Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN-199201 | Experimental | AGN-199201 applied to the face once daily for 29 days. |
|
| Vehicle | Placebo Comparator | Vehicle to AGN-199201 applied to the face once daily for 29 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-199201 | Drug | AGN-199201 applied to the face once daily for 29 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 29 (Hours 3, 6, 9, and 12) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
-Moderate to severe persistent facial erythema associated with rosacea.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lynchburg | Virginia | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AGN-199201 | AGN-199201 applied to the face once daily for 29 days. |
| FG001 | Vehicle | Vehicle to AGN-199201 applied to the face once daily for 29 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AGN-199201 | AGN-199201 applied to the face once daily for 29 days. |
| BG001 | Vehicle | Vehicle to AGN-199201 applied to the face once daily for 29 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent-to-Treat: all randomized patients | Posted | Number | Percentage of Patients | Baseline, Day 29 (Hours 3, 6, 9, and 12) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AGN-199201 | AGN-199201 applied to the face once daily for 29 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
Not provided
| ID | Term |
|---|---|
| D004890 | Erythema |
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vehicle to AGN-199201 |
| Drug |
Vehicle to AGN-199201 applied to the face once daily for 29 days. |
|
| Baseline, Day 29 (Hours 3, 6, 9, and 12) |
| 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). | Baseline, Day 29 (Hours 3, 6, 9, and 12) |
| 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. | Day 29 (Hours 3, 6, 9, and 12) |
| 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). | Baseline, Day 29 (Hours 3, 6, 9, and 12) |
| 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. | Baseline, Day 1 (Hour 1) |
| Adverse Event |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
AGN-199201 applied to the face once daily for 29 days. |
| OG001 | Vehicle | Vehicle to AGN-199201 applied to the face once daily for 29 days. |
|
|
| 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. | Intent-to-Treat: all randomized patients | Posted | Number | Percentage of Patients | Baseline, Day 29 (Hours 3, 6, 9, and 12) |
|
|
|
| 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). | Intent-to-Treat: all randomized patients with data at the time point | Posted | Mean | Standard Deviation | Percent Change | Baseline, Day 29 (Hours 3, 6, 9, and 12) |
|
|
|
| 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. | Intent-to-Treat: all randomized patients | Posted | Number | Percentage of Patients | Day 29 (Hours 3, 6, 9, and 12) |
|
|
|
| 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). | Intent-to-Treat: all randomized patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Day 29 (Hours 3, 6, 9, and 12) |
|
|
|
| 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. | Intent-to-Treat: all randomized patients | Posted | Number | Percentage of Pateints | Baseline, Day 1 (Hour 1) |
|
|
|
| 1 |
| 222 |
| 0 |
| 222 |
| EG001 | Vehicle | Vehicle to AGN-199201 applied to the face once daily for 29 days. | 3 | 218 | 0 | 218 |
| Atrial Fibrillation | Cardiac disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Arteriosclerosis | Cardiac disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
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.
| D013568 | Pathological Conditions, Signs and Symptoms |
| Day 29, Hour 9 |
|
| Day 29, Hour 12 |
|
| Day 29, Hour 9 |
|
| Day 29, Hour 12 |
|
| Day 29, Hour 9 |
|
| Day 29, Hour 12 |
|
| Day 29, Hour 6 |
|
| Day 29, Hour 9 |
|
| Day 29, Hour 12 |
|