Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis

A Multi-Center, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® (Naftifine Hydrochloride) Gel 2% in Patients With Tinea Pedis.

To compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2%

Study Overview

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

Detailed Description

The purpose of this study is to compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2% in a six week study (four weeks after the end of two week treatment) in patients with tinea pedis.

• Study Type: Interventional
• Enrollment (Actual): 1519
• 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 of age or older.
• 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.
• Clinical diagnosis of interdigital 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, confirmed by the observation of segmented fungal hyphae during a microscopic potassium hydroxide wet mount preparation.

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 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 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 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 investigator's evaluation of tinea pedis.
• Patients with a past history of dermatophyte infections with a lack of response to antifungal therapy.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Naftifine Hydrochloride Gel 2%; Naftifine Hydrochloride Gel 2% (Taro Pharmaceuticals Inc.)	Drug: Naftifine Hydrochloride Gel 2%; Naftifine Hydrochloride Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.; Other Names: Naftifine
Active Comparator: Naftin® Gel 2%; Naftin® (Naftifine Hydrochloride) Gel 2% (Merz Pharmaceuticals, LLC)	Drug: Naftin® Gel 2%; Naftin® Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.; Other Names: Naftifine
Placebo Comparator: Placebo Topical Gel; Placebo Topical Gel (Taro Pharmaceuticals Inc.)	Drug: Placebo Topical Gel; Placebo Topical Gel applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.; Other Names: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic cure after end of treatment	The proportion of subjects with therapeutic cure, defined as both mycological cure and clinical cure, at the test-of-cure visit conducted four weeks after the end of treatment (study day 38-46).	Study day 38-46

Collaborators and Investigators

• Sponsor: Taro Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2014
• Primary Completion (Actual): May 15, 2018
• Study Completion (Actual): May 15, 2018

Study Registration Dates

• First Submitted: January 7, 2015
• First Submitted That Met QC Criteria: January 8, 2015
• First Posted (Estimate): January 9, 2015

Study Record Updates

• Last Update Posted (Actual): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 4, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• 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 1409-1722

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