SINGLE-APPLICATION TERBINAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION VERSUS A SINGLE-APPLICATION BUTENAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION FOR THE TREATMENT OF TINEA PEDIS

Last updated: June 24, 2019
Sponsor: United Laboratories
Overall Status: Active - Recruiting

Phase

2

Condition

Athlete's Foot (Tinea Pedis)

Fungal Infections

Yeast Infections

Treatment

N/A

Clinical Study ID

NCT03999437
RD2018-02
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Tinea pedis or athlete's foot is the most common fungal infection worldwide, caused by infection of the feet with dermatophytes such as Trichophyton rubrum, Trichophyton interdigitale (formerly Trichophyton mentagrophytes), and Epidermophyton floccosum. Diagnosis of tinea pedia involves clinical symptoms as well as microscopic examination. Topical therapies are usually applied once or twice daily for as long as 4 weeks, posing a challenge to compliance. The current study aims to test a formulation of the single-dose 1% terbinafine hydrochloride, as well as a single-dose 1% butenafine hydrochloride, versus a vehicle control in adult Filipino patients with athlete's foot. This study will benefit the Filipino community by helping us determine which anti-fungal cream is most effective for athlete's foot.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or nonpregnant females aged 18-60 years old.

  • Clinical diagnosis of tinea pedis (total sign/symptom score >2), lesions between thetoes, with possible extension to the lateral surfaces and soles of the feet confirmedby a positive microscopy prior to dosing.

  • Willing to sign the informed consent.

Exclusion

Exclusion Criteria:

  • Females who are pregnant (confirmed by a pregnancy test), suspect themselves to bepregnant (even if pregnancy test is negative), breast-feeding, or planning apregnancy.

  • Signs of systemic or other superficial fungal disease (e.g.onychomycosis), clinicallyrelevant abnormal findings upon physical examination of the foot or previous treatmentwith a disallowed medication (such as corticosteroids).

  • Presence of non-healing wounds and/or bacterial infection on the feet.

  • Secondary bacterial infection due to tinea pedis

  • Presence of pigmentation, extensive scarring, or pigmented lesions in the treatmentareas, which could interfere with the rating of efficacy parameters.

  • History of hypersensitivity to any component of the test products.

  • Current imuunosuppression. Specifically, these include patients with co-morbiditiessuch as diabetes, HIV, chronic diseases requiring maintenance medications, acutefebrile/infectious illnesses (i.e. Dengue, pneumonia, etc)

  • Use within 3 months prior to baseline of: 1.) chemotherapy, or 2.) radiation therapy

Study Design

Total Participants: 42
Study Start date:
January 02, 2019
Estimated Completion Date:
January 03, 2020

Connect with a study center

  • Clinical Trial Management and Testing Associates, Inc.

    Muntinlupa,
    Philippines

    Active - Recruiting

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