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

NCT03999437 | Unknown Phase 2

• 1 other identifier: RD2018-02
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Treatment # 1

EXPERIMENTAL

Drug: TERBINAFINE HYDROCHLORIDE (1%)

Treatment # 2

EXPERIMENTAL

Drug: BUTENAFINE HYDROCHLORIDE (1%)

Placebo Control

PLACEBO COMPARATOR

Drug: Vehicle Control

Interventions

TERBINAFINE HYDROCHLORIDE (1%) DRUG

Topical liquid solution

Treatment # 1

BUTENAFINE HYDROCHLORIDE (1%) DRUG

Topical liquid solution

Treatment # 2

Vehicle Control DRUG

Topical liquid solution

Placebo Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• United Laboratories: lead

Study Sites (1)

Clinical Trial Management and Testing Associates, Inc.

City of Muntinlupa, Philippines

RECRUITING

MeSH Terms

Conditions

Tinea Pedis

Interventions

Terbinafine; butenafine

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Central Study Contacts

Juliene Co, PhD

CONTACT

(632)8580001; julieneco@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: January 2, 2019
• Primary Completion: December 13, 2019
• Study Completion: January 3, 2020
• Last Updated: June 26, 2019

Record last verified: 2019-06

Locations

PH (1)