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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02132260
Recruitment Status : Completed
First Posted : May 7, 2014
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Study Description
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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
Tinea Pedis Drug: Naftifine Hydrochloride Cream 2% Drug: Naftin® (Naftifine Hydrochloride) Cream 2% Drug: Placebo Topical Cream Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : August 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: 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 Name: vehicle


Outcome Measures
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Primary Outcome Measures :
  1. Therapeutic Cure [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132260


Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
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Study Chair: Catawba Research http://catawbaresearch.com/contact/
Study Director: Natalie Yantovskiy Taro Pharmaceuticals USA Inc.
More Information
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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT02132260    
Other Study ID Numbers: NFTC 1301
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Tinea
Tinea Pedis
Dermatomycoses
Mycoses
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Skin Diseases
 Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Naftifine
Antifungal Agents
Anti-Infective Agents