Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Terbinafine · 5 trials · 3 indications
Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale: 0 = absent 1. = mild 2. = moderate 3. = severe In order to calculate the total symptoms score the rating for all symptoms are added up. Possible range 0 to 18
Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes. and no residual involvement of the target toenail. The complete cure was a composite binary variable defined as "Yes" if: * Mycological cure (negative KOH and negative culture for dermatophytes) and * No residual involvement of the target toenail "No" if otherwise
| Arm | Type | Description |
|---|---|---|
| Terbinafine | EXPERIMENTAL | Drug |
| Placebo | PLACEBO_COMPARATOR | Drug |
| 1 | EXPERIMENTAL | Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks |
| 2 | PLACEBO_COMPARATOR | Vehicle (placebo) for 48 weeks |
| 3 | EXPERIMENTAL | Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks |
| 4 | PLACEBO_COMPARATOR | Vehicle (placebo) for 24 weeks |
| Name | Type | Description |
|---|---|---|
| Terbinafine | DRUG | 1% single application |
| Terbinafine Placebo | DRUG | single application |
| Placebo | DRUG | Vehicle (placebo) once daily for 48 weeks |
| 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 ≥18 years of age with interdigital tinea pedis infection, with clinical diagnosis meeting required baseline total sign \& symptom score and positive microscopy Exclusion Criteria: * Allergy to the allylamine class of antimycotics or excipients in the formulation. * ...
Terbinafine is a small molecule antifungal drug developed by Novartis AG for the treatment of fungal infections, including Tinea Pedis (athlete's foot), Onychomycosis (toenail fungus), and Tinea Capitis (scalp ringworm). It is being studied in Phase 3 clinical trials for these indications.
Terbinafine is developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the drug's efficacy and safety in treating various fungal infections.
Terbinafine is in Phase 3 clinical development. It has completed four Phase 3 trials, including studies in Tinea Capitis, Onychomycosis, and Tinea Pedis. The drug is investigational and has not yet been approved by regulatory authorities for these indications.
Terbinafine has completed four Phase 3 trials. NCT00117754 compared it to griseofulvin in children with Tinea Capitis. NCT00443820 and NCT00443898 studied topical terbinafine in patients with toenail fungus. NCT01433107 evaluated a film forming solution in patients with Tinea Pedis.
Terbinafine is the generic name for the drug, which is also known by the brand name Lamisil. The clinical trials conducted by Novartis evaluate the efficacy and safety of terbinafine in treating fungal infections such as Tinea Pedis, Onychomycosis, and Tinea Capitis.