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

NCT ID: NCT03999437

Last Updated: 2019-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-02
• Study Completion Date: 2020-01-03

Brief 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.

Conditions

Tinea Pedis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment # 1

Group Type: EXPERIMENTAL

TERBINAFINE HYDROCHLORIDE (1%)

Intervention Type: DRUG

Topical liquid solution

Treatment # 2

Group Type: EXPERIMENTAL

BUTENAFINE HYDROCHLORIDE (1%)

Intervention Type: DRUG

Topical liquid solution

Placebo Control

Group Type: PLACEBO_COMPARATOR

Vehicle Control

Intervention Type: DRUG

Topical liquid solution

Interventions

TERBINAFINE HYDROCHLORIDE (1%)

Topical liquid solution

Intervention Type: DRUG

BUTENAFINE HYDROCHLORIDE (1%)

Topical liquid solution

Intervention Type: DRUG

Vehicle Control

Topical liquid solution

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Trial Management and Testing Associates, Inc.

City of Muntinlupa, , Philippines

Site Status: RECRUITING

Countries

Philippines

Central Contacts

Juliene Co, PhD

Role: CONTACT

julieneco@gmail.com

(632)8580001 ext. 8553

Facility Contacts

Gertrude Chan, M.D.

Role: primary

clintrialtest@gmail.com

(632) 659-3238

Other Identifiers

RD2018-02

Identifier Type: -

Identifier Source: org_study_id