Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams as Compared to Lotrimin Ultra Cream in Patients With Interdigital Tinea Pedis (BNF-0909)

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

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).

Study Overview

• Status: Terminated
• Conditions: Interdigital Tinea Pedis
• Intervention / Treatment: Drug: Butenafine Hydrochloride 1%; Drug: Butenafine Hydrochloride 1% B; Drug: Vehicle A; Drug: Vehicle B

• Study Type: Interventional
• Enrollment (Actual): 428
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or non-pregnant, non lactating females 18 years of age or older.
2. Signed informed consent form, which meets all criteria of current FDA regulations and the requirements of the India regulatory authorities.
3. If female and of child bearing potential, have a negative urine pregnancy test at the baseline visit,
4. 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
5. A confirmed clinical diagnosis of interdigital tinea pedis.
6. 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).
7. 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:

1. 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.
2. Any known hypersensitivity to butenafine or other antifungal agents.
3. 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.
4. Patients with recurrent tinea pedis (more than 3 infections in the past 12 months) who have been unresponsive to previous antifungal therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Butenafine Hydrochloride 1% A; 1	Drug: Butenafine Hydrochloride 1%; Twice daily application for 7 days; Other Names: Lotrimin Ultra Cream
Experimental: Butenafine Hydrochloride 1% B; 2	Drug: Butenafine Hydrochloride 1% B; Twice daily application for 7 days
Active Comparator: Butenafine Hydrochloride 1%; 3	Drug: Butenafine Hydrochloride 1%; Twice daily application for 7 days; Other Names: Lotrimin Ultra Cream
Placebo Comparator: Vehicle A; 4	Drug: Vehicle A; Twice daily application for 7 days
Placebo Comparator: Vehicle B; 5	Drug: Vehicle B; Twice daily application for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic Cure	Patients with clinical cure and mycologic cure are considered therapeutic cures.	42 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	42 days
Mycologic Cure	Patient will be considered a "mycological cure" if the results of both the potassium hydroxide (KOH) and the fungal culture are negative.	42 Days

Collaborators and Investigators

• Sponsor: Taro Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: May 6, 2010
• First Submitted That Met QC Criteria: May 6, 2010
• First Posted (Estimate): May 10, 2010

Study Record Updates

• Last Update Posted (Estimate): May 6, 2014
• Last Update Submitted That Met QC Criteria: May 5, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Tinea Pedis; Interdigital
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Foot Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Skin Manifestations; Dermatomycoses; Foot Dermatoses; Pruritus; Tinea; Tinea Pedis; Anti-Infective Agents; Antifungal Agents; Butenafine
• Other Study ID Numbers: BTNF-0909