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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00835510
Other study ID # BTNF-0708
Secondary ID
Status Completed
Phase Phase 1
First received January 30, 2009
Last updated January 2, 2014
Start date June 2008
Est. completion date December 2008

Study information

Verified date January 2014
Source Taro Pharmaceuticals USA
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 548
Est. completion date December 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Butenafine cream 1% manufactured by Taro
Treatment applied to affected area twice daily for 7 days
Lotrimin Ultra (butenafine) 1%
Treatment applied to affected area twice daily for 7 days
Butenafine Vehicle manufactured by Taro
Treatment applied to affected area twice daily for 7 days

Locations

Country Name City State
Belize Investigator Site Belize City
United States Investigator Site Bristol Tennessee
United States Investigator Site Burbank California
United States Investigator Site Clinton Township Michigan
United States Investigator Site College Station Texas
United States Investigator Site Hickory North Carolina
United States Investigator Site Houston Texas
United States Investigator Site Martinez Georgia
United States Investigator Site Miami Florida
United States Investigator Site Nashville Tennessee
United States Investigator Site Raleigh North Carolina
United States Investigator Site Salisbury North Carolina
United States Investigator Site San Antonio Texas
United States Investigator Site San Diego California
United States Investigator Site Simpsonville South Carolina
United States Investigator Site Stockbridge Georgia
United States Investigator Site Sylvania Ohio

Sponsors (1)

Lead Sponsor Collaborator
Taro Pharmaceuticals USA

Countries where clinical trial is conducted

United States,  Belize, 

Outcome

Type Measure Description Time frame Safety issue
Primary Therapeutic Cure - Superiority Analysis Therapeutic Cure requires both Clinical Cure and Mycological Cure.
Clinical Cure was based on the following signs and symptoms: fissuring, erythema, maceration, vesiculation, scaling, exudation, pruritus, burning. Each clinical symptom was evaluated using a 0-3 point rating scale: none=0, mild=1, moderate=2 or severe=3. If the score for erythema was = 2 and the sum for all of the other 7 signs and symptoms was <2 then the patient was considered a Clinical Cure.
Mycological Cure: The potassium hydroxide (KOH) and the fungal culture were both negative.
42 days No
Primary Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra Patient was cured both by symptoms (Clinical Cure) and by the results of fungal testing (Mycological Cure). 42 days No
Secondary Therapeutic Cure Subject with clinical and mycological cure at day 7 7 days No
Secondary Mycologic Cure Negative KOH and fungal culture at day 42 42 days No
Secondary Clinical Cure The following 8 signs and symptoms are rated at each visit:
Erythema Fissuring Maceration Vesiculation Desquamation/scaling Exudation Pruritus Stinging/Burning
Each symptom is evaluated using the following scale:
0 = None- Complete absence of any sign or symptom
= Mild - obvious but minimal involvement
= Moderate - something that is easily noted
= Severe - quite marked
Clinical cure is defined as a score of 2 (moderate) or less for erythema and a total score for seven other signs and symptoms less than 2.
42 days No
Secondary Safety and Adverse Event Profile 42 days Yes
See also
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