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Evaluate the Safety & Bioequivalence of a Generic Butenafine Cream & Lotrimin Ultra® & Compare Both to a Vehicle Control in Treatment of Interdigital Tinea Pedis

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ClinicalTrials.gov Identifier: NCT01580878
Recruitment Status : Completed
First Posted : April 19, 2012
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Study Description
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Brief Summary:
The primary objective of this study is to determine the comparability of the safety and efficacy of a generic Butenafine Hydrochloride Cream, 1% (test product) and Lotrimin Ultra® (the reference listed drug) in subjects with interdigital tinea pedis. It will also be determined whether the efficacy of each of the two active treatments is superior to that of the vehicle cream (placebo).

Condition or disease Intervention/treatment Phase
Tinea Pedis Drug: Butenafine Hydrochloride Cream, 1% Drug: Lotrimin Ultra® Drug: Butenafine Vehicle Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 707 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of a Generic Butenafine Hydrochloride Cream, 1% and Reference Listed Lotrimin Ultra® (Butenafine Hydrochloride Cream, 1%) and Compare Both Active Treatments to a Vehicle Control in the Treatment of Interdigital Tinea Pedis.
Study Start Date : January 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : December 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Butenafine Hydrochloride Cream, 1%
Butenafine Hydrochloride Cream, 1% (Taro Pharmaceuticals, Inc.)
 Drug: Butenafine Hydrochloride Cream, 1%
Butenafine Hydrochloride Cream, 1% applied twice daily for 7 consecutive days
Active Comparator: Lotrimin Ultra®
Lotrimin Ultra® (Butenafine Hydrochloride Cream, 1%) (Schering Plough HealthCare Products Inc.)
 Drug: Lotrimin Ultra®
Lotrimin Ultra® (Butenafine Hydrochloride Cream, 1%) applied twice daily for 7 consecutive days.
Placebo Comparator: Butenafine Vehicle
Butenafine Cream vehicle (Taro Pharmaceuticals Inc.)
 Drug: Butenafine Vehicle
Butenafine Vehicle applied twice daily for 7 consecutive days.


Outcome Measures
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Primary Outcome Measures :
  1. Therapeutic Cure [ Time Frame: 42 days ]
    Subjects with both clinical cure and mycologic cure are considered therapeutic cures.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing & able to provide & understand written informed consent
  • Healthy male or non-pregnant, non-lactating female at least 18 years of age and older
  • Clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or that is predominantly interdigital but may extend to other areas
  • Tinea pedis provisionally confirmed at baseline by positive potassium hydroxide (KOH)wet mount preparation showing segmented fungal hyphae
  • Has sum of the clinical signs and symptoms scores of the target lesion of at least 4, including a minimum score of 2 for erythema & a minimum score of 2 for scaling or pruritus
  • Currently in general good health with no clinically significant disease
  • Willing and able to understand and comply with study requirements
  • Women of childbearing potential must have a negative urine pregnancy test and be willing to use an acceptable form of birth control during study

Exclusion Criteria:

  • Females who are pregnant, breastfeeding, planning a pregnancy, or do not agree to use an acceptable form of birth control during the study
  • Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface
  • Presence of any other infection of the foot or other disease that might confound treatment evaluation
  • History of dermatophyte infections unresponsive to antifungal drugs
  • Known hypersensitivity to Butenafine Hydrochloride or any component of the study medications
  • Use of antipruritics, topical systemic corticosteroid, antibiotic or antifungal therapy, oral terbinafine or itraconazole, or immunosuppressive medication or radiation therapy more recently than indicated washout period
  • Current oral, vaginal, or mucocutaneous candidiasis
  • Current bacterial skin infection, secondary cellulitis, lymphangitis, or pyoderma
  • Presence of current conditions that require systemic antimicrobial or antifungal therapy
  • Uncontrolled diabetes mellitus, peripheral vascular disease, chronic venous stasis, or other significant condition
  • Current severe onychomycosis
  • Any clinically significant condition or situation, other than condition being studied, that would interfere with the study evaluations or participation
  • Use of any investigational drugs or device within 30 days of signing Informed Consent Form (ICF)
  • Current participation in any other clinical study
  • Consumes excessive amounts of alcohol, abuses drugs, or has any condition that would compromise compliance
  • Previous participation in this study
  • Subjects with past history of tinea pedis with lack of response to antifungal therapy
  • Subjects who in Investigator's opinion would be non-compliant
  • Employees or direct relatives of an employee of the study center or Investigator
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580878


Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
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Study Chair: Symbio CRO http://symbioresearch.com/
More Information
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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT01580878     History of Changes
Other Study ID Numbers: BTNF 1104
First Posted: April 19, 2012    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017

Keywords provided by Taro Pharmaceuticals USA:
Butenafine Hydrochloride Cream, 1%
Lotrimin Ultra® Cream, 1%
Interdigital Tinea Pedis
Safety and Bioequivalence

Additional relevant MeSH terms:
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Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms
Butenafine
Clotrimazole
 Miconazole
Antifungal Agents
Anti-Infective Agents
Anti-Infective Agents, Local
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors