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Also known as Terbinafine hydrochloride, Terbinafine hydrochloride (HCl), Lamisil
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 an antifungal medicine used to treat fungal infections of the skin and nails. Its studied indications include onychomycosis, a fungal infection of the toenails, tinea capitis, a scalp infection in children, and tinea pedis, commonly known as athlete's foot. It is a small molecule therapeutic in the infectious disease area.
Terbinafine is developed by Novartis AG, which trades under the ticker NVS. The company has sponsored Phase 3 clinical trials of the drug in onychomycosis, tinea capitis, and tinea pedis.
Terbinafine has been studied in Phase 3 clinical development. The trials listed for the drug are completed, and no active trials are currently recorded. The program includes randomized, double-blind, placebo-controlled studies across its studied fungal infection indications.
Terbinafine has been evaluated in completed Phase 3 trials including NCT01433107 in tinea pedis in China, NCT00443898 and NCT00443820 in onychomycosis of the big toenail, and NCT00117767 comparing terbinafine to griseofulvin in children with tinea capitis in the United States. Total enrollment across these studies was 1,440 participants.
Yes. Terbinafine is also known as terbinafine hydrochloride and terbinafine hydrochloride (HCl). These names refer to the same antifungal small molecule developed by Novartis AG for fungal infections including onychomycosis, tinea capitis, and tinea pedis.