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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Pharmaceutical Solutions; Terbinafine

Criteria

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