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

Sponsor
Taro Pharmaceuticals USA (Industry)
Overall Status
Completed
CT.gov ID
NCT02335255
Collaborator
(none)
1,519
Enrollment
3
Arms
46.6
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

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

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 Design

Study Type:
Interventional
Actual Enrollment :
1519 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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.
Actual Study Start Date :
Jun 27, 2014
Actual Primary Completion Date :
May 15, 2018
Actual Study Completion Date :
May 15, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    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 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Taro Pharmaceuticals USA

    Investigators

    • Study Chair: Catawba Research, http://catawbaresearch.com/contact/

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Taro Pharmaceuticals USA
    ClinicalTrials.gov Identifier:
    NCT02335255
    Other Study ID Numbers:
    • NFTC 1409-1722
    First Posted:
    Jan 9, 2015
    Last Update Posted:
    Sep 6, 2018
    Last Verified:
    Sep 1, 2018
    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
    Additional relevant MeSH terms:
    Tinea
    Tinea Pedis
    Naftifine

    Study Results

    No Results Posted as of Sep 6, 2018