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

Taro Pharmaceuticals

Status and phase: Terminated; Phase 1

Conditions: Interdigital Tinea Pedis

Treatments: Drug: Vehicle A; Drug: Butenafine Hydrochloride 1% B; Drug: Butenafine Hydrochloride 1%; Drug: Vehicle B

Study type: Interventional

Funder types: Industry

Identifiers

NCT01119742

BTNF-0909

Details and patient eligibility

About

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).

Enrollment: 428 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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428 participants in 5 patient groups, including a placebo group

Butenafine Hydrochloride 1% A

Experimental group

Description:

1

Treatment:

Drug: Butenafine Hydrochloride 1%

Drug: Butenafine Hydrochloride 1%

Butenafine Hydrochloride 1% B

Experimental group

Description:

2

Treatment:

Drug: Butenafine Hydrochloride 1% B

Butenafine Hydrochloride 1%

Active Comparator group

Description:

3

Treatment:

Drug: Butenafine Hydrochloride 1%

Drug: Butenafine Hydrochloride 1%

Vehicle A

Placebo Comparator group

Description:

4

Treatment:

Drug: Vehicle A

Vehicle B

Placebo Comparator group

Description:

5

Treatment:

Drug: Vehicle B