Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea Pedis
NCT ID: NCT02132260
Last Updated: 2017-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
890 participants
INTERVENTIONAL
2013-08-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Naftifine Hydrochloride Cream 2%
Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.)
Naftifine Hydrochloride Cream 2%
Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.) applied once-daily for two weeks
Naftin® Cream 2%
Naftin® (Naftifine Hydrochloride) Cream 2%
Naftin® (Naftifine Hydrochloride) Cream 2%
Naftin® (Naftifine Hydrochloride) Cream 2% (Merz Pharmaceuticals, LLC) applied once-daily for two weeks.
Placebo Topical Cream
Placebo Topical Cream
Placebo Topical Cream
Placebo Topical Cream (Taro Pharmaceuticals Inc.) applied once-daily for two weeks.
Interventions
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Naftifine Hydrochloride Cream 2%
Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.) applied once-daily for two weeks
Naftin® (Naftifine Hydrochloride) Cream 2%
Naftin® (Naftifine Hydrochloride) Cream 2% (Merz Pharmaceuticals, LLC) applied once-daily for two weeks.
Placebo Topical Cream
Placebo Topical Cream (Taro Pharmaceuticals Inc.) applied once-daily for two weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Sun Pharmaceutical Industries, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Catawba Research
Role: STUDY_CHAIR
http://catawbaresearch.com/contact/
Natalie Yantovskiy
Role: STUDY_DIRECTOR
Taro Pharmaceuticals USA Inc.
Other Identifiers
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NFTC 1301
Identifier Type: -
Identifier Source: org_study_id
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