Brief Summary

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Official Title: "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.

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Study Primary Completion Date: February 2012

Interventions Used in this Clinical Trial

• Drug: Terbinafine
  • 1% single application
• Drug: Terbinafine Placebo
  • single application

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Terbinafine
  • Drug
• Placebo Comparator: Placebo
  • Drug

Outcome Measures for this Clinical Trial

Primary Measures

• Effective treatment outcome (direct microscopy and culture negative and total signs and symptom score less or equal to 2)
  • Time Frame: week 6
    Safety Issue?: No

Secondary Measures

• Individual and total clinical signs and symptoms (S/S) scores
  • Time Frame: week 6
    Safety Issue?: No
• Number of Subjects with adverse event
  • Time Frame: 6 weeks
    Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Novartis
• Provider of Information About this Clinical Study
  • Sponsor