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

NCT01580878 | Completed Phase 1

• 1 other identifier: BTNF 1104
• Study Type: interventional
• Target: 707
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Tinea Pedis

Keywords

Butenafine Hydrochloride Cream, 1%; Lotrimin Ultra® Cream, 1%; Interdigital Tinea Pedis; Safety and Bioequivalence

Outcome Measures

Primary Outcomes (1)

• Therapeutic Cure

  Subjects with both clinical cure and mycologic cure are considered therapeutic cures.

  42 days

Study Arms (3)

Butenafine Hydrochloride Cream, 1%

EXPERIMENTAL

Butenafine Hydrochloride Cream, 1% (Taro Pharmaceuticals, Inc.)

Drug: Butenafine Hydrochloride Cream, 1%

Lotrimin Ultra®

ACTIVE COMPARATOR

Lotrimin Ultra® (Butenafine Hydrochloride Cream, 1%) (Schering Plough HealthCare Products Inc.)

Drug: Lotrimin Ultra®

Butenafine Vehicle

PLACEBO COMPARATOR

Butenafine Cream vehicle (Taro Pharmaceuticals Inc.)

Drug: Butenafine Vehicle

Interventions

Butenafine Hydrochloride Cream, 1% DRUG

Butenafine Hydrochloride Cream, 1% applied twice daily for 7 consecutive days

Butenafine Hydrochloride Cream, 1%

Lotrimin Ultra® DRUG

Lotrimin Ultra® (Butenafine Hydrochloride Cream, 1%) applied twice daily for 7 consecutive days.

Lotrimin Ultra®

Butenafine Vehicle DRUG

Butenafine Vehicle applied twice daily for 7 consecutive days.

Butenafine Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

MeSH Terms

Conditions

Tinea Pedis

Interventions

butenafine

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Symbio CRO

  http://symbioresearch.com/

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2012
• First Posted: April 19, 2012
• Study Start: January 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 5, 2017

Record last verified: 2017-05