Erythema, Rosacea
Conditions
Brief summary
This study will evaluate the safety and efficacy of AGN-199201 once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea.
Interventions
DRUGAGN-199201
AGN-199201 applied to the face once daily for 29 days.
DRUGVehicle to AGN-199201
Vehicle to AGN-199201 applied to the face once daily for 29 days.
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
-Moderate to severe persistent facial erythema associated with rosacea.
Exclusion criteria
* Greater than 3 inflammatory lesions on the face * Current treatment with monoamine oxidase (MAO) inhibitors * Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or Sjogren's syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, Day 29 (Hours 3, 6, 9, and 12) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale | Baseline, Day 29 (Hours 3, 6, 9, and 12) | 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. |
| Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA) | Baseline, Day 29 (Hours 3, 6, 9, and 12) | 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). |
| Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9 | Day 29 (Hours 3, 6, 9, and 12) | 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. |
| Change From Baseline on the SA-RFR Questionnaire Item #4 | Baseline, Day 29 (Hours 3, 6, 9, and 12) | 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). |
| Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale | Baseline, Day 1 (Hour 1) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AGN-199201 AGN-199201 applied to the face once daily for 29 days. | 222 |
| Vehicle Vehicle to AGN-199201 applied to the face once daily for 29 days. | 218 |
| Total | 440 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 1 |
| Overall Study | Lost to Follow-up | 4 | 0 |
| Overall Study | Personal Reasons | 4 | 4 |
Baseline characteristics
| Characteristic | AGN-199201 | Vehicle | Total |
|---|---|---|---|
| Age, Customized 18 to 64 years | 189 Participants | 194 Participants | 383 Participants |
| Age, Customized >=65 years | 33 Participants | 24 Participants | 57 Participants |
| Sex: Female, Male Female | 172 Participants | 175 Participants | 347 Participants |
| Sex: Female, Male Male | 50 Participants | 43 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 222 | 0 / 218 |
| serious Total, serious adverse events | 1 / 222 | 3 / 218 |
Outcome results
Primary
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
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.
Time frame: Baseline, Day 29 (Hours 3, 6, 9, and 12)
Population: Intent-to-Treat: all randomized patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AGN-199201 | 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 |
| AGN-199201 | 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 |
| AGN-199201 | 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 |
| AGN-199201 | 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 |
| Vehicle | 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) | 6.0 Percentage of Patients |
| Vehicle | 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) | 8.3 Percentage of Patients |
| Vehicle | 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) | 6.0 Percentage of Patients |
| Vehicle | 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) | 5.5 Percentage of Patients |
Secondary
Change From Baseline on the SA-RFR Questionnaire Item #4
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).
Time frame: Baseline, Day 29 (Hours 3, 6, 9, and 12)
Population: Intent-to-Treat: all randomized patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AGN-199201 | Change From Baseline on the SA-RFR Questionnaire Item #4 | Day 29, Hour 3 | -1.5 Scores on a Scale | Standard Deviation 0.93 |
| AGN-199201 | Change From Baseline on the SA-RFR Questionnaire Item #4 | Day 29, Hour 9 | -1.5 Scores on a Scale | Standard Deviation 0.97 |
| AGN-199201 | Change From Baseline on the SA-RFR Questionnaire Item #4 | Day 29, Hour 6 | -1.5 Scores on a Scale | Standard Deviation 0.91 |
| AGN-199201 | Change From Baseline on the SA-RFR Questionnaire Item #4 | Day 29, Hour 12 | -1.5 Scores on a Scale | Standard Deviation 0.97 |
| AGN-199201 | Change From Baseline on the SA-RFR Questionnaire Item #4 | Baseline | 1.8 Scores on a Scale | Standard Deviation 0.83 |
| Vehicle | Change From Baseline on the SA-RFR Questionnaire Item #4 | Day 29, Hour 12 | -1.5 Scores on a Scale | Standard Deviation 0.95 |
| Vehicle | Change From Baseline on the SA-RFR Questionnaire Item #4 | Baseline | 1.9 Scores on a Scale | Standard Deviation 0.85 |
| Vehicle | Change From Baseline on the SA-RFR Questionnaire Item #4 | Day 29, Hour 3 | -1.5 Scores on a Scale | Standard Deviation 0.95 |
| Vehicle | Change From Baseline on the SA-RFR Questionnaire Item #4 | Day 29, Hour 6 | -1.5 Scores on a Scale | Standard Deviation 0.98 |
| Vehicle | Change From Baseline on the SA-RFR Questionnaire Item #4 | Day 29, Hour 9 | -1.5 Scores on a Scale | Standard Deviation 0.96 |
Secondary
Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9
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.
Time frame: Day 29 (Hours 3, 6, 9, and 12)
Population: Intent-to-Treat: all randomized patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AGN-199201 | 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 |
| AGN-199201 | 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 |
| AGN-199201 | 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 |
| AGN-199201 | 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 |
| Vehicle | Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9 | Day 29, Hour 12 | 24.8 Percentage of Patients |
| Vehicle | Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9 | Day 29, Hour 3 | 27.5 Percentage of Patients |
| Vehicle | Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9 | Day 29, Hour 9 | 23.4 Percentage of Patients |
| Vehicle | Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9 | Day 29, Hour 6 | 24.3 Percentage of Patients |
Secondary
Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale
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.
Time frame: Baseline, Day 1 (Hour 1)
Population: Intent-to-Treat: all randomized patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AGN-199201 | Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale | 30.2 Percentage of Pateints |
| Vehicle | Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale | 17.4 Percentage of Pateints |
Secondary
Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale
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.
Time frame: Baseline, Day 29 (Hours 3, 6, 9, and 12)
Population: Intent-to-Treat: all randomized patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AGN-199201 | 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 |
| AGN-199201 | 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 |
| AGN-199201 | 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 |
| AGN-199201 | 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 |
| Vehicle | Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale | Day 29, Hour 12 | 11.5 Percentage of Patients |
| Vehicle | Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale | Day 29, Hour 3 | 11.1 Percentage of Patients |
| Vehicle | Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale | Day 29, Hour 9 | 12.0 Percentage of Patients |
| Vehicle | Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale | Day 29, Hour 6 | 12.9 Percentage of Patients |
Secondary
Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA)
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).
Time frame: Baseline, Day 29 (Hours 3, 6, 9, and 12)
Population: Intent-to-Treat: all randomized patients with data at the time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AGN-199201 | 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 |
| AGN-199201 | 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 |
| AGN-199201 | 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 |
| AGN-199201 | 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 |
| Vehicle | Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA) | Day 29, Hour 12 | 74.16 Percent Change | Standard Deviation 415.301 |
| Vehicle | Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA) | Day 29, Hour 3 | 61.54 Percent Change | Standard Deviation 428.943 |
| Vehicle | Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA) | Day 29, Hour 9 | 71.18 Percent Change | Standard Deviation 398.072 |
| Vehicle | Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA) | Day 29, Hour 6 | 75.09 Percent Change | Standard Deviation 498.844 |