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

Interdigital Tinea Pedis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01119742
• Other study ID #: BTNF-0909
• Status: Terminated
• Phase: Phase 1
• First received: May 6, 2010
• Last updated: May 5, 2014
• Start date: July 2010
• Est. completion date: July 2011

Study information

• Verified date: May 2014
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of HealthUnited States: Food and Drug Administration
• 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: Terminated
• Enrollment: 428
• Est. completion date: July 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Interdigital Tinea Pedis
• Tinea
• Tinea Pedis

Intervention

Drug:
• Butenafine Hydrochloride 1%
Twice daily application for 7 days
• Butenafine Hydrochloride 1% B
Twice daily application for 7 days
• Butenafine Hydrochloride 1%
Twice daily application for 7 days
• Vehicle A
Twice daily application for 7 days
• Vehicle B
Twice daily application for 7 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic Cure	Patients with clinical cure and mycologic cure are considered therapeutic cures.	42 Days	No
Secondary	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	No
Secondary	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	No