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

Phase 1

Terminated

• Conditions: Interdigital Tinea Pedis
• Interventions: Drug: Butenafine Hydrochloride 1%; Drug: Butenafine Hydrochloride 1% B; Drug: Vehicle A; Drug: Vehicle B

• Registration Number: NCT01119742
• Lead Sponsor: Taro Pharmaceuticals USA

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-06
• Study First Submitted QC: 2010-05-06
• Study First Posted: 2010-05-10
• Study Start: 2010-07
• Primary Completion: 2011-03
• Study Completion: 2011-07
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-05
• Last Update Posted: 2014-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 428

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Butenafine Hydrochloride 1% A	Butenafine Hydrochloride 1%	1
Butenafine Hydrochloride 1% B	Butenafine Hydrochloride 1% B	2
Butenafine Hydrochloride 1%	Butenafine Hydrochloride 1%	3
Vehicle A	Vehicle A	4
Vehicle B	Vehicle B	5

Primary Outcome Measures

Name	Time	Method
Therapeutic Cure	42 Days	Patients with clinical cure and mycologic cure are considered therapeutic cures.

Secondary Outcome Measures

Name	Time	Method
Clinical Cure	42 days	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	42 Days	Patient will be considered a "mycological cure" if the results of both the potassium hydroxide (KOH) and the fungal culture are negative.