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

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ClinicalTrials.gov Identifier: NCT03999437
Recruitment Status : Recruiting
First Posted : June 26, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
United Laboratories

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.

Condition or disease Intervention/treatment Phase
Tinea Pedis Drug: TERBINAFINE HYDROCHLORIDE (1%) Drug: BUTENAFINE HYDROCHLORIDE (1%) Drug: Vehicle Control Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : December 13, 2019
Estimated Study Completion Date : January 3, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment # 1 Drug: TERBINAFINE HYDROCHLORIDE (1%)
Topical liquid solution

Experimental: Treatment # 2 Drug: BUTENAFINE HYDROCHLORIDE (1%)
Topical liquid solution

Placebo Comparator: Placebo Control Drug: Vehicle Control
Topical liquid solution




Primary Outcome Measures :
  1. Proportion of participants with effective treatment at week 6 [ Time Frame: 6 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03999437


Contacts
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Contact: Juliene Co, PhD (632)8580001 ext 8553 julieneco@gmail.com

Locations
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Philippines
Clinical Trial Management and Testing Associates, Inc. Recruiting
Muntinlupa, Philippines
Contact: Gertrude Chan, M.D.    (632) 659-3238    clintrialtest@gmail.com   
Sponsors and Collaborators
United Laboratories

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Responsible Party: United Laboratories
ClinicalTrials.gov Identifier: NCT03999437     History of Changes
Other Study ID Numbers: RD2018-02
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms
Terbinafine
Butenafine
Pharmaceutical Solutions
Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action