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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02132260

Enrollment

890

Registered

2014-05-07

Start date

2013-08-31

Completion date

2014-03-31

Last updated

2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinea Pedis

Keywords

Naftifine, Naftin®, Tinea pedis

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.

Interventions

DRUGNaftifine Hydrochloride Cream 2%

Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.) applied once-daily for two weeks

DRUGNaftin® (Naftifine Hydrochloride) Cream 2%

Naftin® (Naftifine Hydrochloride) Cream 2% (Merz Pharmaceuticals, LLC) applied once-daily for two weeks.

DRUGPlacebo Topical Cream

Placebo Topical Cream (Taro Pharmaceuticals Inc.) applied once-daily for two weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Therapeutic Cure	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026