Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Within-Subject Active vs Placebo Topical Applications
Within-Subject Active vs Placebo Applications · 1 trial · 1 indication
Comparison of investigator-reported (Application Site Skin Examination \[0 to 3 points\]) and participant-reported (Local Tolerability Assessment Scale scores \[0 to 3 points\]) application site TEAEs in crisaborole treated versus vehicle-treated at all 7 prespecified sensitive skin sites.
| Arm | Type | Description |
|---|---|---|
| Group A (Crisaborole RIGHT SIDE / Vehicle LEFT SIDE) | OTHER | Crisaborole ointment 2% applied to sensitive skin locations on right side of body. Crisaborole placebo vehicle ointment applied to sensitive skin locations on left side of body |
| Group B (Crisaborole LEFT SIDE / Vehicle RIGHT SIDE) | OTHER | Crisaborole placebo vehicle ointment applied to 7 sensitive skin sites on right side of body. Crisaborole ointment 2% applied to 7 sensitive skin locations on left side of body |
| Name | Type | Description |
|---|---|---|
| Within-Subject Active vs Placebo Topical Applications | DRUG | Crisaborole 2% ointment (right side) and Placebo vehicle ointment (left side) |
| Within-Subject Active vs. Placebo Topical Applications | DRUG | Crisaborole 2% ointment (left side) and Placebo vehicle ointment (right side) |
Inclusion Criteria: * Male and female adult participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests. Exclusion Criteria: * Prior self-reported history of any chronic relapsing inflammatory skin disease, includi...