Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis

Novartis

Status and phase: Completed; Phase 3

Conditions: Tinea Pedis

Treatments: Drug: Terbinafine Placebo; Drug: Terbinafine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01433107

727-D-301

Details and patient eligibility

About

This study will compare the efficacy and safety of a single dose of terbinafine film forming solution 1% with a single dose of placebo film forming solution in the treatment of tinea pedis.

Enrollment: 290 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.
• Chronic, hyperkeratotic plantar (moccasin) tinea pedis
• Other fungal disease or intertrigo
• Other abnormal findings on the affected foot
• Systemic antifungal or antimicrobial treatment within the last 3 months
• Topical treatment for skin lesions on feet within the last 3 months
• Diabetes mellitus and peripheral artery occlusive disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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290 participants in 2 patient groups, including a placebo group

Terbinafine

Experimental group

Description:

Drug

Treatment:

Drug: Terbinafine

Placebo

Placebo Comparator group

Description:

Drug

Treatment:

Drug: Terbinafine Placebo