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Last Updated: March 24, 2025

CLINICAL TRIALS PROFILE FOR MICONAZOLE 7


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All Clinical Trials for Miconazole 7

Trial ID Title Status Sponsor Phase Start Date Summary
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.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Miconazole 7

Condition Name

Condition Name for Miconazole 7
Intervention Trials
Bacterial Vaginosis 3
Oral Lichen Planus 3
Otomycosis 3
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Condition MeSH

Condition MeSH for Miconazole 7
Intervention Trials
Candidiasis 6
Otomycosis 3
Lichen Planus, Oral 3
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Clinical Trial Locations for Miconazole 7

Trials by Country

Trials by Country for Miconazole 7
Location Trials
United States 35
China 7
Brazil 5
Canada 4
Egypt 2
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Trials by US State

Trials by US State for Miconazole 7
Location Trials
Florida 5
California 4
Texas 3
Alabama 3
Kentucky 2
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Clinical Trial Progress for Miconazole 7

Clinical Trial Phase

Clinical Trial Phase for Miconazole 7
Clinical Trial Phase Trials
Phase 4 9
Phase 3 8
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Miconazole 7
Clinical Trial Phase Trials
Completed 21
Unknown status 3
Not yet recruiting 3
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Clinical Trial Sponsors for Miconazole 7

Sponsor Name

Sponsor Name for Miconazole 7
Sponsor Trials
Hill Dermaceuticals, Inc. 3
University of Sao Paulo 2
Embil Pharmaceutical Co. Ltd 2
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Sponsor Type

Sponsor Type for Miconazole 7
Sponsor Trials
Other 27
Industry 15
NIH 3
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Miconazole 7: Clinical Trials, Market Analysis, and Projections

Introduction to Miconazole 7

Miconazole 7, a formulation of the antifungal drug miconazole nitrate, is widely used for the treatment of various fungal infections, particularly vulvovaginal candidiasis (VVC) and other dermatological conditions. Here, we will delve into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Vulvovaginal Candidiasis (VVC) Treatment

Several clinical trials have evaluated the efficacy and safety of miconazole 7 in treating VVC. A notable study compared a single-dose miconazole nitrate vaginal ovule with the traditional seven-day regimen of Monistat 7 (miconazole nitrate 2% vaginal cream)[1].

  • Efficacy: The study found that the single-dose ovule had cure rates of 71.7% and 61.5% in two separate trials, while Monistat 7 had cure rates of 70.1% and 61.1%. The ovule provided significantly faster complete symptom relief, with a median time of 4 days compared to 5 days for Monistat 7.
  • Safety and Patient Preference: Both treatments were found to be safe, with consistent safety results between groups. Patients preferred the single-dose ovule over prior therapies.

Another study compared butoconazole nitrate 2% bioadhesive, sustained-release cream with a seven-day schedule of miconazole nitrate vaginal cream 2% (miconazole 7)[3].

  • Symptom Relief: Butoconazole 1-BSR showed rapid relief of symptoms, with severe symptoms receding faster than after the first dose of miconazole 7. However, overall efficacy parameters were not significantly different between the two treatments.

Oral Candidiasis in Diabetic Patients

A recent clinical trial evaluated the effectiveness of miconazole and miconazole-loaded chitosan nanoparticles in treating oral candidiasis in diabetic patients[4].

  • Efficacy: Both miconazole and miconazole-loaded chitosan nanoparticles were effective in controlling symptoms and reducing Candida colonization. There was no significant difference in antifungal efficacy between the two treatments, but the nanoparticle formulation showed significant clinical improvement and reduction in Candida albicans colonies.

Market Analysis

Global Market Size and Growth

The global miconazole market has been growing steadily. According to the Miconazole Market Report 2024, the market size is expected to increase from 2024 to 2031, driven by various factors such as increasing prevalence of fungal infections and advancements in antifungal therapies[2].

  • Market Segmentation: The market is segmented by type, application, and region. Key regions include North America, Europe, Asia Pacific, Middle East & Africa, and Latin America.
  • CAGR and Forecast: The compound annual growth rate (CAGR) for the miconazole market is projected to be significant from 2024 to 2031, indicating a robust growth trajectory.

Regional Analysis

The miconazole market is analyzed across major regions, each contributing significantly to the global market size.

  • North America and Europe: These regions are expected to maintain their dominance due to high awareness and advanced healthcare infrastructure.
  • Asia Pacific: This region is anticipated to show rapid growth due to increasing healthcare expenditure and a large patient population.

Key Applications

Miconazole is used in various applications, including:

  • Vulvovaginal Candidiasis: A primary application, where miconazole 7 is a standard treatment.
  • Dermatological Conditions: Miconazole is used to treat skin fungal infections such as athlete's foot and ringworm.
  • Oral Candidiasis: As seen in the clinical trial, miconazole is effective in treating oral thrush, especially in diabetic patients.

Market Projections

Future Growth Drivers

Several factors are expected to drive the growth of the miconazole market:

  • Increasing Prevalence of Fungal Infections: Rising incidence of fungal infections due to factors like antibiotic use, immunosuppression, and diabetes will drive demand for antifungal drugs.
  • Advancements in Formulations: New formulations such as single-dose ovules and nanoparticle-loaded miconazole are expected to enhance patient compliance and efficacy.
  • Expanding Healthcare Infrastructure: Improvements in healthcare infrastructure, especially in emerging markets, will increase access to antifungal treatments.

Challenges and Opportunities

  • Competition from Alternative Treatments: The market faces competition from other antifungal drugs and newer therapies, which could impact market share.
  • Regulatory Approvals: Continuous regulatory approvals for new formulations and indications will be crucial for market growth.
  • Research and Development: Ongoing R&D in antifungal therapies, including the use of nanoparticles, presents opportunities for innovation and market expansion.

Key Takeaways

  • Clinical Efficacy: Miconazole 7 has been shown to be effective in treating VVC and oral candidiasis, with new formulations offering faster symptom relief.
  • Market Growth: The global miconazole market is projected to grow significantly from 2024 to 2031, driven by increasing prevalence of fungal infections and advancements in antifungal therapies.
  • Regional Dynamics: North America and Europe are expected to remain key markets, while the Asia Pacific region is anticipated to show rapid growth.
  • Future Prospects: The market will be driven by new formulations, expanding healthcare infrastructure, and ongoing R&D in antifungal therapies.

FAQs

What is the primary use of Miconazole 7?

Miconazole 7 is primarily used for the treatment of vulvovaginal candidiasis (VVC) and other dermatological fungal infections.

How effective is Miconazole 7 in treating VVC?

Miconazole 7 has been shown to be highly effective in treating VVC, with cure rates comparable to other antifungal treatments and faster symptom relief in some formulations.

What are the key drivers of the miconazole market growth?

The key drivers include increasing prevalence of fungal infections, advancements in antifungal therapies, and expanding healthcare infrastructure.

Are there any new formulations of miconazole being developed?

Yes, new formulations such as single-dose ovules and miconazole-loaded chitosan nanoparticles are being developed to enhance efficacy and patient compliance.

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

North America and Europe are expected to remain dominant, while the Asia Pacific region is anticipated to show rapid growth due to increasing healthcare expenditure and a large patient population.

Sources

  1. Pubmed: Single-dose miconazole nitrate vaginal ovule in the treatment of vulvovaginal candidiasis.
  2. Cognitive Market Research: Miconazole Market Report 2024 (Global Edition).
  3. Pubmed: Butoconazole nitrate 2% for vulvovaginal candidiasis. New, single-dose bioadhesive, sustained-release cream.
  4. Pubmed: The anti-fungal effect of miconazole and miconazole-loaded chitosan nanoparticles in the treatment of oral candidiasis in diabetic patients.
  5. News Channel Nebraska: Compound Miconazole Nitrate Cream Market 2024-2031.

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