Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea Pedis

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

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.

Study Overview

• Status: Completed
• Conditions: Tinea Pedis
• Intervention / Treatment: Drug: Naftifine Hydrochloride Cream 2%; Drug: Naftin® (Naftifine Hydrochloride) Cream 2%; Drug: Placebo Topical Cream

• Study Type: Interventional
• Enrollment (Actual): 890
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• Past history of dermatophyte infections with a lack of response ot antifungal therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Naftifine Hydrochloride Cream 2%; Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.)	Drug: Naftifine Hydrochloride Cream 2%; Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.) applied once-daily for two weeks; Other Names: Naftifine
Active Comparator: Naftin® Cream 2%; Naftin® (Naftifine Hydrochloride) Cream 2%	Drug: Naftin® (Naftifine Hydrochloride) Cream 2%; Naftin® (Naftifine Hydrochloride) Cream 2% (Merz Pharmaceuticals, LLC) applied once-daily for two weeks.; Other Names: Naftifine
Placebo Comparator: Placebo Topical Cream	Drug: Placebo Topical Cream; Placebo Topical Cream (Taro Pharmaceuticals Inc.) applied once-daily for two weeks.; Other Names: vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic Cure	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.	6 weeks

Collaborators and Investigators

• Sponsor: Taro Pharmaceuticals USA
• Investigators: Study Director: Natalie Yantovskiy, Taro Pharmaceuticals USA Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: May 5, 2014
• First Submitted That Met QC Criteria: May 5, 2014
• First Posted (Estimate): May 7, 2014

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 4, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Naftifine; Naftin®; Tinea pedis
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Foot Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Skin Manifestations; Dermatomycoses; Foot Dermatoses; Pruritus; Tinea; Tinea Pedis; Anti-Infective Agents; Antifungal Agents; Naftifine
• Other Study ID Numbers: NFTC 1301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No