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

Arm | Intervention/treatment |
---|---|
Experimental: Butenafine Hydrochloride Cream, 1%
Butenafine Hydrochloride Cream, 1% (Taro Pharmaceuticals, Inc.)
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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.)
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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. |
- Therapeutic Cure [ Time Frame: 42 days ]Subjects with both clinical cure and mycologic cure are considered therapeutic cures.

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

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
Study Chair: | Symbio CRO | http://symbioresearch.com/ |
Responsible Party: | Taro Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT01580878 |
Other Study ID Numbers: |
BTNF 1104 |
First Posted: | April 19, 2012 Key Record Dates |
Last Update Posted: | May 5, 2017 |
Last Verified: | May 2017 |
Butenafine Hydrochloride Cream, 1% Lotrimin Ultra® Cream, 1% Interdigital Tinea Pedis Safety and Bioequivalence |
Tinea Tinea Pedis Dermatomycoses Mycoses Bacterial Infections and Mycoses Infections Skin Diseases, Infectious Skin Diseases Foot Dermatoses Foot Diseases Pruritus Skin Manifestations Butenafine |
Clotrimazole 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 |