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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06233591 | Evaluating LP-10 in Subjects With OLP | PHASE2 | ACTIVE NOT_RECRUITING | 24 | — | — | Jul 1, 2024 | Jun 1, 2025 | May 15, 2025 | 7 | United States |
Incidence and severity of treatment-emergent adverse events, changes in standard laboratory studies, whole-blood tacrolimus levels
| Arm | Type | Description |
|---|---|---|
| LP-10 0.25mg | EXPERIMENTAL | 0.25mg LP-10 / 10 mL twice daily oral rinse |
| LP-10 0.5 mg | EXPERIMENTAL | 0.5mg LP-10 / 10 mL twice daily oral rinse |
| LP-10 1.0 mg | EXPERIMENTAL | 1.0mg LP-10 / 10 mL twice daily oral rinse |
| Name | Type | Description |
|---|---|---|
| LP-10 (Liposomal Tacrolimus) | DRUG | Liposomal oral rinse formulation of Tacrolimus |
Inclusion Criteria: * Provide written informed consent * Male or female ≥ 18 years of age * Oral biopsy performed within the last 10 years before the Screening Visit demonstrating OLP and/or oral lichenoid mucositis in the absence of cancer or dysplasia * Moderate OLP based on an OLP Investigator G...