Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02218034 | Safety, Tolerability and Pharmacokinetics of AGN-190168 in Subjects With Acne Vulgaris | PHASE1 | COMPLETED | 78 | — | — | Aug 1, 2014 | Mar 1, 2015 | Apr 30, 2015 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| 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. |
| 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. |
Inclusion Criteria: * Diagnosis of acne vulgaris on the face * No tobacco use for the past 30 days, and willing to refrain from nicotine use during the study * Willing to avoid excessive or prolonged exposure of the treated skin to ultraviolet light (eg, sunlight, tanning beds) and extremes in weat...