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

Last updated: December 3, 2013
Sponsor: Novartis
Overall Status: Completed

Phase

3

Condition

Fungal Infections

Athlete's Foot (Tinea Pedis)

Yeast Infections

Treatment

N/A

Clinical Study ID

NCT01433107
727-D-301
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients ≥18 years of age with interdigital tinea pedis infection, with clinicaldiagnosis meeting required baseline total sign & symptom score and positive microscopy

Exclusion

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

Study Design

Total Participants: 290
Study Start date:
August 01, 2011
Estimated Completion Date:
February 29, 2012

Connect with a study center

  • Beijing University Hospital N°3

    Beijing, 100083
    China

    Site Not Available

  • Peking University First Hospital

    Beijing, 100034
    China

    Site Not Available

  • The Second Affiliated Hospital of Sun Yat-sen University Guangzhou

    Guangdong, 510120
    China

    Site Not Available

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, 510630
    China

    Site Not Available

  • Chinese Academy of Medical Sciences

    Jiangsu, 21004
    China

    Site Not Available

  • Huashan Hospital, Fudan University

    Shanghai, 200040
    China

    Site Not Available

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