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This is a safety, tolerability and pharmacokinetics study of AGN-190168 in subjects with acne vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN-190168 Formulation 1 | Experimental | AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days. |
|
| AGN-190168 Formulation 2 | Experimental | AGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days. |
|
| TAZORAC® Gel 0.1% | Active Comparator | TAZORAC® Gel 0.1% (tazarotene gel 0.1%) applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days. |
|
| TAZORAC® Cream 0.1% | Active Comparator | TAZORAC® Cream 0.1% (tazarotene cream 0.1%) applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-190168 Formulation 1 | Drug | AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Level (Cmax) of AGN-190168 | Day 29 | |
| Maximum Plasma Level (Cmax) of AGN-190168 Metabolite | Day 29 | |
| Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale | Day 29 | |
| Local Dermal Tolerability as Assessed by the Investigator Using a 4-Point Scale | Day 29 |
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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 |
|---|---|---|---|---|---|---|
| College Station | Texas | United States |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| AGN-190168 Formulation 2 | Drug | AGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days. |
|
| tazarotene gel 0.1% | Drug | Tazarotene gel 0.1% applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days. |
|
|
| tazarotene cream 0.1% | Drug | Tazarotene cream 0.1% cream applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days. |
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