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This study will evaluate the long-term safety and efficacy of oxymetazoline hydrogen chloride (HCL) Cream 1.0% (AGN-199201) in patients with persistent erythema associated with rosacea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxymetazoline HCL Cream 1.0% | Experimental | Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxymetazoline HCL Cream 1.0% | Drug | Oxymetazoline HCL Cream 1.0% applied to the face once daily for 52 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-Related Adverse Events | An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A Treatment-Related Adverse Event is an Adverse Event determined by the investigator to be causally related to the study medication. | 56 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 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 6-hour evaluation period (hours 3 and 6) post-dose. |
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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 |
|---|---|---|---|---|---|---|
| Portland | Oregon | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxymetazoline HCL Cream 1.0% | Oxymetazoline hydrogen chloride (HCL) Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks. |
| 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% (AGN-199201) applied to the face once daily for 52 weeks. |
| 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 Treatment-Related Adverse Events | An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A Treatment-Related Adverse Event is an Adverse Event determined by the investigator to be causally related to the study medication. | Safety population included all participants who received at least 1 dose of study medication. | Posted | Number | percentage of participants | 56 Weeks |
|
Up to 56 Weeks
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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% (AGN-199201) applied to the face once daily for 52 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac 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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| Baseline, Day 1 Hours 3 and 6, Week 4 Predose and Hours 3 and 6, Week 12 Predose, Week 26 Predose and Hours 3 and 6, Week 39 Predose, Week 52 Predose and Hours 3 and 6, Week 54 Predose |
| Lost to Follow-up |
|
| Personal Reasons |
|
| Protocol Violation |
|
| Other Miscellaneous Reasons |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 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 6-hour evaluation period (hours 3 and 6) post-dose. | Modified-intent-to-treat (mITT) population consisted of all participants who had at least 1 post-baseline CEA and SSA measurement. | Posted | Number | percentage of participants | Baseline, Day 1 Hours 3 and 6, Week 4 Predose and Hours 3 and 6, Week 12 Predose, Week 26 Predose and Hours 3 and 6, Week 39 Predose, Week 52 Predose and Hours 3 and 6, Week 54 Predose |
|
|
|
| 15 |
| 440 |
| 0 |
| 440 |
| Coronary artery disease | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Chronic sinusitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | 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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| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 18.0 | 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 |
| Title | Measurements |
|---|---|
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| Week 4 (Hour 3) |
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| Week 4 (Hour 6) |
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| Week 12 (Predose) |
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| Week 26 (Predose) |
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| Week 26 (Hour 3) |
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| Week 26 (Hour 6) |
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| Week 39 (Predose) |
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| Week 52 (Predose) |
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| Week 52 (Hour 3) |
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| Week 52 (Hour 6) |
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| Week 54 (Predose) |
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