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This study will evaluate the safety and efficacy of oxymetazoline hydrochloride (HCl) cream 1.0% (AGN-199201) once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxymetazoline HCL Cream 1.0% | Experimental | Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days. |
|
| Vehicle | Placebo Comparator | Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxymetazoline HCL Cream 1.0% | Drug | Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 29 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment for Rosacea Facial Redness (SSA) 5-point Scales | The investigator assessed the participant's overall severity of erythema in the treatment area by using the 5-point CEA scale with photonumeric guide where: 0=clear skin with no signs of erythema (best) to 4=severe erythema; fiery redness (worst). A decrease in the score indicates improvement. The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants 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) post-dose on Day 29. Baseline was defined as the measurement at pre-dose on Day 1. | Baseline, Day 29 (Hours 3, 6, 9 and 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on SSA at Hours 3, 6, 9 and 12 on Day 29 | The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants with at least a 2-grade decrease (improvement) on SSA from Baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) post-dose on Day 29. |
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Inclusion Criteria:
-Moderate to severe persistent facial erythema associated with rosacea.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College Station | Texas | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxymetazoline HCL Cream 1.0% | Oxymetazoline hydrochloride (HCL) Cream 1.0% applied to the face once daily for 29 days. |
| FG001 | Vehicle | Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxymetazoline HCL Cream 1.0% | Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days. |
| BG001 | Vehicle | Vehicle to Oxymetazoline HCL Cream 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 Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment for Rosacea Facial Redness (SSA) 5-point Scales | The investigator assessed the participant's overall severity of erythema in the treatment area by using the 5-point CEA scale with photonumeric guide where: 0=clear skin with no signs of erythema (best) to 4=severe erythema; fiery redness (worst). A decrease in the score indicates improvement. The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants 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) post-dose on Day 29. Baseline was defined as the measurement at pre-dose on Day 1. | Intent-to-treat (ITT) Population included all randomized participants. | Posted | Number | percentage of participants | Baseline, Day 29 (Hours 3, 6, 9 and 12) |
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Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
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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 | Oxymetazoline HCL Cream 1.0% | Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Goitre | Endocrine disorders | MedDRA 18.0 | 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 |
|---|---|
| D004890 | Erythema |
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| Vehicle to Oxymetazoline HCL Cream | Drug | Vehicle to Oxymetazoline HCL Cream (AGN-199201) applied to the face once daily for 29 days. |
|
| Baseline, Day 29 (Hours 3, 6, 9 and 12) |
| Percent Change From Baseline on Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA) at Hours 3, 6, 9 and 12 on Day 29 | DIA of photographs was used to assess rosacea facial redness and was defined as percentage of facial area occupied by redness. A higher value in the percentage of facial area occupied by facial redness indicated more redness. A negative/ lower number percent change from Baseline indicates improvement. | Baseline, Day 29 (Hours 3, 6, 9 and 12) |
| Percentage of Participants Satisfied or Very Satisfied on Item #9 of Satisfaction Assessment for Rosacea Facial Redness (SAT-RFR) at Hours 3, 6, 9 and 12 on Day 29 | Participants assessed their treatment satisfaction by answering Item #9 of the SAT-RFR: "Right now, how satisfied are you with the effect your study medication had on your facial redness?" using a 5-point scale where 0= very dissatisfied, 1=dissatisfied, 2=neither satisfied or dissatisfied, 3=satisfied, or 4=very satisfied. The percentage of participants who answered Satisfied or Very Satisfied is reported. | Day 29 (Hours 3, 6, 9 and 12) |
| Change From Baseline on the Symptom Assessment for Rosacea Facial Redness (SA-RFR) Item # 4 at Hours 3, 6, 9 and 12 on Day 29 | Participants assessed the burning sensation associated with rosacea facial redness by answering Item #4 of the SA-RFR: "Right now, how much does your face burn because of your facial redness?" using a 5-point scale where 0=less severe to 4=severe. A negative change from Baseline indicates improvement. | Baseline, Day 29 (Hours 3, 6, 9 and 12) |
| Percentage of Participants With at Least a 1-Grade Improvement (Decrease) From Baseline on SSA at Hour 1 on Day 1 | The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. | Baseline, Day 1 (Hour 1) |
| Personal Reasons |
|
| Other Miscellaneous Reasons |
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Oxymetazoline HCL Cream 1.0% | Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days. |
| OG001 | Vehicle | Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days. |
|
|
| Secondary | Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on SSA at Hours 3, 6, 9 and 12 on Day 29 | The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants with at least a 2-grade decrease (improvement) on SSA from Baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) post-dose on Day 29. | ITT Population included all randomized participants. | Posted | Number | percentage of participants | Baseline, Day 29 (Hours 3, 6, 9 and 12) |
|
|
|
| Secondary | Percent Change From Baseline on Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA) at Hours 3, 6, 9 and 12 on Day 29 | DIA of photographs was used to assess rosacea facial redness and was defined as percentage of facial area occupied by redness. A higher value in the percentage of facial area occupied by facial redness indicated more redness. A negative/ lower number percent change from Baseline indicates improvement. | ITT Population included all randomized participants. | Posted | Median | Full Range | percent change in area of redness | Baseline, Day 29 (Hours 3, 6, 9 and 12) |
|
|
|
| Secondary | Percentage of Participants Satisfied or Very Satisfied on Item #9 of Satisfaction Assessment for Rosacea Facial Redness (SAT-RFR) at Hours 3, 6, 9 and 12 on Day 29 | Participants assessed their treatment satisfaction by answering Item #9 of the SAT-RFR: "Right now, how satisfied are you with the effect your study medication had on your facial redness?" using a 5-point scale where 0= very dissatisfied, 1=dissatisfied, 2=neither satisfied or dissatisfied, 3=satisfied, or 4=very satisfied. The percentage of participants who answered Satisfied or Very Satisfied is reported. | Participants from the ITT Population, all randomized participants with data available for analysis. | Posted | Number | percentage of participants | Day 29 (Hours 3, 6, 9 and 12) |
|
|
|
| Secondary | Change From Baseline on the Symptom Assessment for Rosacea Facial Redness (SA-RFR) Item # 4 at Hours 3, 6, 9 and 12 on Day 29 | Participants assessed the burning sensation associated with rosacea facial redness by answering Item #4 of the SA-RFR: "Right now, how much does your face burn because of your facial redness?" using a 5-point scale where 0=less severe to 4=severe. A negative change from Baseline indicates improvement. | Participants from the ITT Population, all randomized participants, with data available for analysis at the given time-point. Only participants who had a SA-RFR score of 1-4 at Baseline are included in the Analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 29 (Hours 3, 6, 9 and 12) |
|
|
|
| Secondary | Percentage of Participants With at Least a 1-Grade Improvement (Decrease) From Baseline on SSA at Hour 1 on Day 1 | The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. | ITT Population included all randomized participants. | Posted | Number | percentage of participants | Baseline, Day 1 (Hour 1) |
|
|
|
| 3 |
| 223 |
| 0 |
| 223 |
| EG001 | Vehicle | Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days. | 2 | 221 | 0 | 221 |
| Hyperparathyroidism | Endocrine disorders | MedDRA 18.0 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Traumatic liver injury | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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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 |
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