Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
19 October 2017 |
Main ID: |
NCT00835510 |
Date of registration:
|
30/01/2009 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis
|
Scientific title:
|
A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis |
Date of first enrolment:
|
June 2008 |
Target sample size:
|
548 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT00835510 |
Study type:
|
Interventional |
Study design:
|
|
Phase:
|
Phase 1
|
|
Countries of recruitment
|
Belize
|
United States
| | | | | | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Microbiologically confirmed clinical diagnosis of interdigital tinea pedis
- If female and of child bearing potential, prepare to abstain from sexual intercourse
or use a reliable method of contraception during the study (e.g., condom,
intra-uterine device (IUD), oral, transdermal, injected or implanted hormonal
contraceptives).
- A confirmed clinical diagnosis of interdigital tinea pedis. Lesions are to be
predominately interdigital but may extend to other areas of the foot (the
non-interdigital lesions must not be hyperkeratotic).
- The presence of tinea pedis infection, confirmed by the observation of segmented
fungal hyphae during a microscopic potassium hydroxide (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
mentagrophyte or Epidermophyton floccosum.
Exclusion Criteria:
- Use of any of the following within the indicated timeline:
- Oral or injectable steroids
- 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 over-the-counter (OTC) topical antifungals 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 Investigator's
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.
Age minimum:
12 Years
Age maximum:
N/A
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Tinea Pedis
|
Intervention(s)
|
Drug: Butenafine cream 1% manufactured by Taro
|
Drug: Butenafine Vehicle manufactured by Taro
|
Drug: Lotrimin Ultra (butenafine) 1%
|
Primary Outcome(s)
|
Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra
[Time Frame: 42 days]
|
Therapeutic Cure - Superiority Analysis
[Time Frame: 42 days]
|
Secondary Outcome(s)
|
Clinical Cure
[Time Frame: 42 days]
|
Mycologic Cure
[Time Frame: 42 days]
|
Therapeutic Cure
[Time Frame: 7 days]
|
Safety and Adverse Event Profile
[Time Frame: 42 days]
|
Secondary ID(s)
|
BTNF-0708
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
|