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Last Updated: March 14, 2025

CLINICAL TRIALS PROFILE FOR BUTENAFINE HYDROCHLORIDE


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All Clinical Trials for butenafine hydrochloride

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT03999437 ↗ SINGLE-APPLICATION TERBINAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION VERSUS A SINGLE-APPLICATION BUTENAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION FOR THE TREATMENT OF TINEA PEDIS Unknown status United Laboratories Phase 2 2019-01-02 Tinea pedis or athlete's foot is the most common fungal infection worldwide, caused by infection of the feet with dermatophytes such as Trichophyton rubrum, Trichophyton interdigitale (formerly Trichophyton mentagrophytes), and Epidermophyton floccosum. Diagnosis of tinea pedia involves clinical symptoms as well as microscopic examination. Topical therapies are usually applied once or twice daily for as long as 4 weeks, posing a challenge to compliance. The current study aims to test a formulation of the single-dose 1% terbinafine hydrochloride, as well as a single-dose 1% butenafine hydrochloride, versus a vehicle control in adult Filipino patients with athlete's foot. This study will benefit the Filipino community by helping us determine which anti-fungal cream is most effective for athlete's foot.
NCT01580878 ↗ Evaluate the Safety & Bioequivalence of a Generic Butenafine Cream & Lotrimin Ultra® & Compare Both to a Vehicle Control in Treatment of Interdigital Tinea Pedis Completed Taro Pharmaceuticals USA Phase 1 2012-01-01 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).
NCT01119742 ↗ Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams as Compared to Lotrimin Ultra Cream in Patients With Interdigital Tinea Pedis Terminated Taro Pharmaceuticals USA Phase 1 2010-07-01 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).
NCT00835510 ↗ Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis Completed Taro Pharmaceuticals USA Phase 1 2008-06-01 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).
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for butenafine hydrochloride

Condition Name

31000.511.522.53Tinea PedisInterdigital Tinea Pedis[disabled in preview]
Condition Name for butenafine hydrochloride
Intervention Trials
Tinea Pedis 3
Interdigital Tinea Pedis 1
[disabled in preview] 0
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Condition MeSH

44000.511.522.533.54Tinea PedisTinea[disabled in preview]
Condition MeSH for butenafine hydrochloride
Intervention Trials
Tinea Pedis 4
Tinea 4
[disabled in preview] 0
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Clinical Trial Locations for butenafine hydrochloride

Trials by Country

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Trials by Country for butenafine hydrochloride
Location Trials
United States 9
Belize 1
Philippines 1
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Trials by US State

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Trials by US State for butenafine hydrochloride
Location Trials
Texas 1
Tennessee 1
South Carolina 1
Ohio 1
North Carolina 1
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Clinical Trial Progress for butenafine hydrochloride

Clinical Trial Phase

25.0%75.0%000.511.522.53Phase 2Phase 1[disabled in preview]
Clinical Trial Phase for butenafine hydrochloride
Clinical Trial Phase Trials
Phase 2 1
Phase 1 3
[disabled in preview] 0
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Clinical Trial Status

50.0%25.0%25.0%0-0.200.20.40.60.811.21.41.61.822.2CompletedTerminatedUnknown status[disabled in preview]
Clinical Trial Status for butenafine hydrochloride
Clinical Trial Phase Trials
Completed 2
Terminated 1
Unknown status 1
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Clinical Trial Sponsors for butenafine hydrochloride

Sponsor Name

trials0112233Taro Pharmaceuticals USAUnited Laboratories[disabled in preview]
Sponsor Name for butenafine hydrochloride
Sponsor Trials
Taro Pharmaceuticals USA 3
United Laboratories 1
[disabled in preview] 0
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Sponsor Type

100.0%000.511.522.533.54Industry[disabled in preview]
Sponsor Type for butenafine hydrochloride
Sponsor Trials
Industry 4
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Butenafine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Butenafine hydrochloride is an antifungal agent that has gained significant attention for its efficacy in treating various fungal infections, including tinea cruris, tinea corporis, and interdigital tinea pedis. This article delves into the clinical trials, market analysis, and future projections for butenafine hydrochloride.

Clinical Trials and Efficacy

Comparison with Clotrimazole

A randomized controlled trial compared the efficacy of butenafine with clotrimazole in treating tinea cruris and tinea corporis. The study involved 75 patients, with 37 in the butenafine group and 38 in the clotrimazole group. Butenafine was applied once daily for 2 weeks, while clotrimazole was applied twice daily for 4 weeks. The results showed that both treatments were highly effective, with a reduction of 81.5% in the sign and symptom score for butenafine and 85.93% for clotrimazole at 4 weeks post-treatment. There was no statistically significant difference between the two groups, indicating that butenafine is as effective as clotrimazole but requires a simpler and shorter treatment regimen[1].

Clinical Equivalence of Generic Butenafine Hydrochloride

Another clinical trial aimed to demonstrate the clinical equivalence of two generic butenafine hydrochloride 1% creams compared to Lotrimin Ultra cream in patients with interdigital tinea pedis. Although the trial was terminated, it was designed to show the safety and efficacy of the generic products, highlighting the potential for generic formulations to be as effective as branded products[4].

Formulation and Optimization

Recent studies have focused on optimizing the formulation of butenafine hydrochloride to enhance its delivery and efficacy. A study on the formulation and optimization of butenafine-loaded topical nanostructured lipid carriers (NLCs) showed promising results. The optimized formulation had a particle size of 111 nm and high entrapment efficiency of 86.35%. When converted into a gel, it demonstrated ideal gel evaluation results, including prolonged drug release and high drug permeation with minimal skin irritation[3].

Market Analysis

Current Market Size and Growth

The butenafine hydrochloride market has experienced significant growth in recent years. As of 2023, the market size was substantial, and projections indicate that it will continue to grow robustly until 2031. The market is segmented based on type (purity levels such as 98% and 99%) and application (medicine, chemical, and other uses), as well as geographical regions[2][5].

Market Segments and Trends

The market is categorized into various segments, including different purity levels and applications. The report highlights that the market dynamics are influenced by factors such as product pricing, market penetration, and consumer behavior. The thorough segmentation ensures a comprehensive analysis from various angles, including end-use industries, key players, and economic, political, and social landscapes[2][5].

Drivers and Challenges

The market growth is driven by several factors, including the increasing prevalence of fungal infections, the efficacy of butenafine hydrochloride, and the convenience of its application regimen. However, the market also faces challenges such as competition from other antifungal agents and regulatory hurdles. The report conducts an in-depth analysis of Porter's 5 Forces Framework, macroeconomic evaluation, and value chain scrutiny to understand these dynamics[2][5].

Market Projections

Forecasted Growth

The butenafine hydrochloride market is anticipated to attain significant growth by the end of 2031. The positive momentum in market dynamics and the expected sustained expansion indicate robust growth rates over the forecasted period. The market is poised for noteworthy development, driven by increasing demand and advancements in formulation technology[2][5].

Geographical Insights

The market growth is expected to be robust across various geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. The report provides detailed insights into the market size and predictions for each region, highlighting the potential for growth and investment opportunities[2][5].

Key Takeaways

  • Efficacy and Convenience: Butenafine hydrochloride has been shown to be as effective as clotrimazole in treating fungal infections, with the advantage of a simpler and shorter treatment regimen.
  • Optimized Formulations: Recent studies have optimized the formulation of butenafine hydrochloride, enhancing its delivery and reducing skin irritation.
  • Market Growth: The butenafine hydrochloride market is experiencing significant growth and is projected to continue this trend until 2031.
  • Segmentation and Trends: The market is segmented based on type, application, and geographical regions, with various factors influencing its dynamics.
  • Drivers and Challenges: The market is driven by the increasing prevalence of fungal infections and the efficacy of butenafine hydrochloride, but faces challenges such as competition and regulatory hurdles.

FAQs

What is butenafine hydrochloride used for?

Butenafine hydrochloride is an antifungal agent used to treat various fungal infections, including tinea cruris, tinea corporis, and interdigital tinea pedis.

How does butenafine hydrochloride compare to clotrimazole?

Butenafine hydrochloride has been shown to be as effective as clotrimazole in treating fungal infections, but it requires a simpler and shorter treatment regimen.

What are the advantages of optimized butenafine hydrochloride formulations?

Optimized formulations of butenafine hydrochloride, such as nanostructured lipid carriers, enhance drug delivery, reduce skin irritation, and provide prolonged drug release.

What is the current market size and growth projection for butenafine hydrochloride?

The butenafine hydrochloride market has experienced significant growth and is projected to continue growing robustly until 2031, driven by increasing demand and advancements in formulation technology.

Which regions are expected to see significant growth in the butenafine hydrochloride market?

The market is expected to grow significantly across various geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa.

Sources

  1. Randomised controlled trial of topical butenafine in tinea cruris and tinea corporis. Indian Journal of Dermatology, Venereology and Leprology.
  2. Butenafine Hydrochloride Market Size, Scope And Forecast Report. Market Research Intellect.
  3. Formulation and Optimization of Butenafine-Loaded Topical Nanostructured Lipid Carriers. MDPI.
  4. Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams as Compared to Lotrimin Ultra Cream in Patients With Interdigital Tinea Pedis. ClinicalTrials.gov.
  5. Butenafine Hydrochloride API Market Size, Scope And Forecast Report. Market Research Intellect.

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