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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00781664 | Cumulative Irritation Test | PHASE1 | COMPLETED | 44 | — | — | Oct 1, 2008 | Nov 1, 2008 | Apr 16, 2019 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | AN2718 Cream SF Vehicle |
| B | EXPERIMENTAL | AN2718 Cream SF, 0.3% |
| C | EXPERIMENTAL | AN2718 Cream SF, 1% |
| D | EXPERIMENTAL | AN2718 Gel Vehicle |
| E | EXPERIMENTAL | AN2718 Gel, 1.5% |
| F | EXPERIMENTAL | AN2718 Gel, 2.5% |
| G | EXPERIMENTAL | AN2718 Gel, 5% |
| H | EXPERIMENTAL | AN2718 Gel, 7.5% |
| I | ACTIVE_COMPARATOR | Sodium Lauryl Sulfate, 0.5% |
| Name | Type | Description |
|---|---|---|
| AN2718 | OTHER | AN2718 Cream SF Vehicle, Daily for up to 21 days |
| Sodium Lauryl Sulfate | OTHER | Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days |
Inclusion Criteria: Subjects must meet all of the following criteria for inclusion in the study. 1. Healthy volunteers of either sex, at least 18 years of age or older. 2. Females must be of non-childbearing potential (i.e., post-menopausal or surgically sterile \[bilateral oophorectomy and/or tot...