- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02633813
BE Study of Naftifine HCL
A Randomized, Prospective Multicenter, Double Blind, Parallel Assignment Placebo Controlled BE Study Of Naftifine Hydrochloride 2% Topical Cream With Naftin® In Patients With Tinea Pedis Using Clinical Endpoints
The current study was randomized, double blind, placebo-controlled, prospective, multicenter, comparative therapeutic equivalence study.
The study duration for each patient was 6 weeks: Following were the visit details.
V1-Baseline and Randomization Visit (Day 1). V2- End of therapy visit (at the end of week 2 + 2 days). V3- Follow up visit (at the end of week 4 + 2 days). V4 - Test of cure visit ( at the end of week 6 + 4 days).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
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San Cristóbal
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Santo Domingo, San Cristóbal, Dominican Republic, 91000
- Instituto Dermatologico y Cirugia de Piel
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Santo Domingo
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Barrio Maria Auxiliadora, Santo Domingo, Dominican Republic, 10305
- Instituto Dermatológico
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-
-
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Florida
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Brandon, Florida, United States, 33511
- Moore Clinical Research Inc
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Miami, Florida, United States, 33175
- FXM Research Corp
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Miami, Florida, United States, 33014
- Savin Medical Group Research
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Miami, Florida, United States, 33144
- International Dermatology Research, Inc,
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Miramar, Florida, United States, 33027
- FXM Research Miramar
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Tampa, Florida, United States, 33609
- South Tampa, MOORE Clinical Research, Inc.
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Tampa, Florida, United States, 33618
- North Tampa MOORE Clinical Research, Inc.
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Missouri
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Saint Joseph, Missouri, United States, 64506
- Medi Search
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Texas
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Bellaire, Texas, United States, 77401
- Bellaire Dermatology Associates
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Dallas, Texas, United States, 75234
- Research Across America
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Mesquite, Texas, United States, 75149
- Family Practise
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Plano, Texas, United States, 75093
- Research Across America
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy males and females aged more than or equal to 18 years
- 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 non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin), and provisionally confirmed at baseline by a positive potassium hydroxide (KOH) wet mount preparation (i.e., skin scrapings from the target site are placed on a microscope slide with a drop of 10% KOH, and microscopic examination reveals segmented fungal hyphae)
- 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 (on a scale of 0-3, where 2 indicates moderate severity)
Exclusion Criteria:
- Pregnant or lactating or planning to become pregnant during the study period
- Use of antipruritics, including antihistamines, within 72 hours prior to entry into the study
- Use of topical corticosteroid, antibiotics or antifungal therapy within 2 weeks prior to entry into the study
- Use of systemic (e.g., oral or injectable) corticosteroid, antibiotics or antifungal therapy within 1 month prior to entry into the study
- Use of oral terbinafine or itraconazole within 2 months prior to entry into the study
- Use of immunosuppressive medication or radiation therapy within 3 months prior to entry into the study.
- Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
- Presence of any other infection of the foot or other disease process that might confound the treatment evaluation
- History of dermatophyte infections unresponsive to systemic or topical antifungal drugs
- Known hypersensitivity to Naftifine Hydrochloride or to any component of the formulation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Naftifine hydrochloride 2%
A thin layer of sufficient quantity of Naftifine hydrochloride cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks.
|
Topical application for two weeks
Other Names:
|
Active Comparator: Naftin® 2% (Naftifine hydrochloride 2%)
A thin layer of sufficient quantity of Naftifine hydrochloride cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks.
|
Topical application for two weeks
Other Names:
|
Placebo Comparator: Placebo vehicle cream.
A thin layer of sufficient quantity of vehicle cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks.
|
Topical application for two weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mycological cure and clinical cure for a single target lesion for Trichyphyton rubrum
Time Frame: week 6 + 4 days
|
After 6 weeks the skin scrapping will be collected for culture to find out the growth of T rubrum.
Absence of growth suggests complete cure.
|
week 6 + 4 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mycological cure and clinical cure for Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum
Time Frame: week 6 + 4 days
|
After 6 weeks the skin scrapping will be collected for culture to find out the growth of T rubrum, T Mentagrophytes or E floccosum.
Absence of growth suggests complete cure.
|
week 6 + 4 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of AEs for each treatment groups
Time Frame: week 6 + 4 days
|
number of adverse events reported will be collated from all the treatment arms, to evaluate the safety of the study drugs.
|
week 6 + 4 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Zaidoon Al-Zubaidy, Catawba Research
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CD-13-661
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Naftifine hydrochloride 2%
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-
Taro Pharmaceuticals USACompleted
-
Merz North America, Inc.CompletedTinea Pedis | Tinea CrurisHonduras, United States, Dominican Republic
-
Merz North America, Inc.Withdrawn
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Therapeutics, Inc.CompletedTinea Pedis | Tinea CrurisUnited States
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MediQuest TherapeuticsCompleted
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Taro Pharmaceuticals USACompleted
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Merz North America, Inc.CompletedTinea PedisUnited States
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Merz North America, Inc.CompletedTinea CorporisUnited States, Dominican Republic, Honduras
-
Betta Pharmaceuticals Co., Ltd.Quintiles, Inc.Completed