A Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of a Generic Butenafine Hydrochloride Cream, 1% and Reference Listed Lotrimin Ultra® (Butenafine Hydrochloride Cream, 1%) and Compare Both Active Treatments to a Vehicle Control in the Treatment of Interdigital Tinea Pedis.

Taro Pharmaceuticals USA0 sites707 target enrollmentJanuary 2012

ConditionsTinea Pedis

InterventionsButenafine Hydrochloride Cream, 1%Lotrimin Ultra®Butenafine Vehicle

DrugsButenafine Hydrochloride Cream, 1%Lotrimin Ultra®Butenafine Vehicle

Overview

Phase: Phase 1
Intervention: Butenafine Hydrochloride Cream, 1%
Conditions: Tinea Pedis
Sponsor: Taro Pharmaceuticals USA
Enrollment: 707
Primary Endpoint: Therapeutic Cure
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The primary objective of this study is to determine the comparability of the safety and efficacy of a generic Butenafine Hydrochloride Cream, 1% (test product) and Lotrimin Ultra® (the reference listed drug) in subjects with interdigital tinea pedis. It will also be determined whether the efficacy of each of the two active treatments is superior to that of the vehicle cream (placebo).

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

December 2012

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Taro Pharmaceuticals USA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willing \& able to provide \& understand written informed consent
•Healthy male or non-pregnant, non-lactating female at least 18 years of age and older
•Clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or that is predominantly interdigital but may extend to other areas
•Tinea pedis provisionally confirmed at baseline by positive potassium hydroxide (KOH)wet mount preparation showing segmented fungal hyphae
•Has sum of the clinical signs and symptoms scores of the target lesion of at least 4, including a minimum score of 2 for erythema \& a minimum score of 2 for scaling or pruritus
•Currently in general good health with no clinically significant disease
•Willing and able to understand and comply with study requirements
•Women of childbearing potential must have a negative urine pregnancy test and be willing to use an acceptable form of birth control during study

Exclusion Criteria

•Females who are pregnant, breastfeeding, planning a pregnancy, or do not agree to use an acceptable form of birth control during the study
•Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface
•Presence of any other infection of the foot or other disease that might confound treatment evaluation
•History of dermatophyte infections unresponsive to antifungal drugs
•Known hypersensitivity to Butenafine Hydrochloride or any component of the study medications
•Use of antipruritics, topical systemic corticosteroid, antibiotic or antifungal therapy, oral terbinafine or itraconazole, or immunosuppressive medication or radiation therapy more recently than indicated washout period
•Current oral, vaginal, or mucocutaneous candidiasis
•Current bacterial skin infection, secondary cellulitis, lymphangitis, or pyoderma
•Presence of current conditions that require systemic antimicrobial or antifungal therapy
•Uncontrolled diabetes mellitus, peripheral vascular disease, chronic venous stasis, or other significant condition