CLINICAL TRIALS PROFILE FOR GYNE-LOTRIMIN 3

All Clinical Trials for GYNE-LOTRIMIN 3

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 3

Condition Name

Condition Name for GYNE-LOTRIMIN 3
Intervention	Trials
Tinea Pedis	2
Dermatitis, Photoallergic	1
Interdigital Tinea Pedis	1

Condition MeSH

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

Clinical Trial Locations for GYNE-LOTRIMIN 3

Trials by Country

+

−

Trials by Country for GYNE-LOTRIMIN 3
Location	Trials
United States	10
Belize	1

Trials by US State

+

−

Trials by US State for GYNE-LOTRIMIN 3
Location	Trials
Tennessee	1
South Carolina	1
Ohio	1
North Carolina	1
Michigan	1

Clinical Trial Progress for GYNE-LOTRIMIN 3

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for GYNE-LOTRIMIN 3

Sponsor Name

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

Sponsor Type

Sponsor Type for GYNE-LOTRIMIN 3
Sponsor	Trials
Industry	4

Gyne-Lotrimin 3: Clinical Trials, Market Analysis, and Projections

Introduction to Gyne-Lotrimin 3

Gyne-Lotrimin 3 is an antifungal medication, specifically a vaginal cream containing 2% clotrimazole, used to treat vaginal candida (yeast) infections. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Vaginal Candidiasis Treatment

Clinical trials have demonstrated the efficacy of Gyne-Lotrimin 3 in treating vaginal candidiasis. The treatment typically involves applying one applicatorful of the 2% vaginal cream intravaginally at bedtime for 3 days in non-pregnant patients. For pregnant patients, the treatment duration can be 7 to 14 days with a 1% vaginal cream[1][4].

Safety and Adverse Reactions

Clinical trials have also highlighted the safety profile of Gyne-Lotrimin 3. Common adverse reactions include vaginal irritation, skin irritation, abdominal pain, nausea, and vaginal pain. More severe reactions, though rare, can include elevated hepatic enzymes and urticaria[1].

Special Considerations

Patients are advised not to use tampons, douches, or spermicides during treatment and to abstain from sexual activity. The cream can damage condoms, diaphragms, and cervical caps, leading to contraceptive failure[1].

Market Analysis

Market Size and Growth

The clotrimazole market, which includes Gyne-Lotrimin 3, is projected to grow significantly. By 2030, the global clotrimazole market is estimated to reach $4.2 billion, growing at a CAGR of 6.2% during the forecast period 2024-2030[2].

Market Segments

The market is segmented by type, application, and sales channel. The cream segment is expected to hold the largest market share due to its widespread use in treating various fungal infections, including vaginal candidiasis[2].

Geographic Dominance

North America currently dominates the clotrimazole market, with online pharmacies emerging as the fastest-growing sales channel. This trend is driven by the increasing prevalence of diseases such as vaginitis, athlete’s foot, and other fungal infections[2].

Key Market 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 antifungal medication sector[2].

Market Projections

Increasing Demand

The increasing prevalence of fungal infections, such as vaginitis and athlete’s foot, is expected to propel the growth of the clotrimazole market. Additionally, the growing application of clotrimazole in other forms of disease treatment will further drive market expansion[2].

Competitive Landscape

The market is competitive, with several substitutes available. However, the efficacy and safety profile of Gyne-Lotrimin 3, along with its established brand presence, position it strongly in the market. The availability of online pharmacies and other sales channels is also expected to boost sales[2].

Impact of External Factors

COVID-19 and Global Events

The COVID-19 pandemic and other global events, such as the Ukraine crisis, have had mixed impacts on the pharmaceutical industry. While there have been disruptions in supply chains, the increased focus on healthcare has also driven demand for antifungal medications like Gyne-Lotrimin 3[2].

Key Takeaways

• Efficacy and Safety: Gyne-Lotrimin 3 is effective in treating vaginal candidiasis with a manageable side effect profile.
• Market Growth: The clotrimazole market is projected to grow at a CAGR of 6.2% to reach $4.2 billion by 2030.
• Geographic Dominance: North America leads the market, with online pharmacies being a key sales channel.
• Competitive Landscape: Major pharmaceutical companies drive the market, with Gyne-Lotrimin 3 maintaining a strong position.
• Increasing Demand: Growing prevalence of fungal infections and expanding applications of clotrimazole will drive market growth.

FAQs

What is Gyne-Lotrimin 3 used for?

Gyne-Lotrimin 3 is used to treat vaginal candida (yeast) infections.

How is Gyne-Lotrimin 3 administered?

It is administered intravaginally using an applicator, typically at bedtime for 3 to 14 days depending on the patient's condition and pregnancy status.

What are the common side effects of Gyne-Lotrimin 3?

Common side effects include vaginal irritation, skin irritation, abdominal pain, nausea, and vaginal pain.

Can Gyne-Lotrimin 3 be used during pregnancy?

Yes, but the treatment duration and dosage may vary. For pregnant patients, the treatment can be 7 to 14 days with a 1% vaginal cream[1].

How is the market for Gyne-Lotrimin 3 projected to grow?

The clotrimazole market, including Gyne-Lotrimin 3, is projected to grow at a CAGR of 6.2% to reach $4.2 billion by 2030[2].

Sources

1. PDR.Net: Gyne-Lotrimin - Drug Summary.
2. IndustryARC: Clotrimazole Market - Forecast(2017-2025) Research Report.
3. Prime Therapeutics: Quarterly Drug Pipeline: July 2024.
4. RxList: Gyne-Lotrimin (Clotrimazole Vaginal Cream).
5. FDA: Gyne Lotrimin 3 Vaginal Cream (Clotrimazole) NDA# 20-574.