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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00459537 | Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride Versus 5% Amorolfine Nail Lacquer in Patients With Mild to Moderate Toenail Onychomycosis | PHASE3 | COMPLETED | 1,029 | — | — | Mar 1, 2007 | Jan 1, 2009 | May 6, 2011 | 10 | Finland, France +8 |
Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
| Arm | Type | Description |
|---|---|---|
| Terbinafine | EXPERIMENTAL | 10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry. |
| Amorolfine | ACTIVE_COMPARATOR | 5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails. |
| Name | Type | Description |
|---|---|---|
| terbinafine hydrogen chloride | DRUG | 10 % terbinafine hydrogen chloride (HCL) |
| amorolfine nail lacquer | DRUG | 5 % amorolfine nail lacquer |
Inclusion Criteria: * Male and females 12 - 75 years of age * Fungal toenail infection of one or both of the large (great) toenails * The nail infection must be due to a dermatophyte, (mixed infections \[dermatophyte and non-dermatophyte\] are not allowed) * The target toenail area must have at lea...