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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00117754 | Terbinafine Compared to Griseofulvin in Children With Tinea Capitis | PHASE3 | COMPLETED | 720 | — | — | Jul 1, 2004 | Apr 1, 2006 | Feb 21, 2007 | 1 | United States |
| NCT00117767 | Terbinafine Compared to Griseofulvin in Children With Tinea Capitis | PHASE3 | COMPLETED | 720 | — | — | Jun 1, 2004 | - | May 31, 2017 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Terbinafine |
| 2 | ACTIVE_COMPARATOR | Griseofulvin |
| Name | Type | Description |
|---|---|---|
| Terbinafine hydrochloride | DRUG | - |
| Terbinafine hydrochloride (HCl) | DRUG | Terbinafine hydrochloride (HCl) pediatric formulation (minitablets)o.d. administration |
| Griseofulvin | DRUG | Griseofulvin pediatric suspension o.d. administration |
Inclusion Criteria: * Patients with clinical diagnosis of tinea capitis confirmed by positive KOH determined by the central mycology laboratory. * Male or female patients who are at least 4 years old and no more than 12 years old. Exclusion Criteria: * Patients having a medical condition that alt...