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
PHASE3
693 participants
INTERVENTIONAL
2015-03-31
2015-12-31
Brief Summary
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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).
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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 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.
Naftifine hydrochloride 2%
Topical application for two weeks
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.
Naftin® 2% (Naftifine hydrochloride 2%)
Topical application for two weeks
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.
Placebo
Topical application for two weeks
Interventions
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Naftifine hydrochloride 2%
Topical application for two weeks
Placebo
Topical application for two weeks
Naftin® 2% (Naftifine hydrochloride 2%)
Topical application for two weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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)
3. 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
2. Use of antipruritics, including antihistamines, within 72 hours prior to entry into the study
3. Use of topical corticosteroid, antibiotics or antifungal therapy within 2 weeks prior to entry into the study
4. Use of systemic (e.g., oral or injectable) corticosteroid, antibiotics or antifungal therapy within 1 month prior to entry into the study
5. Use of oral terbinafine or itraconazole within 2 months prior to entry into the study
6. Use of immunosuppressive medication or radiation therapy within 3 months prior to entry into the study.
7. Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
8. Presence of any other infection of the foot or other disease process that might confound the treatment evaluation
9. History of dermatophyte infections unresponsive to systemic or topical antifungal drugs
10. Known hypersensitivity to Naftifine Hydrochloride or to any component of the formulation
18 Years
ALL
No
Sponsors
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Genzum Life Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Zaidoon Al-Zubaidy
Role: STUDY_CHAIR
Catawba Research
Locations
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Moore Clinical Research Inc
Brandon, Florida, United States
Savin Medical Group Research
Miami, Florida, United States
International Dermatology Research, Inc,
Miami, Florida, United States
FXM Research Corp
Miami, Florida, United States
FXM Research Miramar
Miramar, Florida, United States
South Tampa, MOORE Clinical Research, Inc.
Tampa, Florida, United States
North Tampa MOORE Clinical Research, Inc.
Tampa, Florida, United States
Medi Search
Saint Joseph, Missouri, United States
Bellaire Dermatology Associates
Bellaire, Texas, United States
Research Across America
Dallas, Texas, United States
Family Practise
Mesquite, Texas, United States
Research Across America
Plano, Texas, United States
Instituto Dermatológico y Cirugía de Piel
Santo Domingo, San Cristóbal, Dominican Republic
Instituto Dermatológico
Barrio Maria Auxiliadora, Santo Domingo Province, Dominican Republic
Countries
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Other Identifiers
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CD-13-661
Identifier Type: -
Identifier Source: org_study_id
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