Back to resultsBE Study of Naftifine HCL
Primary Purpose
Tinea Pedis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Naftifine hydrochloride 2%
Placebo
Naftin® 2% (Naftifine hydrochloride 2%)
Sponsored by
About this trial
This is an interventional treatment trial for Tinea Pedis focused on measuring Bioequivalence, Tinea pedis, Naftin
Eligibility Criteria
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
Sites / Locations
- Moore Clinical Research Inc
- Savin Medical Group Research
- International Dermatology Research, Inc,
- FXM Research Corp
- FXM Research Miramar
- South Tampa, MOORE Clinical Research, Inc.
- North Tampa MOORE Clinical Research, Inc.
- Medi Search
- Bellaire Dermatology Associates
- Research Across America
- Family Practise
- Research Across America
- Instituto Dermatológico y Cirugía de Piel
- Instituto Dermatológico
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Naftifine hydrochloride 2%
Naftin® 2% (Naftifine hydrochloride 2%)
Placebo vehicle cream.
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Mycological cure and clinical cure for a single target lesion for Trichyphyton rubrum
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.
Secondary Outcome Measures
Mycological cure and clinical cure for Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02633813
Brief Title
BE Study of Naftifine HCL
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzum Life Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Pedis
Keywords
Bioequivalence, Tinea pedis, Naftin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
693 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Naftifine hydrochloride 2%
Arm Type
Experimental
Arm Description
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.
Arm Title
Naftin® 2% (Naftifine hydrochloride 2%)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo vehicle cream.
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Naftifine hydrochloride 2%
Other Intervention Name(s)
Naftifine hcl
Intervention Description
Topical application for two weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Vehicle cream
Intervention Description
Topical application for two weeks
Intervention Type
Drug
Intervention Name(s)
Naftin® 2% (Naftifine hydrochloride 2%)
Other Intervention Name(s)
Naftifine hcl
Intervention Description
Topical application for two weeks
Primary Outcome Measure Information:
Title
Mycological cure and clinical cure for a single target lesion for Trichyphyton rubrum
Description
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.
Time Frame
week 6 + 4 days
Secondary Outcome Measure Information:
Title
Mycological cure and clinical cure for Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum
Description
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.
Time Frame
week 6 + 4 days
Other Pre-specified Outcome Measures:
Title
Assessment of AEs for each treatment groups
Description
number of adverse events reported will be collated from all the treatment arms, to evaluate the safety of the study drugs.
Time Frame
week 6 + 4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zaidoon Al-Zubaidy
Organizational Affiliation
Catawba Research
Official's Role
Study Chair
Facility Information:
Facility Name
Moore Clinical Research Inc
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Savin Medical Group Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
International Dermatology Research, Inc,
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
FXM Research Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
FXM Research Miramar
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
South Tampa, MOORE Clinical Research, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
North Tampa MOORE Clinical Research, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33618
Country
United States
Facility Name
Medi Search
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Bellaire Dermatology Associates
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Family Practise
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
Research Across America
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Instituto Dermatológico y Cirugía de Piel
City
Santo Domingo
State/Province
San Cristóbal
ZIP/Postal Code
91000
Country
Dominican Republic
Facility Name
Instituto Dermatológico
City
Barrio Maria Auxiliadora
State/Province
Santo Domingo
ZIP/Postal Code
10305
Country
Dominican Republic
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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BE Study of Naftifine HCL
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