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

Phase 1

Completed

• Conditions: Tinea Pedis
• Interventions: Drug: Naftin® Gel 2%; Drug: Placebo Topical Gel; Drug: Naftifine Hydrochloride Gel 2%

• Registration Number: NCT02335255
• Lead Sponsor: Taro Pharmaceuticals USA

Brief Summary

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

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 Timeline

• Study Start: 2014-06-27
• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-08
• Study First Posted: 2015-01-09
• Primary Completion: 2018-05-15
• Study Completion: 2018-05-15
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1519

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naftin® Gel 2%	Naftin® Gel 2%	Naftin® (Naftifine Hydrochloride) Gel 2% (Merz Pharmaceuticals, LLC)
Placebo Topical Gel	Placebo Topical Gel	Placebo Topical Gel (Taro Pharmaceuticals Inc.)
Naftifine Hydrochloride Gel 2%	Naftifine Hydrochloride Gel 2%	Naftifine Hydrochloride Gel 2% (Taro Pharmaceuticals Inc.)

Primary Outcome Measures

Name	Time	Method
Therapeutic cure after end of treatment	Study day 38-46	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).