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

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

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.

Study Overview

• Status: Unknown
• Conditions: Tinea Pedis
• Intervention / Treatment: Drug: TERBINAFINE HYDROCHLORIDE (1%); Drug: BUTENAFINE HYDROCHLORIDE (1%); Drug: Vehicle Control

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Juliene Co, PhD; Phone Number: 8553 (632)8580001; Email: julieneco@gmail.com

Study Locations

• Philippines
  • Muntinlupa, Philippines
    • Recruiting
    • Clinical Trial Management and Testing Associates, Inc.
    • Contact: Gertrude Chan, M.D.; Phone Number: (632) 659-3238; Email: clintrialtest@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Control	Drug: Vehicle Control; Topical liquid solution
Experimental: Treatment # 1	Drug: TERBINAFINE HYDROCHLORIDE (1%); Topical liquid solution
Experimental: Treatment # 2	Drug: BUTENAFINE HYDROCHLORIDE (1%); Topical liquid solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: United Laboratories

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Anticipated): December 13, 2019
• Study Completion (Anticipated): January 3, 2020

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: June 24, 2019
• First Posted (Actual): June 26, 2019

Study Record Updates

• Last Update Posted (Actual): June 26, 2019
• Last Update Submitted That Met QC Criteria: June 24, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Foot Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Skin Manifestations; Dermatomycoses; Foot Dermatoses; Pruritus; Tinea; Tinea Pedis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antifungal Agents; Terbinafine; Butenafine
• Other Study ID Numbers: RD2018-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No