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This study will evaluate the safety and efficacy of 3 doses of AGN-199201 once and twice daily compared to vehicle for the treatment of moderate to severe facial erythema associated with rosacea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN-199201 Dose A Once Daily | Experimental | AGN-199201 Dose A applied once daily to the face for 28 days. |
|
| AGN-199201 Dose B Once Daily | Experimental | AGN-199201 Dose B applied once daily to the face for 28 days. |
|
| AGN-199201 Dose C Once Daily | Experimental | AGN-199201 Dose C applied once daily to the face for 28 days. |
|
| AGN-199201 Vehicle Once Daily | Placebo Comparator | AGN-199201 Vehicle applied once daily to the face for 28 days. |
|
| AGN-199201 Dose A Twice Daily | Experimental | AGN-199201 Dose A applied twice daily to the face for 28 days. |
|
| AGN-199201 Dose B Twice Daily | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-199201 Dose A | Drug | AGN-199201 Dose A applied once or twice daily to the face for 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (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. | Baseline, Day 28-hours 2 to 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin | Texas | United States |
357 patients were randomized; 1 patient in error. 356 patients were included in the Modified intent-to-treat and Safety populations.
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| ID | Title | Description |
|---|---|---|
| FG000 | AGN-199201 Dose A Once Daily | AGN-199201 Dose A applied once daily to the face for 28 days. |
| FG001 | AGN-199201 Dose B Once Daily | AGN-199201 Dose B applied once daily to the face for 28 days. |
| FG002 | AGN-199201 Dose C Once Daily | AGN-199201 Dose C applied once daily to the face for 28 days. |
| FG003 | AGN-199201 Vehicle Once Daily | AGN-199201 Vehicle applied once daily to the face for 28 days. |
| FG004 | AGN-199201 Dose A Twice Daily | AGN-199201 Dose A applied twice daily to the face for 28 days. |
| FG005 | AGN-199201 Dose B Twice Daily | AGN-199201 Dose B applied twice daily to the face for 28 days. |
| FG006 | AGN-199201 Dose C Twice Daily | AGN-199201 Dose C applied twice daily to the face for 28 days. |
| FG007 | AGN-199201 Vehicle Twice Daily | AGN-199201 Vehicle applied twice daily to the face for 28 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AGN-199201 Dose A Once Daily | AGN-199201 Dose A applied once daily to the face for 28 days. |
| BG001 | AGN-199201 Dose B Once Daily | AGN-199201 Dose B applied once daily to the face for 28 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 Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (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. | 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. | Posted | Number | Percentage of participants | Baseline, Day 28-hours 2 to 12 |
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| 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 Dose A Once Daily | AGN-199201 Dose A applied once daily to the face for 28 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA 16.0 | Systematic Assessment | Event not related to study treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site dermatitis | General disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| D004890 | Erythema |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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AGN-199201 Dose B applied twice daily to the face for 28 days.
|
| AGN-199201 Dose C Twice Daily | Experimental | AGN-199201 Dose C applied twice daily to the face for 28 days. |
|
| AGN-199201 Vehicle Twice Daily | Placebo Comparator | AGN-199201 Vehicle applied twice daily to the face for 28 days. |
|
| AGN-199201 Dose B | Drug | AGN-199201 Dose B applied once or twice daily to the face for 28 days. |
|
| AGN-199201 Dose C | Drug | AGN-199201 Dose C applied once or twice daily to the face for 28 days. |
|
| AGN-199201 Vehicle | Drug | AGN-199201 Vehicle applied once or twice daily to the face for 28 days. |
|
| Baseline, Day 28-hour 0.5 |
| 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 | 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. | Baseline, Day 28-hour 1 |
| Personal Reasons |
|
| Protocol Violation |
|
| Other Miscellaneous Reasons |
|
| BG002 | AGN-199201 Dose C Once Daily | AGN-199201 Dose C applied once daily to the face for 28 days. |
| BG003 | AGN-199201 Vehicle Once Daily | AGN-199201 Vehicle applied once daily to the face for 28 days. |
| BG004 | AGN-199201 Dose A Twice Daily | AGN-199201 Dose A applied twice daily to the face for 28 days. |
| BG005 | AGN-199201 Dose B Twice Daily | AGN-199201 Dose B applied twice daily to the face for 28 days. |
| BG006 | AGN-199201 Dose C Twice Daily | AGN-199201 Dose C applied twice daily to the face for 28 days. |
| BG007 | AGN-199201 Vehicle Twice Daily | AGN-199201 Vehicle applied twice daily to the face for 28 days. |
| BG008 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | AGN-199201 Dose A Once Daily | AGN-199201 Dose A applied once daily to the face for 28 days. |
| OG001 | AGN-199201 Dose B Once Daily | AGN-199201 Dose B applied once daily to the face for 28 days. |
| OG002 | AGN-199201 Dose C Once Daily | AGN-199201 Dose C applied once daily to the face for 28 days. |
| OG003 | AGN-199201 Vehicle Once Daily | AGN-199201 Vehicle applied once daily to the face for 28 days. |
| OG004 | AGN-199201 Dose A Twice Daily | AGN-199201 Dose A applied twice daily to the face for 28 days. |
| OG005 | AGN-199201 Dose B Twice Daily | AGN-199201 Dose B applied twice daily to the face for 28 days. |
| OG006 | AGN-199201 Dose C Twice Daily | AGN-199201 Dose C applied twice daily to the face for 28 days. |
| OG007 | AGN-199201 Vehicle Twice Daily | AGN-199201 Vehicle applied twice daily to the face for 28 days. |
|
|
| Secondary | 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 | 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. | 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. | Posted | Number | Percentage of participants | Baseline, Day 28-hour 0.5 |
|
|
|
| Secondary | 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 | 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. | 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. | Posted | Number | Percentage of participants | Baseline, Day 28-hour 1 |
|
|
|
| 0 |
| 45 |
| 5 |
| 45 |
| EG001 | AGN-199201 Dose B Once Daily | AGN-199201 Dose B applied once daily to the face for 28 days. | 1 | 44 | 5 | 44 |
| EG002 | AGN-199201 Dose C Once Daily | AGN-199201 Dose C applied once daily to the face for 28 days. | 0 | 44 | 1 | 44 |
| EG003 | AGN-199201 Vehicle Once Daily | AGN-199201 Vehicle applied once daily to the face for 28 days. | 1 | 44 | 1 | 44 |
| EG004 | AGN-199201 Dose A Twice Daily | AGN-199201 Dose A applied twice daily to the face for 28 days. | 0 | 45 | 2 | 45 |
| EG005 | AGN-199201 Dose B Twice Daily | AGN-199201 Dose B applied twice daily to the face for 28 days. | 1 | 45 | 6 | 45 |
| EG006 | AGN-199201 Dose C Twice Daily | AGN-199201 Dose C applied twice daily to the face for 28 days. | 0 | 45 | 7 | 45 |
| EG007 | AGN-199201 Vehicle Twice Daily | AGN-199201 Vehicle applied twice daily to the face for 28 days. | 0 | 44 | 6 | 44 |
|
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment | Event not related to study treatment. |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment | Event not related to study treatment. |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 16.0 | Systematic Assessment | Event not related to study treatment. |
|
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment | Event not related to study treatment. |
|
| Application site acne | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Non-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 |