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Antifungal

Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis

Phase 1
Waitlist Available
Research Sponsored by Taro Pharmaceuticals USA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days
Awards & highlights
All Individual Drugs Already Approved

Summary

To demonstrate comparable safety and efficacy of Taro Pharmaceuticals Inc. butenafine hydrochloride cream 1% (test product) and Lotrimin Ultra® cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).

Eligible Conditions
  • Athlete's Foot

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Therapeutic Cure - Superiority Analysis
Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra
Secondary study objectives
Clinical Cure
Mycologic Cure
Therapeutic Cure

Side effects data

From 2008 Phase 1 trial • 548 Patients • NCT00835510
5%
Headache
2%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Butenafine Cream 1% (Taro)
Lotrimin Ultra (Butenafine) 1%
Vehicle

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Butenafine cream 1% (Taro)Experimental Treatment1 Intervention
Butenafine cream manufactured by Taro applied for 7 days
Group II: Lotrimin Ultra (butenafine) 1%Active Control1 Intervention
Lotrimin Ultra (butenafine) applied for 7 days
Group III: VehiclePlacebo Group1 Intervention
Butenafine vehicle applied for 7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Butenafine
FDA approved

Find a Location

Who is running the clinical trial?

Taro Pharmaceuticals USALead Sponsor
72 Previous Clinical Trials
35,168 Total Patients Enrolled
~31 spots leftby Dec 2025
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