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

This study has been terminated.
(Insufficient number of baseline eligible patient)
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01119742
First received: May 6, 2010
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention Phase
Interdigital Tinea Pedis
Drug: Butenafine Hydrochloride 1%
Drug: Butenafine Hydrochloride 1% B
Drug: Vehicle A
Drug: Vehicle B
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Taro Pharmaceuticals USA:

Primary Outcome Measures:
  • Therapeutic Cure [ Time Frame: 42 Days ] [ Designated as safety issue: No ]
    Patients with clinical cure and mycologic cure are considered therapeutic cures.


Secondary Outcome Measures:
  • Clinical Cure [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 42 Days ] [ Designated as safety issue: No ]
    Patient will be considered a "mycological cure" if the results of both the potassium hydroxide (KOH) and the fungal culture are negative.


Enrollment: 428
Study Start Date: July 2010
Study Completion Date: July 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Butenafine Hydrochloride 1% A
1
Drug: Butenafine Hydrochloride 1%
Twice daily application for 7 days
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 Name: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT01119742     History of Changes
Other Study ID Numbers: BTNF-0909
Study First Received: May 6, 2010
Last Updated: May 5, 2014
Health Authority: India: Ministry of Health
United States: Food and Drug Administration

Keywords provided by Taro Pharmaceuticals USA:
Tinea Pedis
Interdigital

Additional relevant MeSH terms:
Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms
Butenafine
Miconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014