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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04104685 | A Study to Compare FCD105 Foam to Minocycline 3% Foam, Adapalene 0.3% Foam and Vehicle Foam. | PHASE2 | COMPLETED | 446 | — | — | Sep 18, 2019 | Mar 3, 2020 | Feb 5, 2021 | 35 | United States |
Statistical superiority of FCD105 vs. vehicle in the absolute change from Baseline in inflammatory lesion counts at Visit 4 (Week12/End of Treatment)
Statistical superiority of FCD105 vs. vehicle in the absolute change from Baseline in non-inflammatory lesion counts at Visit 4 (Week12/End of Treatment)
Statistical superiority of FCD105 vs. vehicle in in IGA Treatment Success at Visit 4 (Week 12/End of Treatment), where success is defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from Baseline.
| Arm | Type | Description |
|---|---|---|
| FCD105 Foam | EXPERIMENTAL | FCD105 Foam |
| 3% Minocycline Foam | ACTIVE_COMPARATOR | 3% Minocycline Foam |
| 0.3% Adapalene Foam | ACTIVE_COMPARATOR | 0.3% Adapalene Foam |
| Vehicle Foam | PLACEBO_COMPARATOR | Vehicle Foam |
| Name | Type | Description |
|---|---|---|
| FCD105 | COMBINATION_PRODUCT | Experimental combination |
| 3% Minocycline Foam | DRUG | Active Comparator |
| 0.3% Adapalene Foam | DRUG | Active Comparator |
| Vehicle Foam | OTHER | Placebo |
Inclusion Criteria: 1. Has facial acne vulgaris with all of the following: 1. 20 to 50 inflammatory lesions (papules and/or pustules) on the face. 2. 25 to 100 non-inflammatory lesions (open and closed comedones) on the face. 3. IGA score of moderate (3) to severe (4). 2. No more than two...