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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04188574 | A Trial Involving Treatment of BB2603 in Subjects With Distal Subungual Onychomycosis of the Toenail | PHASE2 | COMPLETED | 111 | — | — | Mar 22, 2021 | Jun 28, 2023 | Aug 1, 2023 | 20 | Czechia, Germany +1 |
Early Response is defined as clinimetrically assessed clear nail growth (yes/no) and/or negative dermatophyte culture (yes/no).
| Arm | Type | Description |
|---|---|---|
| BB2603-10 | EXPERIMENTAL | Treatment with topical spray twice-daily (BID) BB2603-10: 0.1% terbinafine |
| BB2603-3 | EXPERIMENTAL | Treatment with topical spray twice-daily (BID) BB2603-3: 0.03% terbinafine |
| BB2603-1 | EXPERIMENTAL | Treatment with topical spray twice-daily (BID)BB2603-1: 0.01% terbinafine |
| Vehicle Control | OTHER | 0.3% polyhexanide/ 20% ethanol/ water formulation. |
| Name | Type | Description |
|---|---|---|
| BB2603-1 | DRUG | Treatment with topical spray twice-daily (BID) BB2603-1: 0.01% terbinafine |
| BB2603-3 | DRUG | Treatment with topical spray twice-daily (BID) BB2603-3: 0.03% terbinafine |
| BB2603-10 | DRUG | Treatment with topical spray twice-daily (BID) BB2603-10: 0.1% terbinafine |
| Vehicle | OTHER | Treatment with topical spray twice-daily (BID): 0.3% polyhexanide/ 20% ethanol/ water formulation. |
Inclusion Criteria: 1. Male or female ≥18 (and ≤99) at the time of Informed Consent. 2. Clinically and mycologically (KOH and culture positive for dermatophytes \[microbial infection with fungus belonging to the genus Trichophyton, Microsporum, Epidermophyton\]) confirmed diagnoses of DSO of the ta...