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

Sponsor
Taro Pharmaceuticals USA (Industry)
Overall Status
Completed
CT.gov ID
NCT02132260
Collaborator
(none)
890
Enrollment
3
Arms
7
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Naftifine Hydrochloride Cream 2%
  • Drug: Naftin® (Naftifine Hydrochloride) Cream 2%
  • Drug: Placebo Topical Cream
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
890 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

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

    Placebo Topical Cream

    Drug: Placebo Topical Cream
    Placebo Topical Cream (Taro Pharmaceuticals Inc.) applied once-daily for two weeks.
    Other Names:
  • vehicle

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Taro Pharmaceuticals USA

    Investigators

    • Study Chair: Catawba Research, http://catawbaresearch.com/contact/
    • Study Director: Natalie Yantovskiy, Taro Pharmaceuticals USA Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Taro Pharmaceuticals USA
    ClinicalTrials.gov Identifier:
    NCT02132260
    Other Study ID Numbers:
    • NFTC 1301
    First Posted:
    May 7, 2014
    Last Update Posted:
    May 9, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Taro Pharmaceuticals USA
    Naftifine
    Naftin®
    Tinea pedis
    Additional relevant MeSH terms:
    Tinea
    Tinea Pedis
    Naftifine

    Study Results

    No Results Posted as of May 9, 2017