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

A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study of the Efficacy and Safety of Terbinafine Film Forming Solution, 1% (as Hydrochloride), in Patients With Tinea Pedis

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.

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