Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design Study to Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis.

Taro Pharmaceuticals USA0 sites1,053 target enrollmentMay 2012

ConditionsTinea Pedis

InterventionsNaftifine HCl Cream 1%Naftin® (Naftifine HCl) Cream 1%Placebo topical cream

DrugsPlacebo topical cream Naftifine HCl Cream 1%Naftin® (Naftifine HCl) Cream 1%

Overview

Phase: Phase 1
Intervention: Naftifine HCl Cream 1%
Conditions: Tinea Pedis
Sponsor: Taro Pharmaceuticals USA
Enrollment: 1053
Primary Endpoint: Therapeutic Cure
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the efficacy and safety of the test formulation of Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) as compared to the already marketed formulation Naftin® (Naftifine HCl) 1% Cream (Merz Pharmaceuticals) and placebo in patients with tinea pedis and to show the superiority of the active treatments over placebo when dosed once a day for 28 days.

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

July 2013

Last Updated

11 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 of age or older.
•Signed informed consent form, which meets all criteria of current FDA regulations.
•If female and of child-bearing potential, have a negative urine pregnancy test at baseline visit, and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study.
•A total score of at least 4 for the clinical signs and symptoms of tinea pedis for the target lesion. In addition, the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for scaling.
•A confirmed 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 tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic 10% potassium hydroxide wet mount examination.

Exclusion Criteria

•Females who are pregnant, lactating or likely to become pregnant during the study.
•Use of antipruritics, including antihistamines within 72 hours prior to baseline visit.
•Use of topical corticosteroids, antibiotics or antifungal therapies within 2 weeks prior to baseline visit.
•Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit.
•Use of oral terbinafine or itraconazole within 2 months prior to baseline visit.
•Use of immunosuppressive medication or radiation therapy within 3 months prior to baseline visit.
•Any known hypersensitivity to Naftifine HCl, any component of the formulation or other antifungal agents.
•Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
•Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place the patient at undue risk by participation or could jeopardize the integrity of the study evaluations.
•Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with the evaluation of tinea pedis.

Arms & Interventions

Naftifine HCl Cream 1%

Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.)

Intervention: Naftifine HCl Cream 1%

Naftin® (Naftifine HCl) Cream 1%

Naftin® (Naftifine HCl) Cream 1% (Merz Pharmaceuticals)

Intervention: Naftin® (Naftifine HCl) Cream 1%

Placebo topical cream

Placebo topical cream (Taro Pharmaceuticals Inc.)

Intervention: Placebo topical cream

Outcomes

Primary Outcomes

Therapeutic Cure

Time Frame: 42 Days

Patients with both mycological cure and clinical cure at the final follow-up visit two weeks fter the end of treatment (Day 42) will be considered therapeutic cures.