CLINICAL TRIALS PROFILE FOR GYNE-LOTRIMIN

All Clinical Trials for GYNE-LOTRIMIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04532164 ↗	Study to Find Out if Cream V61-044 Used to Treat Fungal Infections Causes an Allergic Skin Reaction to Sunlight in Healthy Participants	Completed	Bayer	Phase 3	2013-06-10	Allergic skin reaction can be produced by the combination of a chemical product applied to the skin and ultraviolet (UV) radiation (a type of invisible light that comes from the sun and other light sources and can hurt your skin and eyes) received by the person. The researchers in this study wanted to find out if cream V61-044 might cause an allergic skin reaction to sunlight when applied to the skin in healthy participants. Cream V61-044 (brand name: LOTRIMIN ULTRA) is an approved drug used to treat infections caused by fungi (small growing organisms such as mold, mildew, yeast or mushrooms). Participants joining this study underwent two study phases: in Induction phase, participants received the test cream and UV radiation twice a week for 3 weeks; after 10 days of rest, in Challenge phase participants received the test cream and UV radiation once again. In both phases, the test cream was applied to two test areas on the upper back of the participants and to one of the test area UV radiation was applied. Evaluation on the skin rash was conducted two days after each UV radiation.
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).

Clinical Trial Conditions for GYNE-LOTRIMIN

Condition Name

Condition Name for GYNE-LOTRIMIN
Intervention	Trials
Tinea Pedis	2
Dermatitis, Photoallergic	1
Interdigital Tinea Pedis	1

Condition MeSH

Condition MeSH for GYNE-LOTRIMIN
Intervention	Trials
Tinea	3
Tinea Pedis	3
Dermatitis, Photoallergic	1
Dermatitis	1

Clinical Trial Locations for GYNE-LOTRIMIN

Trials by Country

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Trials by Country for GYNE-LOTRIMIN
Location	Trials
United States	10
Belize	1

Trials by US State

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−

Trials by US State for GYNE-LOTRIMIN
Location	Trials
New Jersey	1
Texas	1
Tennessee	1
South Carolina	1
Ohio	1

Clinical Trial Progress for GYNE-LOTRIMIN

Clinical Trial Phase

Clinical Trial Phase for GYNE-LOTRIMIN
Clinical Trial Phase	Trials
Phase 3	1
Phase 1	3

Clinical Trial Status

Clinical Trial Status for GYNE-LOTRIMIN
Clinical Trial Phase	Trials
Completed	3
Terminated	1

Clinical Trial Sponsors for GYNE-LOTRIMIN

Sponsor Name

Sponsor Name for GYNE-LOTRIMIN
Sponsor	Trials
Taro Pharmaceuticals USA	3
Bayer	1

Sponsor Type

Sponsor Type for GYNE-LOTRIMIN
Sponsor	Trials
Industry	4

GYNE-LOTRIMIN: Clinical Trials, Market Analysis, and Projections

Introduction to GYNE-LOTRIMIN

GYNE-LOTRIMIN, containing the active ingredient clotrimazole, is an antifungal medication specifically designed to treat vaginal candida (yeast) infections. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Usage

Efficacy and Safety

Clinical trials have demonstrated the efficacy and safety of clotrimazole in treating vaginal yeast infections. The drug is very poorly absorbed after intravaginal administration, which minimizes systemic side effects. Studies have shown that vaginal use of clotrimazole during the second and third trimesters of pregnancy has not resulted in any adverse effects, although there are no adequate and well-controlled studies during the first trimester[1].

Dosage and Administration

The typical dosage for GYNE-LOTRIMIN involves inserting one applicatorful of the 1% or 2% vaginal cream into the vagina at bedtime for 7 to 14 days or 3 days, respectively. External application can also be used to relieve vulvar itching associated with yeast infections[1][4].

Adverse Reactions

Common adverse reactions include vaginal irritation, skin irritation, abdominal pain, nausea, and pruritus. More severe reactions, though less common, can include elevated hepatic enzymes and vaginal pain[1].

Market Analysis

Current Market Size and Growth

The global vaginal antifungals market, in which GYNE-LOTRIMIN is a significant player, was valued at US$1 billion in 2021. Clotrimazole held a substantial market share of 33% in this segment. The market is projected to expand at a CAGR of 3.6% to reach US$1.41 billion by 2032[5].

Regional Market Share

North America and Europe dominate the market, with North America holding a 36.1% market share and Europe accounting for 28.3% in 2021. Germany, in particular, accounted for a 5.3% share of the global vaginal antifungals market in 2021[5].

Key Market Drivers

The growth of the vaginal antifungals market is driven by several factors, including:

• Rising cases of vaginal yeast infections
• Growing awareness about personal hygiene and availability of treatment options
• Increased access to healthcare
• Limited data on the prevalence of vaginal fungal infections, providing opportunities for further research and development[5].

Market Projections

Future Growth

The clotrimazole market, specifically, is expected to grow significantly. The global clotrimazole market is projected to reach US$4.2 billion by 2030, growing at a CAGR of 6.2% during the forecast period 2024-2030. This growth is attributed to the increasing prevalence of diseases such as vaginitis, athlete’s foot, and other fungal infections[2].

Market Segments

The market is segmented by type, application, and sales channel. The cream segment is expected to hold the largest market share, and online pharmacies are emerging as the fastest-growing sales channel[2].

Key Players

Major players in the clotrimazole market include Bayer AG, Novartis AG, Amoli Organics Pvt. Ltd., and Guangzhou Hanpu Pharmaceutical Co., Ltd. These companies are driving innovation and expansion in the market[2].

Impact of Regulatory and Technological Advancements

Predictive Drug Safety and Efficacy Models

Initiatives like the Advanced Research Projects Agency for Health (ARPA-H)’s CATALYST program aim to develop predictive drug safety and efficacy models. These models could enhance the preclinical safety and efficacy assessments of drugs like clotrimazole, potentially reducing the failure rate of drug candidates and improving patient safety[3].

Key Takeaways

• Efficacy and Safety: GYNE-LOTRIMIN has been proven effective and safe in clinical trials for treating vaginal yeast infections.
• Market Growth: The global vaginal antifungals market, led by clotrimazole, is expected to grow at a CAGR of 3.6% to reach US$1.41 billion by 2032.
• Regional Dominance: North America and Europe are the leading regions in the market, with Germany being a significant contributor.
• Future Projections: The clotrimazole market is projected to reach US$4.2 billion by 2030, driven by increasing disease prevalence and growing application in other disease treatments.
• Technological Advancements: Predictive drug safety and efficacy models are expected to improve the development and regulatory approval process for antifungal drugs.

FAQs

What is GYNE-LOTRIMIN used for?

GYNE-LOTRIMIN is used to treat vaginal candida (yeast) infections, relieving symptoms such as itching and burning[4].

What is the typical dosage for GYNE-LOTRIMIN?

The typical dosage involves inserting one applicatorful of the 1% or 2% vaginal cream into the vagina at bedtime for 7 to 14 days or 3 days, respectively[1][4].

Can GYNE-LOTRIMIN be used during pregnancy?

GYNE-LOTRIMIN can be used during the second and third trimesters of pregnancy, but there are no adequate and well-controlled studies during the first trimester[1].

What are the common side effects of GYNE-LOTRIMIN?

Common side effects include vaginal irritation, skin irritation, abdominal pain, nausea, and pruritus[1].

How is the market for vaginal antifungals expected to grow?

The global vaginal antifungals market is expected to grow at a CAGR of 3.6% to reach US$1.41 billion by 2032[5].

Sources

1. PDR.Net: Gyne-Lotrimin - Drug Summary.
2. IndustryARC: Clotrimazole Market - Forecast(2017-2025) Research Report.
3. ARPA-H: ARPA-H launches program to develop predictive drug safety and efficacy modeling platforms.
4. RxList: Gyne-Lotrimin (Clotrimazole Vaginal Cream).
5. Persistence Market Research: Market Study on Vaginal Antifungals.