baseline, Day 29 (Hours 3, 6, 9, and 12)
2019-11-18
Participant Flow
Participant milestones
| Measure |
AGN-199201
AGN-199201 applied to the face once daily for 29 days.
|
Vehicle
Vehicle to AGN-199201 applied to the face once daily for 29 days.
|
|---|---|---|
|
Overall Study
COMPLETED
|
210
|
213
|
|
Overall Study
NOT COMPLETED
|
12
|
5
|
|
Overall Study
STARTED
|
222
|
218
|
Reasons for withdrawal
| Measure |
AGN-199201
AGN-199201 applied to the face once daily for 29 days.
|
Vehicle
Vehicle to AGN-199201 applied to the face once daily for 29 days.
|
|---|---|---|
|
Overall Study
Personal Reasons
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
|
Overall Study
Adverse Event
|
4
|
1
|
Baseline Characteristics
Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea
Baseline characteristics by cohort
| Measure |
AGN-199201
n=222 Participants
AGN-199201 applied to the face once daily for 29 days.
|
Vehicle
n=218 Participants
Vehicle to AGN-199201 applied to the face once daily for 29 days.
|
Total
n=440 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 to 64 years
|
189 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
383 Participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
33 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
172 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
347 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 29 (Hours 3, 6, 9, and 12)Population: Intent-to-Treat: all randomized patients
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.
Outcome measures
| Measure |
AGN-199201
n=222 Participants
AGN-199201 applied to the face once daily for 29 days.
|
Vehicle
n=218 Participants
Vehicle to AGN-199201 applied to the face once daily for 29 days.
|
|---|---|---|
|
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
Day 29, Hour 9 (N=222, 216)
|
17.7 Percentage of Patients
|
6.0 Percentage of Patients
|
|
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
Day 29, Hour 12 (N=222, 216)
|
14.8 Percentage of Patients
|
6.0 Percentage of Patients
|
|
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
Day 29, Hour 3 (N=222, 216)
|
11.9 Percentage of Patients
|
5.5 Percentage of Patients
|
|
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
Day 29, Hour 6 (N=222, 216)
|
15.5 Percentage of Patients
|
8.3 Percentage of Patients
|
SECONDARY outcome
Timeframe: Baseline, Day 29 (Hours 3, 6, 9, and 12)Population: Intent-to-Treat: all randomized patients
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.
Outcome measures
| Measure |
AGN-199201
n=222 Participants
AGN-199201 applied to the face once daily for 29 days.
|
Vehicle
n=218 Participants
Vehicle to AGN-199201 applied to the face once daily for 29 days.
|
|---|---|---|
|
Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale
Day 29, Hour 3
|
20.1 Percentage of Patients
|
11.1 Percentage of Patients
|
|
Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale
Day 29, Hour 6
|
23.3 Percentage of Patients
|
12.9 Percentage of Patients
|
|
Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale
Day 29, Hour 9
|
23.3 Percentage of Patients
|
12.0 Percentage of Patients
|
|
Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale
Day 29, Hour 12
|
25.0 Percentage of Patients
|
11.5 Percentage of Patients
|
SECONDARY outcome
Timeframe: Baseline, Day 29 (Hours 3, 6, 9, and 12)Population: Intent-to-Treat: all randomized patients with data at the time point
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).
Outcome measures
| Measure |
AGN-199201
n=222 Participants
AGN-199201 applied to the face once daily for 29 days.
|
Vehicle
n=218 Participants
Vehicle to AGN-199201 applied to the face once daily for 29 days.
|
|---|---|---|
|
Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA)
Day 29, Hour 3
|
-21.37 Percent Change
Standard Deviation 94.693 • Interval -100.0 to 1097.0
|
61.54 Percent Change
Standard Deviation 428.943 • Interval -100.0 to 4699.1
|
|
Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA)
Day 29, Hour 6
|
-14.22 Percent Change
Standard Deviation 97.835 • Interval -100.0 to 750.3
|
75.09 Percent Change
Standard Deviation 498.844 • Interval -99.9 to 4668.5
|
|
Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA)
Day 29, Hour 9
|
-8.00 Percent Change
Standard Deviation 92.893 • Interval -100.0 to 1127.4
|
71.18 Percent Change
Standard Deviation 398.072 • Interval -98.9 to 3723.4
|
|
Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA)
Day 29, Hour 12
|
-5.35 Percent Change
Standard Deviation 98.547 • Interval -100.0 to 1211.9
|
74.16 Percent Change
Standard Deviation 415.301 • Interval -99.4 to 4894.8
|
SECONDARY outcome
Timeframe: Day 29 (Hours 3, 6, 9, and 12)Population: Intent-to-Treat: all randomized patients
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.
Outcome measures
| Measure |
AGN-199201
n=222 Participants
AGN-199201 applied to the face once daily for 29 days.
|
Vehicle
n=218 Participants
Vehicle to AGN-199201 applied to the face once daily for 29 days.
|
|---|---|---|
|
Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9
Day 29, Hour 3
|
45.9 Percentage of Patients
|
27.5 Percentage of Patients
|
|
Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9
Day 29, Hour 6
|
43.7 Percentage of Patients
|
24.3 Percentage of Patients
|
|
Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9
Day 29, Hour 9
|
43.2 Percentage of Patients
|
23.4 Percentage of Patients
|
|
Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9
Day 29, Hour 12
|
41.9 Percentage of Patients
|
24.8 Percentage of Patients
|
SECONDARY outcome
Timeframe: Baseline, Day 29 (Hours 3, 6, 9, and 12)Population: Intent-to-Treat: all randomized patients
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).
Outcome measures
| Measure |
AGN-199201
n=130 Participants
AGN-199201 applied to the face once daily for 29 days.
|
Vehicle
n=149 Participants
Vehicle to AGN-199201 applied to the face once daily for 29 days.
|
|---|---|---|
|
Change From Baseline on the SA-RFR Questionnaire Item #4
Baseline
|
1.8 Scores on a Scale
Standard Deviation 0.83
|
1.9 Scores on a Scale
Standard Deviation 0.85
|
|
Change From Baseline on the SA-RFR Questionnaire Item #4
Day 29, Hour 3
|
-1.5 Scores on a Scale
Standard Deviation 0.93
|
-1.5 Scores on a Scale
Standard Deviation 0.95
|
|
Change From Baseline on the SA-RFR Questionnaire Item #4
Day 29, Hour 6
|
-1.5 Scores on a Scale
Standard Deviation 0.91
|
-1.5 Scores on a Scale
Standard Deviation 0.98
|
|
Change From Baseline on the SA-RFR Questionnaire Item #4
Day 29, Hour 9
|
-1.5 Scores on a Scale
Standard Deviation 0.97
|
-1.5 Scores on a Scale
Standard Deviation 0.96
|
|
Change From Baseline on the SA-RFR Questionnaire Item #4
Day 29, Hour 12
|
-1.5 Scores on a Scale
Standard Deviation 0.97
|
-1.5 Scores on a Scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Baseline, Day 1 (Hour 1)Population: Intent-to-Treat: all randomized patients
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.
Outcome measures
| Measure |
AGN-199201
n=222 Participants
AGN-199201 applied to the face once daily for 29 days.
|
Vehicle
n=218 Participants
Vehicle to AGN-199201 applied to the face once daily for 29 days.
|
|---|---|---|
|
Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale
|
30.2 Percentage of Pateints
|
17.4 Percentage of Pateints
|
Adverse Events
AGN-199201
Vehicle
Serious adverse events
| Measure |
AGN-199201
n=222 participants at risk
AGN-199201 applied to the face once daily for 29 days.
|
Vehicle
n=218 participants at risk
Vehicle to AGN-199201 applied to the face once daily for 29 days.
|
|---|---|---|
|
General disorders
Fall
|
0.45%
1/222
|
0.00%
0/218
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/222
|
0.46%
1/218
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/222
|
0.46%
1/218
|
|
Cardiac disorders
Arteriosclerosis
|
0.00%
0/222
|
0.46%
1/218
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/222
|
0.46%
1/218
|
Other adverse events
Adverse event data not reported
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