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This study will evaluate the safety and tolerability of AGN-199201 for the treatment of erythema associated with rosacea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN-199201 Formulation A and B | Experimental | AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily. |
|
| AGN-199201 Formulation B and C | Experimental | AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily. |
|
| AGN-199201 Formulation C and A | Experimental | AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily. |
|
| AGN-199201 Formulation A and Vehicle | Other | AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily. |
|
| AGN-199201 Formulation B and Vehicle | Other | AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-199201 Formulation A | Drug | AGN-199201 Formulation A applied to the face as per protocol twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1 | The percentage of responders was determined by facial sides 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 at Day 1. 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 1-hour 6 |
| Percentage of Responders With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 5 | The percentage of responders was determined by facial sides 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 at Day 5. 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 5-hour 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA | The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score at Day 1 and Day 5. 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. |
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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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | AGN-199201 Formulation A and B | AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily for 5 days. |
| FG001 | AGN-199201 Formulation B and C | AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days. |
| FG002 | AGN-199201 Formulation C and A | AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days. |
| FG003 | AGN-199201 Formulation A and Vehicle | AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days. |
| FG004 | AGN-199201 Formulation B and Vehicle | AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days. |
| FG005 | AGN-199201 Formulation C and Vehicle | AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days. |
| FG006 | AGN-199201 Formulation A | AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days. |
| FG007 | AGN-199201 Formulation B | AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days. |
| FG008 | AGN-199201 Formulation C | AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days. |
| FG009 | AGN-199201 Vehicle | AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AGN-199201 Formulation A and B | AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily for 5 days. |
| BG001 | AGN-199201 Formulation B and C |
| 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 Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1 | The percentage of responders was determined by facial sides 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 at Day 1. 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 consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA. | Posted | Number | Percentage of responders | Baseline, Day 1-hour 6 | Facial Sides | Facial Sides |
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Serious Adverse Events and Adverse Events are reported by treatment arm not necessarily by individual intervention (treatment) received.
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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 Formulation A and B | AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily for 5 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pruritus | Eye disorders | MedDRA (15.0) | 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 Formulation C and Vehicle | Other | AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily. |
|
| AGN-199201 Formulation A | Experimental | AGN-199201 Formulation A applied to both sides of the face twice daily. |
|
| AGN-199201 Formulation B | Experimental | AGN-199201 Formulation B applied to both sides of the face twice daily. |
|
| AGN-199201 Formulation C | Experimental | AGN-199201 Formulation C applied to both sides of the face twice daily. |
|
| AGN-199201 Vehicle | Placebo Comparator | AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily. |
|
| AGN-199201 Formulation B | Drug | AGN-199201 Formulation B applied to the face as per protocol twice daily. |
|
| AGN-199201 Formulation C | Drug | AGN-199201 Formulation C applied to the face as per protocol twice daily. |
|
| AGN-199201 Vehicle | Drug | AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily. |
|
| Baseline, Day 1-hour 6, Day 5-hour 6 |
| Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA | The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 1 and Day 5. 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, Day1-hour 6, Day 5-hour 6 |
AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days.
| BG002 | AGN-199201 Formulation C and A | AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days. |
| BG003 | AGN-199201 Formulation A and Vehicle | AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days. |
| BG004 | AGN-199201 Formulation B and Vehicle | AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days. |
| BG005 | AGN-199201 Formulation C and Vehicle | AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days. |
| BG006 | AGN-199201 Formulation A | AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days. |
| BG007 | AGN-199201 Formulation B | AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days. |
| BG008 | AGN-199201 Formulation C | AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days. |
| BG009 | AGN-199201 Vehicle | AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days. |
| BG010 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | AGN-199201 Formulation A | AGN-199201 Formulation A applied to the face twice daily for 5 days. Includes participants treated with Formulation A in any of the randomized treatment groups. |
| OG001 | AGN-199201 Formulation B | AGN-199201 Formulation B applied to the face twice daily for 5 days. Includes participants treated with Formulation B in any of the randomized treatment groups. |
| OG002 | AGN-199201 Formulation C | AGN-199201 Formulation C applied to the face twice daily for 5 days. Includes participants treated with Formulation C in any of the randomized treatment groups. |
| OG003 | AGN-199201 Vehicle | AGN-199201 Vehicle (Placebo) applied to the face twice daily for 5 days. Includes participants treated with Vehicle in any of the randomized treatment groups. |
|
|
| Secondary | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA | The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score at Day 1 and Day 5. 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. | Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA. | Posted | Number | Percentage of responders | Baseline, Day 1-hour 6, Day 5-hour 6 | Facial sides | Facial sides |
|
|
|
| Secondary | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA | The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 1 and Day 5. 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 consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA. | Posted | Number | Percentage of responders | Baseline, Day1-hour 6, Day 5-hour 6 | Facial sides | Facial sides |
|
|
|
| Primary | Percentage of Responders With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 5 | The percentage of responders was determined by facial sides 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 at Day 5. 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 consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA. | Posted | Number | Percentage of responders | Baseline, Day 5-hour 6 | Facial sides | Facial sides |
|
|
|
| 0 |
| 8 |
| 3 |
| 8 |
| EG001 | AGN-199201 Formulation B and C | AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days. | 0 | 8 | 5 | 8 |
| EG002 | AGN-199201 Formulation C and A | AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days. | 0 | 8 | 3 | 8 |
| EG003 | AGN-199201 Formulation A and Vehicle | AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days. | 0 | 8 | 6 | 8 |
| EG004 | AGN-199201 Formulation B and Vehicle | AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days. | 0 | 8 | 6 | 8 |
| EG005 | AGN-199201 Formulation C and Vehicle | AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days. | 0 | 8 | 4 | 8 |
| EG006 | AGN-199201 Formulation A | AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days. | 0 | 4 | 3 | 4 |
| EG007 | AGN-199201 Formulation B | AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days. | 0 | 4 | 3 | 4 |
| EG008 | AGN-199201 Formulation C | AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days. | 0 | 4 | 3 | 4 |
| EG009 | AGN-199201 Vehicle | AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days. | 0 | 4 | 2 | 4 |
| Lip dry | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Application site anaesthesia | General disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Application site dryness | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Application site erosion | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Application site erythema | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Application site exfoliation | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Application site nodule | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Application site pain | General disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Application site papules | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Application site paraesthesia | General disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Application site rash | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Application site warmth | General disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Application site pustules | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Infected bites | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Vaginitis bacterial | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Skin tightness | Skin and subcutaneous tissue disorders | MedDRA (15.0) | 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 |
| Facial sides |
|
| Day 5-hour 6 (Facial Sides n=32,31,31,32) |
|
| Facial sides |
|
| Day 5-hour 6 (Facial Sides n=32,31,31,32) |
|
| Facial sides |
|