CLINICAL TRIALS PROFILE FOR MICONAZOLE 3

All Clinical Trials for Miconazole 3

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00498680 ↗	Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i	Unknown status	Rambam Health Care Campus	Phase 4	2007-03-01	A prospective, randomized, 3-arm parallel trial on 45 males with ED that were never exposed to PDE5i therapy (naïve patients) will be enrolled.In each group, every patient will receive three treatment regimes (Viagra®50mg & Levitra®10mg, Viagra®100mg, Levitra®20mg), in different sequences of administration in such a manner that eventually each patient will receive all regimes in a double- blinded fasion.Safety will be evaluated at pre- screening by measuring hourly vital signs (blood pressure, heart rate)for 4 consecutive hours after taking half-dose combination. Any decrease in blood pressure of 20 mmhg below baseline will exclude the subject from the study. Effcacy will be evaluated by questionnaires (IIEF, Quality of erection questionnaire, grade of erection scale, Sear, QVS and Sexual Encounter Profiles for each sexual event). Non-parametric statistical analysis of the collected data Comparing the 3 groups will be performed.
NCT00390780 ↗	Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients	Completed	Onxeo	Phase 3	2006-07-01	The purpose of this study is to evaluate the clinical cure of miconazole Lauriad 50 mg (1x50mg) Bioadhesive buccal tablets compared with clotrimazole troches (5x10mg) after 14 days of treatment (at the test of cure visit, at Day 17-19).
NCT00128323 ↗	A Comparison of Gentian Violet (GV) Mouth Washes, Nystatin, and Ketoconazole Tabs in Treating Oropharyngeal Candidiasis	Completed	British Society for Antimicrobial Chemotherapy	Phase 3	2002-11-01	In resource constrained societies and where HIV is a problem, oral thrush causes significant morbidity. In adults, ketoconazole is used and sometimes oral nystatin. Both drugs are relatively expensive compared to GV solution and ketoconazole has significant side effects especially in association with some of the treatments for HIV related problems. In children, either GV solutions or nystatin are used, GV is a fraction of the cost of nystatin. GV at 1% solution discolours the mouth (blue) and in the older child and adult would mark them out as having HIV infections. A much more dilute solution of GV has proved equally effective in vitro and would not carry the same cosmetic problem. In this study of children, the investigators have compared the 3 solutions, 1% GV, 0.00165% GV and nystatin oral drops - all masked so that they look the same - to see if GV is more effective than nystatin, and to see if the weaker solution of GV is as effective as the stronger solution.
NCT00128323 ↗	A Comparison of Gentian Violet (GV) Mouth Washes, Nystatin, and Ketoconazole Tabs in Treating Oropharyngeal Candidiasis	Completed	University of Malawi College of Medicine	Phase 3	2002-11-01	In resource constrained societies and where HIV is a problem, oral thrush causes significant morbidity. In adults, ketoconazole is used and sometimes oral nystatin. Both drugs are relatively expensive compared to GV solution and ketoconazole has significant side effects especially in association with some of the treatments for HIV related problems. In children, either GV solutions or nystatin are used, GV is a fraction of the cost of nystatin. GV at 1% solution discolours the mouth (blue) and in the older child and adult would mark them out as having HIV infections. A much more dilute solution of GV has proved equally effective in vitro and would not carry the same cosmetic problem. In this study of children, the investigators have compared the 3 solutions, 1% GV, 0.00165% GV and nystatin oral drops - all masked so that they look the same - to see if GV is more effective than nystatin, and to see if the weaker solution of GV is as effective as the stronger solution.
NCT00004575 ↗	Effects of Miconazole on Blood Flow	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 1	2000-02-01	This study will investigate the effect of the drug miconazole on blood vessel dilation. Miconazole stops production of EDHF, a substance that causes arteries to dilate. EDHF is produced by the cells that line blood vessels. Normal volunteers between the ages of 21 to 60 may participate in this study. Candidates will be screened for eligibility with a medical history, physical examination, electrocardiogram and routine laboratory tests. Those enrolled will be injected with miconazole to study its effects on blood vessels. Study participants will take three aspirin tablets. After administration of a local anesthetic, small tubes will be inserted through a needle into the artery and vein of the forearm. These will be used to measure blood pressure and to draw blood samples during the study. Forearm blood flow will be measured using pressure cuffs placed on the wrist and upper arm, and a strain gauge (a rubber band device) placed around the forearm. When the cuffs are inflated, blood will flow into the arm, stretching the strain gauge, and the flow measurement will be recorded. Small doses of four drugs-bradykinin, sodium nitroprusside, miconazole, and LNMMA-will be given through the arterial catheter. Bradykinin stimulates the release of EDHF and can lower blood pressure. Sodium nitroprusside causes blood vessels to dilate and is used to treat high blood pressure and heart failure. Miconazole is commonly prescribed to treat various infections, including vaginal yeast infections, jock itch and athlete's foot. In much higher doses, it is used to treat fungal infections that have spread to the lungs, brain, kidneys, or bladder. LNMMA inhibits production of nitric oxide, another substance produced by the lining cells of blood vessels. Blood flow will be measured throughout the study, which will last approximately 3 hours.

Clinical Trial Conditions for Miconazole 3

Condition Name

Condition Name for Miconazole 3
Intervention	Trials
Otomycosis	3
Bacterial Vaginosis	3
Oral Lichen Planus	3
Healthy	2

Condition MeSH

Condition MeSH for Miconazole 3
Intervention	Trials
Candidiasis	6
Candidiasis, Oral	3
Vaginal Diseases	3
Otomycosis	3

Clinical Trial Locations for Miconazole 3

Trials by Country

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−

Trials by Country for Miconazole 3
Location	Trials
United States	35
China	7
Brazil	5
Canada	4
Kenya	2

Trials by US State

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−

Trials by US State for Miconazole 3
Location	Trials
Florida	5
California	4
Alabama	3
Texas	3
Michigan	2

Clinical Trial Progress for Miconazole 3

Clinical Trial Phase

Clinical Trial Phase for Miconazole 3
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	8
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Miconazole 3
Clinical Trial Phase	Trials
Completed	21
Unknown status	3
Not yet recruiting	3

Clinical Trial Sponsors for Miconazole 3

Sponsor Name

Sponsor Name for Miconazole 3
Sponsor	Trials
Hill Dermaceuticals, Inc.	3
Embil Pharmaceutical Co. Ltd	2
National Institute of Allergy and Infectious Diseases (NIAID)	2

Sponsor Type

Sponsor Type for Miconazole 3
Sponsor	Trials
Other	27
Industry	15
NIH	3

Miconazole: Clinical Trials, Market Analysis, and Projections

Introduction to Miconazole

Miconazole is a widely used antifungal medication, effective against a variety of fungal infections, including vaginal candidiasis (VVC), skin infections, and oral candidiasis. Here, we will delve into recent clinical trials, market analysis, and future projections for miconazole.

Clinical Trials Update

Efficacy and Safety of Miconazole vs. Alternative Treatments

A recent clinical trial compared the efficacy and safety of miconazole with a probiotic treatment, LF5, for the treatment of VVC. The study found that both treatments achieved high rates of microbiological eradication of Candida spp. within a three-day treatment period, with 96% for LF5 and 94% for miconazole. However, LF5 had a significantly lower incidence of local adverse reactions (4% vs. 12% for miconazole)[1].

Treatment of Oral Candidiasis

Another study evaluated the therapeutic effects of topical miconazole and miconazole-loaded chitosan nanoparticles in treating oral candidiasis in diabetic patients. Both treatments showed comparable effectiveness in controlling symptoms and reducing Candida colonization, with no adverse reactions reported. The miconazole-loaded chitosan nanoparticles demonstrated a significant reduction in Candida albicans colonies over the 28-day treatment period[4].

Market Analysis

Global Market Size and Growth

The global miconazole market has been experiencing significant growth. As of 2023, the market size was valued at millions of dollars, with a projected compound annual growth rate (CAGR) from 2024 to 2031. The market is segmented by type, application, and region, with the suppositories segment and skin infections segment expected to see significant growth[2].

Regional Analysis

The market is analyzed across major regions including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region provides revenue share, current trends, and future projections. The report includes detailed country-level analysis to help understand the market dynamics better[2].

Key Applications and Segments

Miconazole is used in various applications, including vaginal candidiasis, skin infections, and oral candidiasis. The suppositories segment accounted for a noticeable share of the global market in 2023 and is expected to continue growing. The skin infections segment is also anticipated to expand significantly during the forecast period[2].

Market Projections

Forecast Period 2024-2031

The global miconazole market is forecasted to grow from 2024 to 2031, driven by increasing demand for antifungal treatments and advancements in delivery systems such as miconazole-loaded chitosan nanoparticles. The market size is expected to increase, with a CAGR that reflects the growing need for effective antifungal medications[2].

Competitive Landscape

Key companies such as Johnson & Johnson (Ortho-McNeil Pharmaceutical) and Endo are focusing on strengthening their product portfolios and expanding their business in the global market. These companies are investing in research and development to improve the efficacy and safety of miconazole formulations[2].

Technological Trends and Innovations

Nanotechnology in Drug Delivery

The use of miconazole-loaded chitosan nanoparticles is a significant technological trend. This formulation enhances the delivery and efficacy of miconazole, reducing adverse reactions and improving patient compliance. Such innovations are expected to drive market growth by offering more effective and safer treatment options[4].

Market Drivers and Restraints

Drivers

• Increasing prevalence of fungal infections
• Advancements in drug delivery systems
• Growing demand for antifungal treatments
• Expansion of healthcare infrastructure in emerging markets

Restraints

• Side effects associated with traditional miconazole formulations
• Competition from alternative antifungal treatments
• Regulatory challenges and patent expirations

Consumer Behavior and ESG Analysis

Consumer behavior is shifting towards safer and more effective treatments, driving the demand for formulations with lower adverse reaction rates. Environmental, Social, and Governance (ESG) factors are also becoming increasingly important, with companies focusing on sustainable manufacturing practices and ethical business models[2].

Conclusion

Miconazole remains a vital antifungal medication with a strong market presence. Recent clinical trials highlight its efficacy and the potential benefits of newer formulations like miconazole-loaded chitosan nanoparticles. The market is expected to grow significantly, driven by technological innovations, increasing demand, and strategic investments by key players.

Key Takeaways

• Miconazole is effective in treating various fungal infections with high microbiological eradication rates.
• Newer formulations like LF5 and miconazole-loaded chitosan nanoparticles offer reduced adverse reactions and improved patient compliance.
• The global miconazole market is projected to grow significantly from 2024 to 2031.
• Technological trends such as nanotechnology are enhancing drug delivery and efficacy.
• Market drivers include increasing demand and advancements in healthcare, while restraints include side effects and regulatory challenges.

FAQs

What are the common applications of miconazole?

Miconazole is commonly used to treat vaginal candidiasis, skin infections, and oral candidiasis.

How does miconazole compare to other antifungal treatments in terms of efficacy?

Miconazole has been shown to be as effective as other treatments like LF5 in clinical trials, with high rates of microbiological eradication of Candida spp.[1].

What are the advantages of miconazole-loaded chitosan nanoparticles?

Miconazole-loaded chitosan nanoparticles offer improved delivery, reduced adverse reactions, and enhanced clinical improvement in treating oral candidiasis[4].

Which regions are expected to drive the growth of the miconazole market?

North America, Europe, and Asia Pacific are expected to be key regions driving the growth of the miconazole market due to their large healthcare markets and increasing demand for antifungal treatments[2].

What are the major challenges facing the miconazole market?

Major challenges include side effects associated with traditional formulations, competition from alternative treatments, and regulatory challenges[2].

Sources

1. Frontiers in Microbiology: "Comparative Analysis with Topical Miconazole in a Single-Blind..."
2. Cognitive Market Research: "Miconazole Market Report 2024 (Global Edition)"
3. Biospace: "U.S. Clinical Trials Market Size Industry Analysis Report, 2033"
4. PubMed: "The anti-fungal effect of miconazole and miconazole-loaded chitosan nanoparticles..."
5. Cognitive Market Research: "Global Miconazole Nitrate Market Report 2024 Edition"