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

Tinea Pedis Clinical Trial

Official title:

EFFICACY AND SAFETY OF A SINGLE-APPLICATION TREATMENT USING TERBINAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION VERSUS A SINGLE-APPLICATION TREATMENT USING BUTENAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION FOR THE TREATMENT OF TINEA PEDIS: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03999437
• Other study ID #: RD2018-02
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2, 2019
• Est. completion date: January 3, 2020

Study information

• Verified date: June 2019
• Source: United Laboratories
• Contact: Juliene Co, PhD
• Phone: (632)8580001
• Email: julieneco[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: January 3, 2020
• Est. primary completion date: December 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Tinea
• Tinea Pedis

Intervention

Drug:
• TERBINAFINE HYDROCHLORIDE (1%)
Topical liquid solution
• BUTENAFINE HYDROCHLORIDE (1%)
Topical liquid solution
• Vehicle Control
Topical liquid solution

Locations

Country	Name	City	State
Philippines	Clinical Trial Management and Testing Associates, Inc.	Muntinlupa

Sponsors (1)

Lead Sponsor	Collaborator
United Laboratories

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with effective treatment at week 6	Defined as negative microscopy and improvement in signs and symptoms: mild or no erythema, desquamation or pruritis (<=1), no vesiculation, and a total sign/symptom score of <=2.	6 weeks