CClinicalTrials.gg
Status unknownNCT03999437Updated Jun 26, 2019

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

A Phase 2 interventional study of TERBINAFINE HYDROCHLORIDE (1%) and BUTENAFINE HYDROCHLORIDE (1%) in Tinea Pedis, sponsored by United Laboratories. Status unknown at 1 site in Philippines. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-26.

Sponsored by United Laboratories · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tinea Pedis

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03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Treatment # 1

    Drug: TERBINAFINE HYDROCHLORIDE (1%)

  • Experimental
    Treatment # 2

    Drug: BUTENAFINE HYDROCHLORIDE (1%)

  • Placebo comparator
    Placebo Control

    Drug: Vehicle Control

Interventions

  • DrugTERBINAFINE HYDROCHLORIDE (1%)

    Topical liquid solution

  • DrugBUTENAFINE HYDROCHLORIDE (1%)

    Topical liquid solution

  • DrugVehicle Control

    Topical liquid solution

05

What researchers measure

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.

    Time frame: 6 weeks

06

Study locations

1 of 1 sites recruiting
  • Clinical Trial Management and Testing Associates, Inc.
    Muntinlupa, Philippines
    Recruiting
07

Registry details

Key details

Study ID
NCT03999437
Lead sponsor
United Laboratories
Responsible party
Sponsor
First posted
Jun 26, 2019
Start date
Jan 2, 2019
Primary completion
Dec 13, 2019 (estimated)
Completion
Jan 3, 2020 (estimated)
Last update
Jun 26, 2019

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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