A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate the Safety and Efficacy of a Naftifine Hydrochloride Cream 2%and the Naftin® Cream 2% in Patients With Tinea Pedis

Taro Pharmaceuticals USA0 sites890 target enrollmentAugust 2013

ConditionsTinea Pedis

InterventionsNaftifine Hydrochloride Cream 2%Naftin® (Naftifine Hydrochloride) Cream 2%Placebo Topical Cream

DrugsNaftifine Hydrochloride Cream 2%Naftin® (Naftifine Hydrochloride) Cream 2%Placebo Topical Cream

Overview

Phase: Phase 1
Intervention: Naftifine Hydrochloride Cream 2%
Conditions: Tinea Pedis
Sponsor: Taro Pharmaceuticals USA
Enrollment: 890
Primary Endpoint: Therapeutic Cure
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The objective of this study is to compare the efficacy and safety of the test formulation of Naftifine Hydrochloride Cream 2% to Naftin® (Naftifine Hydrochloride) 2% Cream in a 6 week study in patients with tinea pedis.

Registry

clinicaltrials.gov

Start Date

August 2013

End Date

March 2014

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

•Male or non-pregnant, non-lactating females 18 years or older
•Clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot
•The presence of interdigital tinea pedis infection
•The sum of the clinical signs and symptoms scores of the target lesion is at least 4, including a minimum score of at least 2 for erythema and a minimum score of 2 for either scaling or pruritus

Exclusion Criteria

•Females who are pregnant, lactating or planning to become pregnant during the study period
•Use of antipruritics, including antihistamines within 72 hours prior to baseline visit
•Use of topical corticosteroids, antibiotics or antifungal therapies within two weeks prior to baseline visit
•Use of systemic corticosteroids, antibiotics or antifungal therapies within one month prior to baseline visit
•Use of oral terbinafine or itraconazole within two months prior to baseline visit
•Use of immunosuppressive medication or radiation therapy within three months prior to baseline visit
•Any known hypersensitivity to Naftifine Hydrochloride, or any component of the formulation
•Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface
•History of significant or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place undue risk by participation or could jeopardize the integrity of study evaluations
•Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with tinea pedis evaluation

Arms & Interventions

Naftifine Hydrochloride Cream 2%

Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.)

Intervention: Naftifine Hydrochloride Cream 2%

Naftin® Cream 2%

Naftin® (Naftifine Hydrochloride) Cream 2%

Intervention: Naftin® (Naftifine Hydrochloride) Cream 2%

Placebo Topical Cream

Intervention: Placebo Topical Cream

Outcomes

Primary Outcomes

Therapeutic Cure

Time Frame: 6 weeks

The proportion of subjects with therapeutic cure (both mycological cure and clinical cure) at the test-of-cure visit conducted four weeks after the end of treatment.