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

United Laboratories

Status and phase: Unknown; Phase 2

Conditions: Tinea Pedis

Treatments: Drug: Vehicle Control; Drug: TERBINAFINE HYDROCHLORIDE (1%); Drug: BUTENAFINE HYDROCHLORIDE (1%)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03999437

RD2018-02

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or nonpregnant females aged 18-60 years old.
• Clinical diagnosis of tinea pedis (total sign/symptom score >2), lesions between the toes, with possible extension to the lateral surfaces and soles of the feet confirmed by a positive microscopy prior to dosing.
• Willing to sign the informed consent.

Exclusion criteria

• Females who are pregnant (confirmed by a pregnancy test), suspect themselves to be pregnant (even if pregnancy test is negative), breast-feeding, or planning a pregnancy.
• Signs of systemic or other superficial fungal disease (e.g.onychomycosis), clinically relevant abnormal findings upon physical examination of the foot or previous treatment with 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 treatment areas, 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-morbidities such as diabetes, HIV, chronic diseases requiring maintenance medications, acute febrile/infectious illnesses (i.e. Dengue, pneumonia, etc)
• Use within 3 months prior to baseline of: 1.) chemotherapy, or 2.) radiation therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 3 patient groups, including a placebo group

Treatment # 1

Experimental group

Treatment:

Drug: TERBINAFINE HYDROCHLORIDE (1%)

Treatment # 2

Experimental group

Treatment:

Drug: BUTENAFINE HYDROCHLORIDE (1%)

Placebo Control

Placebo Comparator group

Treatment:

Drug: Vehicle Control