Last updated on August 2009

Once a Day Topical Treatment for Athlete's Foot Fungus Inbetween the Toes in Males and Females


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Foot Fungus | Ringworm | Tinea Pedis | Athlete's Foot
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    Males and females 18 years of age and over.
    Women of child bearing age must have a negative urine pregnancy test at Day 0
    (baseline) and Day 42 (visit 6) or at the discontinuation visit and must agree to use
    an acceptable method of contraception during the study.
    Subjects must have clinical evidence of interdigital tinea pedis of one or both feet
    characterized by: moderate erythema and scaling and mild pruritis.
    The clinical diagnosis must be confirmed by a positive KOH preparation, where fungal
    elements are visible from a skin scraping of the interdigital area of the feet.
    Fungal cultures obtained at the baseline visit must be positive by day 14 for the
    ubject to remain in the study.
    All non-study medications not specifically excluded by this protocol may be
    continued.
    All chronic diseases must be stable for at least one month.
    Acute illnesses must be stabilized before enrollment.
    The subject must be able to understand what is required, read and sign the informed
    consent, comply with the requirements of this study and adhere to the visit schedule.

You may not be eligible for this study if the following are true:

  • Under 18 years of age.
    Pregnant or lactating females.
    Treatment of sertaconazole or an investigational drug within the last 30 days prior
    to study enrollment.
    No medications or emollients or foot powders or treatments other than those used in
    the study are to be applied to the treatment areas.
    The following medications may not be used during the study:
    Oral anti-fungals 3 months prior to enrollment
    Topical anti-fungals to the feet 14 days prior to enrollment
    Systemic antibiotic or corticosteroid 30 days prior to enrollment
    Topical corticosteroid 30 days prior to enrollment
    Use of radiation therapy and/or anti-neoplastic agents within1 year of
    enrollment
    Widespread dermatophytosis: moccasin tinea pedis, onychomycosis, oral, vaginal or
    chronic mucocutaneous candidiasis, bacterial skin infection.
    Subject who are known or suspected to be immunocompromised.
    Known sensitivity to any components of the test medication or hypersensitivity to
    imidazoles.
    Any disease or condition that may compromise the evaluation of the therapeutic
    response of tinea pedis to treatment.
    History of drug or alcohol dependency in the last 6 months.
    History of atopic or contact dermatitis on the feet.
    Unstable diabetes mellitus.
    Subjects who have participated in any previous clinical trial of sertaconazole.
    Subjects who cannot or will not sign the informed consent.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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