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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06050122 | Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome | PHASE3 | ACTIVE NOT_RECRUITING | 140 | — | — | Mar 17, 2024 | Aug 1, 2026 | Oct 14, 2025 | 40 | United States, France +5 |
New BCCs at Month 12 after twice-daily treatment with either Patidegib Gel 2% or Vehicle Gel for 12 months, as assessed by the CPRB
| Arm | Type | Description |
|---|---|---|
| Patidegib Gel 2% | EXPERIMENTAL | Patidegib Gel 2% (w/w), applied topically to the face twice daily for 12 months |
| Vehicle Gel | PLACEBO_COMPARATOR | Vehicle Gel, applied topically to the face twice daily for 12 months |
| Name | Type | Description |
|---|---|---|
| Patidegib Topical Gel | DRUG | Patidegib Gel 2% is a smooth, clear, colorless-to-yellow, viscous, hydro-alcoholic gel for topical administration. |
| Patidegib Topical Gel with no active patidegib | DRUG | Vehicle Gel consists of the excipients of Patidegib Gel with no active patidegib. It is a smooth viscous gel for topical administration. |
Key Inclusion Criteria: 1. The subject must be at least 18 years old at the Screening Visit. 2. The subject must be confirmed to have a PTCH1 mutation. 3. The subject must have at least 10 BCCs on the face at Randomization (Baseline/Day 1). 4. The subject must be willing to abstain from application...