Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AT-004 · 1 trial · 1 indication
Incidence of Treatment-Emergent Adverse Events in response to AT-004 administered topically in subjects with Acne vulgaris. Assessment of the amount of mild and severe adverse events related to the treatment.
Safety labs parameters not being outside of normal ranges and/or not clinically significant as assessed by the PI.
Incidence of inflammatory and non-inflammatory lesions at baseline and week 8.
| Arm | Type | Description |
|---|---|---|
| AT-004 treatment | EXPERIMENTAL | Participants randomized to receive AT-004 according to protocol |
| Placebo | PLACEBO_COMPARATOR | Participants randomized to receive matching placebo according to the protocol |
| Name | Type | Description |
|---|---|---|
| AT-004 | DRUG | Participants receiving AT-004 topical application |
| Placebo | DRUG | Participants receiving matching placebo topical application |
Inclusion Criteria: 1. The individual is between 18 years and 45 years old. 2. At Screening visit and Visit 1/Baseline has mild, moderate or severe facial acne (defined as an Investigator Global Assessment \[IGA\] score of 2 or more on the face) 3. At least \[=\>10 inflammatory lesions and =\>15 no...