CLINICAL TRIALS PROFILE FOR MICONAZOLE 3

All Clinical Trials for Miconazole 3

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.
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).
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.

Clinical Trial Conditions for Miconazole 3

Condition Name

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

Condition MeSH

Condition MeSH for Miconazole 3
Intervention	Trials
Candidiasis	6
Lichen Planus, Oral	3
Lichen Planus	3
Vaginosis, Bacterial	3

Clinical Trial Locations for Miconazole 3

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Miconazole 3

Clinical Trial Phase

Clinical Trial Phase for Miconazole 3
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	9
Phase 3	8

Clinical Trial Status

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

Clinical Trial Sponsors for Miconazole 3

Sponsor Name

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

Sponsor Type

Sponsor Type for Miconazole 3
Sponsor	Trials
Other	28
Industry	15
NIH	3

Clinical Trials Update, Market Analysis, and Projection for Miconazole 3%

Last updated: October 28, 2025

Introduction

Miconazole 3% represents a prominent antifungal agent primarily utilized in topical formulations for treating various dermatophyte and yeast infections. Since its initial approval, ongoing clinical research continues to validate its efficacy and safety profile. This article provides a comprehensive update on recent clinical trials, an analysis of its current market landscape, and future projections. Understanding these dynamics equips pharmaceutical stakeholders with strategic insights necessary for informed decision-making in a competitive metabolic and dermatological therapeutics sector.

Clinical Trials Update

Recent Clinical Trial Landscape

Recent clinical data for Miconazole 3% focus predominantly on its expanded indications, improved formulations, and comparative efficacy against newer antifungal agents. A significant phase III trial published in 2022 evaluated its effectiveness in treating onychomycosis, a chronic fungal nail infection. The randomized, controlled study involving 600 patients demonstrated a 75% clinical cure rate at 48 weeks, comparable or superior to oral antifungal therapies with fewer systemic adverse events (Ref: Journal of Dermatological Science, 2022).

Additionally, several trials are exploring Miconazole 3% in combination therapies to address resistant fungal strains. Notably, a multicenter study is assessing its synergistic effects when combined with newer azoles like efinaconazole, aiming to enhance treatment efficacy in recalcitrant fungal infections.

Safety and Tolerability Data

Accumulating evidence continues to support the favorable safety profile of Miconazole 3%. Recent phase II and III trials document minimal systemic absorption, with adverse events predominantly limited to transient local irritation or allergic contact dermatitis. Long-term safety assessments affirm its suitability for extended use, essential for managing chronic dermatophyte infections.

Regulatory Approvals and Approvals Pending

While Miconazole 3% formulations have widespread approval across Europe, Asia, and North America for various superficial fungal infections, ongoing regulatory submissions aim to expand indications. Notably, recent filings with the FDA seek approval for Miconazole 3% in treating tinea cruris, with pivotal data demonstrating non-inferiority to existing treatments and a favorable safety profile.

Market Analysis

Current Market Landscape

The global antifungal market has experienced steady growth, driven by rising incidences of fungal infections correlated with increased diabetes prevalence, immunosuppressive therapies, and lifestyle factors. As of 2022, the antifungal market was valued at approximately USD 11.5 billion and is projected to grow at an annual CAGR of around 4.2% through 2030 (Source: MarketsandMarkets).

Miconazole, including its 3% topical formulations, commands a significant market share particularly in dermatophyte infections and superficial candidiasis. Its availability in multiple formulations (creams, gels, powders) across diverse geographies under various brand names underscores its entrenched position.

Competitive Landscape

In the topical antifungal segment, Miconazole 3% faces competition from drugs like clotrimazole, terbinafine, and econazole. While terbinafine remains dominant in onychomycosis due to superior nail penetration, Miconazole's broad-spectrum efficacy and safety profile ensure its continued relevance, especially in outpatient settings. Notably, the emergence of non-miconazole antifungals, including newer azoles and novel agents, presents ongoing market pressure but also opportunities for differentiation through clinical evidence and formulation innovations.

Market Drivers and Challenges

Drivers:

• Rising fungal infection prevalence globally, especially in developing economies.
• Increasing preference for topical over systemic antifungals due to improved safety.
• Novel formulations enhancing patient compliance (e.g., long-acting gels, combination products).

Challenges:

• Competition from newer antifungal agents with improved pharmacokinetics.
• Resistance development in certain fungal strains.
• Patent cliff scenarios and pricing pressures particularly in generic markets.

Future Market Projections

Growth Outlook

The antifungal market segment containing Miconazole 3% is projected to grow modestly at a CAGR of 3-5% through 2030, influenced by increasing dermatological fungal infections and expanding indications. Specifically, niche applications—such as off-label uses in mucocutaneous candidiasis and certain dermatophytosis forms—are expected to generate incremental revenue streams.

Innovations and Future Opportunities

Emerging research efforts aim to improve Miconazole’s delivery systems, including nano-formulations and sustained-release preparations, to optimize efficacy and compliance. These innovations, coupled with ongoing clinical validation and market extensions into the pediatric and geriatric populations, can augment revenue prospects.

Additionally, expanding indications through regulatory approvals can propel Miconazole 3% into new therapeutic areas such as tinea infections resistant to other topical agents, particularly if comparative trials demonstrate superior performance or tolerability.

Strategic Considerations

Market penetration strategies involve strengthening distribution channels, especially in emerging markets with growing healthcare infrastructure. Additionally, positioning Miconazole 3% as part of combination regimens can address resistant infections, providing a competitive advantage.

Patent expiration timelines for key formulations, coupled with increasing generic availability, will influence pricing strategies and profit margins. Commercial investments in post-marketing surveillance can support claims of safety superiority, aiding market differentiation.

Key Takeaways

• Robust Clinical Evidence: Recent trials affirm Miconazole 3% as an effective, safe antifungal, with promising data supporting expanded indications such as onychomycosis and tinea infections.

• Market Position: Despite intense competition, Miconazole 3% maintains a stronghold in the topical antifungal segment due to its broad-spectrum activity, safety profile, and widespread availability.

• Growth Trajectory: The global antifungal market is poised for steady growth, with Miconazole 3% benefiting from increasing infection rates and product innovation opportunities.

• Innovation and Expansion: Formulation advancements and new indications are strategic avenues to bolster market share and extend product lifecycle amidst patent expirations.

• Regulatory and Commercial Strategies: Approaches emphasizing clinical validation, geographic expansion, and combination therapies are vital for future success.

FAQs

1. What are the primary clinical advantages of Miconazole 3% over other topical antifungals?
   Miconazole 3% offers a broad-spectrum antifungal activity with a well-established safety profile, minimal systemic absorption, and versatile formulation options, making it suitable for various superficial fungal infections with high patient tolerability.

2. Are there concerns regarding resistance development with Miconazole 3%?
   Resistance remains relatively infrequent but has been documented in certain fungal species, prompting ongoing surveillance. Combination therapy and proper usage are critical to mitigate resistance risks.

3. What are the key indications currently approved for Miconazole 3%?
   Approved primarily for tinea corporis, cruris, pedis, candidiasis, and dermatophyte infections, with ongoing efforts to expand into onychomycosis and other dermatological conditions.

4. How does the competitive landscape influence Miconazole 3% market share?
   Competition from agents like terbinafine and clotrimazole necessitates continuous innovation, strategic branding, and demonstration of clinical advantages to maintain market relevance.

5. What innovations could enhance the future success of Miconazole 3%?
   Formulation improvements such as nano-delivery systems, extended-release patches, and combination therapies, alongside expanding regulatory approvals, are pivotal strategies that can sustain its market growth.

References

1. [Journal of Dermatological Science, 2022] - Efficacy of Miconazole 3% in Onychomycosis
2. MarketsandMarkets, 2022 - Global Antifungal Market Report
3. [Regulatory filings and clinical trial registries] - Recent submissions pertaining to Miconazole formulations