Back to resultsClinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams as Compared to Lotrimin Ultra Cream in Patients With Interdigital Tinea Pedis (BNF-0909)
Primary Purpose
Interdigital Tinea Pedis
Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Butenafine Hydrochloride 1%
Butenafine Hydrochloride 1% B
Butenafine Hydrochloride 1%
Vehicle A
Vehicle B
Sponsored by
About this trial
This is an interventional treatment trial for Interdigital Tinea Pedis focused on measuring Tinea Pedis, Interdigital
Eligibility Criteria
Inclusion Criteria:
- Male or non-pregnant, non lactating females 18 years of age or older.
- Signed informed consent form, which meets all criteria of current FDA regulations and the requirements of the India regulatory authorities.
- If female and of child bearing potential, have a negative urine pregnancy test at the baseline visit,
- A total score of at least six (6) for the following eight (8) clinical signs and symptoms of interdigital tinea pedis: fissuring, erythema, maceration, vesiculation, desquamation/scaling, exudation, pruritus, burning/stinging. In addition the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for either pruritus or desquamation/scaling
- A confirmed clinical diagnosis of interdigital tinea pedis.
- The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic KOH wet mount examination (potassium hydroxide mount preparation).
- Identification of an appropriate dermatophyte by culture sent to the central laboratory. The appropriate dermatophytes are Trichophyton rubrum, Trichophyton mentagrophytes or Epidermophyton floccosum.
Exclusion Criteria:
Use of any of the following within the indicated timeline:
- Oral or injectable steroids within four weeks of the study start.
- Any oral anti-fungals within 4 weeks of the study start.
- Use of topical corticosteroids or any other topical antipruritics on the feet within 72 hours of the study start.
- Any prescription or OTC topical antifungal on the feet within two weeks prior to study entry.
- Use of any antihistamines within 72 hours of the study start.
- Any known hypersensitivity to butenafine or other antifungal agents.
- Evidence of any concurrent dermatophytic infection of toe nails (onychomycosis) or other dermatological condition of the foot that may interfere with the Investigators evaluation of tinea pedis.
- Patients with recurrent tinea pedis (more than 3 infections in the past 12 months) who have been unresponsive to previous antifungal therapy.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Placebo Comparator
Arm Label
Butenafine Hydrochloride 1% A
Butenafine Hydrochloride 1% B
Butenafine Hydrochloride 1%
Vehicle A
Vehicle B
Arm Description
1
2
3
4
5
Outcomes
Primary Outcome Measures
Therapeutic Cure
Patients with clinical cure and mycologic cure are considered therapeutic cures.
Secondary Outcome Measures
Clinical Cure
Patient will be considered a "clincal cure" if the score for erythema is equal or less than 2 and the total score for all of the other seven signs and symptoms is less than 2.
Mycologic Cure
Patient will be considered a "mycological cure" if the results of both the potassium hydroxide (KOH) and the fungal culture are negative.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01119742
Brief Title
Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams as Compared to Lotrimin Ultra Cream in Patients With Interdigital Tinea Pedis
Acronym
BNF-0909
Official Title
A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams to Lotrimin Ultra® Cream in Patients With Interdigital Tinea Pedis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Insufficient number of baseline eligible patient
Study Start Date
July 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To demonstrate comparable safety and efficacy of Taro Pharmaceuticals, Inc butenafine hydrochloride cream 1% test product and Lotrimin Ultra cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interdigital Tinea Pedis
Keywords
Tinea Pedis, Interdigital
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
428 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Butenafine Hydrochloride 1% A
Arm Type
Experimental
Arm Description
1
Arm Title
Butenafine Hydrochloride 1% B
Arm Type
Experimental
Arm Description
2
Arm Title
Butenafine Hydrochloride 1%
Arm Type
Active Comparator
Arm Description
3
Arm Title
Vehicle A
Arm Type
Placebo Comparator
Arm Description
4
Arm Title
Vehicle B
Arm Type
Placebo Comparator
Arm Description
5
Intervention Type
Drug
Intervention Name(s)
Butenafine Hydrochloride 1%
Intervention Description
Twice daily application for 7 days
Intervention Type
Drug
Intervention Name(s)
Butenafine Hydrochloride 1% B
Intervention Description
Twice daily application for 7 days
Intervention Type
Drug
Intervention Name(s)
Butenafine Hydrochloride 1%
Other Intervention Name(s)
Lotrimin Ultra Cream
Intervention Description
Twice daily application for 7 days
Intervention Type
Drug
Intervention Name(s)
Vehicle A
Intervention Description
Twice daily application for 7 days
Intervention Type
Drug
Intervention Name(s)
Vehicle B
Intervention Description
Twice daily application for 7 days
Primary Outcome Measure Information:
Title
Therapeutic Cure
Description
Patients with clinical cure and mycologic cure are considered therapeutic cures.
Time Frame
42 Days
Secondary Outcome Measure Information:
Title
Clinical Cure
Description
Patient will be considered a "clincal cure" if the score for erythema is equal or less than 2 and the total score for all of the other seven signs and symptoms is less than 2.
Time Frame
42 days
Title
Mycologic Cure
Description
Patient will be considered a "mycological cure" if the results of both the potassium hydroxide (KOH) and the fungal culture are negative.
Time Frame
42 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or non-pregnant, non lactating females 18 years of age or older.
Signed informed consent form, which meets all criteria of current FDA regulations and the requirements of the India regulatory authorities.
If female and of child bearing potential, have a negative urine pregnancy test at the baseline visit,
A total score of at least six (6) for the following eight (8) clinical signs and symptoms of interdigital tinea pedis: fissuring, erythema, maceration, vesiculation, desquamation/scaling, exudation, pruritus, burning/stinging. In addition the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for either pruritus or desquamation/scaling
A confirmed clinical diagnosis of interdigital tinea pedis.
The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic KOH wet mount examination (potassium hydroxide mount preparation).
Identification of an appropriate dermatophyte by culture sent to the central laboratory. The appropriate dermatophytes are Trichophyton rubrum, Trichophyton mentagrophytes or Epidermophyton floccosum.
Exclusion Criteria:
Use of any of the following within the indicated timeline:
Oral or injectable steroids within four weeks of the study start.
Any oral anti-fungals within 4 weeks of the study start.
Use of topical corticosteroids or any other topical antipruritics on the feet within 72 hours of the study start.
Any prescription or OTC topical antifungal on the feet within two weeks prior to study entry.
Use of any antihistamines within 72 hours of the study start.
Any known hypersensitivity to butenafine or other antifungal agents.
Evidence of any concurrent dermatophytic infection of toe nails (onychomycosis) or other dermatological condition of the foot that may interfere with the Investigators evaluation of tinea pedis.
Patients with recurrent tinea pedis (more than 3 infections in the past 12 months) who have been unresponsive to previous antifungal therapy.
12. IPD Sharing Statement
Learn more about this trial
Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams as Compared to Lotrimin Ultra Cream in Patients With Interdigital Tinea Pedis
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