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Butenafine

Generic Name
Butenafine
Brand Names
Lotrimin Ultra
Drug Type
Small Molecule
Chemical Formula
C23H27N
CAS Number
101828-21-1
Unique Ingredient Identifier
91Y494NL0X
Background

Butenafine hydrochloride is a synthetic benzylamine antifungal agent. Butenafine's mechanism of action is believed to involve the synthesis inhibition of sterols. In particular, butenafine acts to inhibit the activity of the squalene epoxidase enzyme that is essential in the formation of sterols necessary for fungal cell membranes.

Indication

For the topical treatment of the following dermatologic infections: tinea (pityriasis) versicolor due to M. furfur, interdigital tinea pedis (athlete’s foot), tinea corporis (ringworm) and tinea cruris (jock itch) due to E. floccosum, T. mentagrophytes, T. rubrum, and T. tonsurans.

Associated Conditions
Pityriasis versicolor, Tinea Corporis, Tinea Cruris, Tinea Pedis
Clinical Trials
Related News

Study to Determine Skin Irritation Potential of an Antifungal Cream Containing Trolamine After Repeated Skin Application (Cumulative Irritation Patch Test)

Phase 3
Completed
Conditions
Hypersensitivity
Interventions
Drug: Positive Control-Sodium lauryl sulfate (SLS)
Other: Negative Control
First Posted Date
2020-08-31
Last Posted Date
2020-09-25
Lead Sponsor
Bayer
Target Recruit Count
32
Registration Number
NCT04531813

Study to Find Out if Cream V61-044 Used to Treat Fungal Infections Causes an Allergic Skin Reaction to Sunlight in Healthy Participants

First Posted Date
2020-08-31
Last Posted Date
2020-11-16
Lead Sponsor
Bayer
Target Recruit Count
137
Registration Number
NCT04532164

Study to Learn More About the Potential of Antifungal Cream V61-044 Containing Trolamine to Cause Irritant Reaction of the Skin to Ultra Violet Light in Healthy Human Subjects

Phase 3
Completed
Conditions
Dermatitis, Phototoxic
Interventions
First Posted Date
2020-08-28
Last Posted Date
2020-11-13
Lead Sponsor
Bayer
Target Recruit Count
32
Registration Number
NCT04531527

Study to Determine Skin Irritation and/or Sensitization Potential of an Antifungal Cream Containing Trolamine (Repeated Insult Patch Test)

Phase 3
Completed
Conditions
Hypersensitivity
Interventions
First Posted Date
2020-08-28
Last Posted Date
2020-11-17
Lead Sponsor
Bayer
Target Recruit Count
225
Registration Number
NCT04531540

SINGLE-APPLICATION TERBINAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION VERSUS A SINGLE-APPLICATION BUTENAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION FOR THE TREATMENT OF TINEA PEDIS

Phase 2
Conditions
Tinea Pedis
Interventions
Drug: Vehicle Control
First Posted Date
2019-06-26
Last Posted Date
2019-06-26
Lead Sponsor
United Laboratories
Target Recruit Count
42
Registration Number
NCT03999437
Locations
🇵🇭

Clinical Trial Management and Testing Associates, Inc., Muntinlupa, Philippines

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

First Posted Date
2012-04-19
Last Posted Date
2017-05-05
Lead Sponsor
Taro Pharmaceuticals USA
Target Recruit Count
707
Registration Number
NCT01580878

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

Phase 1
Terminated
Conditions
Interdigital Tinea Pedis
Interventions
Drug: Vehicle A
Drug: Vehicle B
First Posted Date
2010-05-10
Last Posted Date
2014-05-06
Lead Sponsor
Taro Pharmaceuticals USA
Target Recruit Count
428
Registration Number
NCT01119742

Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis

First Posted Date
2009-02-03
Last Posted Date
2014-02-04
Lead Sponsor
Taro Pharmaceuticals USA
Target Recruit Count
548
Registration Number
NCT00835510
Locations
🇧🇿

Investigator Site, Belize City, Belize

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