CLINICAL TRIALS PROFILE FOR CLOTRIMAZOLE

505(b)(2) Clinical Trials for CLOTRIMAZOLE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT03115073 ↗	ProF-001_Phase IIa	Completed	ProFem GmbH	Phase 2/Phase 3	2017-04-04	This is a multi-center, randomized, prospective, active-controlled, double-blind, dose-escalation study comparing dose response of clinical efficacy, safety, local tolerability of three different doses of ProF-001/Candiplus® (Candiplus® 0.2%, Candiplus® with 0.3%, Candiplus® with 0.4%) to 1% clotrimazole vaginal cream. Patients with acute episode of vulvovaginal candidiasis (VVC) will be randomized to receive a daily dose of either 5 ml (intravaginal) of Candiplus® at three different doses for the first 3 days and 2.5 ml for the remaining 3 days or 5 ml (intravaginal) application of 1% clotrimazole cream over the first 3 days and 2.5 ml for the remaining 3 days according to the following scheme (with each application 2 cm of cream will be applied to the vulvar region): Cohort 1: Candiplus® 0.2% versus clotrimazole mono Cohort 2: Candiplus® 0.3% versus clotrimazole mono Cohort 3: Candiplus® 0.4% versus clotrimazole mono Randomization into the cohorts will occur consecutively from the lowest dose to the highest dose, i.e. patients will be randomized first in cohort 1 and finally in cohort 3. The proposed study is - after a pilot study to assess critical pharmacokinetic data - the second study within a clinical trial program with the objective to develop a new combination therapy for the treatment of vulvovaginal candidiasis. The new combination consists of two registered drug substances.

All Clinical Trials for CLOTRIMAZOLE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004404 ↗	Study of Clotrimazole and Hydroxyurea in Patients With Sickle Cell Syndromes	Completed	Boston Children's Hospital	N/A	1997-04-01	OBJECTIVES: Determine the effectiveness of the combined use of clotrimazole and hydroxyurea on a specific panel of red cell characteristics in patients with sickle cell syndromes.
NCT00004404 ↗	Study of Clotrimazole and Hydroxyurea in Patients With Sickle Cell Syndromes	Completed	Boston Children’s Hospital	N/A	1997-04-01	OBJECTIVES: Determine the effectiveness of the combined use of clotrimazole and hydroxyurea on a specific panel of red cell characteristics in patients with sickle cell syndromes.
NCT00000676 ↗	Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)	Completed	Pfizer	Phase 3	1969-12-31	To study the effectiveness, safety, and tolerance of fluconazole versus clotrimazole troches (lozenges) as prophylaxis (preventive treatment) against fungal infections in patients enrolled in ACTG 081 (a study of prophylaxis against pneumocystosis, toxoplasmosis, and serious bacterial infection). Primarily, to compare the rates of invasive infections by C. neoformans, endemic mycoses, and Candida. To compare the mortality rates due to fungal infections between two antifungal prophylactic treatments. Secondarily, to assess the effect of prophylaxis on the incidence of severe fungal infections, defined as invasive infections and esophageal candidiasis and less severe mucocutaneous infection. Serious fungal infections are significant complicating and life-threatening occurrences in patients with advanced HIV infection. Oropharyngeal candidiasis is found in almost all such patients, and causes pain, difficulty in swallowing, and loss of appetite. Similarly, esophageal candidiasis causes illness in the population. Cryptococcosis, endemic mycoses, and coccidioidomycosis also cause significant illness and death in AIDS patients. Once established, fungal infections in AIDS patients generally require continuous suppressive therapy because attempts at curing these infections are usually unsuccessful. Fluconazole has a number of characteristics that would make it a logical candidate to examine as a prophylactic agent in patients with advanced HIV infection. Animal studies have shown it to be prophylactic in models of candidiasis, cryptococcosis, histoplasmosis, and coccidioidomycosis. Initial experience in patients with active cryptococcal meningitis appears favorable, and studies of oropharyngeal candidiasis show it to be effective.
NCT00000676 ↗	Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To study the effectiveness, safety, and tolerance of fluconazole versus clotrimazole troches (lozenges) as prophylaxis (preventive treatment) against fungal infections in patients enrolled in ACTG 081 (a study of prophylaxis against pneumocystosis, toxoplasmosis, and serious bacterial infection). Primarily, to compare the rates of invasive infections by C. neoformans, endemic mycoses, and Candida. To compare the mortality rates due to fungal infections between two antifungal prophylactic treatments. Secondarily, to assess the effect of prophylaxis on the incidence of severe fungal infections, defined as invasive infections and esophageal candidiasis and less severe mucocutaneous infection. Serious fungal infections are significant complicating and life-threatening occurrences in patients with advanced HIV infection. Oropharyngeal candidiasis is found in almost all such patients, and causes pain, difficulty in swallowing, and loss of appetite. Similarly, esophageal candidiasis causes illness in the population. Cryptococcosis, endemic mycoses, and coccidioidomycosis also cause significant illness and death in AIDS patients. Once established, fungal infections in AIDS patients generally require continuous suppressive therapy because attempts at curing these infections are usually unsuccessful. Fluconazole has a number of characteristics that would make it a logical candidate to examine as a prophylactic agent in patients with advanced HIV infection. Animal studies have shown it to be prophylactic in models of candidiasis, cryptococcosis, histoplasmosis, and coccidioidomycosis. Initial experience in patients with active cryptococcal meningitis appears favorable, and studies of oropharyngeal candidiasis show it to be effective.
NCT00000991 ↗	A Study of Three Drugs Plus Zidovudine in the Prevention of Infections in HIV-Infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To evaluate and compare 3 anti-pneumocystis regimens plus zidovudine (AZT) in persons with HIV infection and T4 cell count less than 200 cells/mm3. All persons completing at least 8 weeks of therapy on 081 will be offered the opportunity to participate in the nested study (ACTG 981) of systemic antifungal therapy (fluconazole) versus local therapy (Clotrimazole) for the prevention of serious fungal disease. Persons with HIV disease who are receiving AZT are at risk for PCP, toxoplasmosis, bacterial pneumonia, and other serious infections. It is therefore important to find drugs that can be given along with AZT to control these infections. Aerosolized pentamidine (PEN) has been shown to be useful in preventing PCP and is expected to lower the 2-year risk of PCP. Both sulfamethoxazole/trimethoprim (SMX/TMP) and dapsone probably also provide effective preventive treatment against PCP, and both may be useful in preventing toxoplasmosis and extrapulmonary pneumocystosis.
NCT00002282 ↗	A Comparison of the Safety and Effectiveness of Fluconazole or Clotrimazole in the Treatment of Fungal Infections of the Mouth and Throat in Patients With AIDS	Completed	Pfizer	N/A	1969-12-31	To compare the efficacy, safety, and tolerance of fluconazole single daily capsule for 14 days versus clotrimazole troche 5 x daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS.

Clinical Trial Conditions for CLOTRIMAZOLE

Condition Name

Condition Name for CLOTRIMAZOLE
Intervention	Trials
Vulvovaginal Candidiasis	4
HIV Infections	4
Candidiasis	3
Otomycosis	3

Condition MeSH

Condition MeSH for CLOTRIMAZOLE
Intervention	Trials
Candidiasis	16
Candidiasis, Vulvovaginal	9
Infections	6
Infection	6

Clinical Trial Locations for CLOTRIMAZOLE

Trials by Country

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Trials by Country for CLOTRIMAZOLE
Location	Trials
United States	61
Brazil	7
Germany	6
Canada	4
India	4

Trials by US State

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−

Trials by US State for CLOTRIMAZOLE
Location	Trials
Massachusetts	5
Pennsylvania	5
New York	5
Maryland	4
California	4

Clinical Trial Progress for CLOTRIMAZOLE

Clinical Trial Phase

Clinical Trial Phase for CLOTRIMAZOLE
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	12
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for CLOTRIMAZOLE
Clinical Trial Phase	Trials
Completed	22
Unknown status	5
Withdrawn	3

Clinical Trial Sponsors for CLOTRIMAZOLE

Sponsor Name

Sponsor Name for CLOTRIMAZOLE
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	3
Pfizer	2
Peking University Shenzhen Hospital	2

Sponsor Type

Sponsor Type for CLOTRIMAZOLE
Sponsor	Trials
Other	26
Industry	19
NIH	4

Clinical Trials, Market Analysis, and Projections for Clotrimazole

Introduction to Clotrimazole

Clotrimazole is an antifungal medication widely used to treat various fungal infections, including vaginitis, athlete's foot, and other dermatological conditions. Here, we will delve into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Stability Studies

Clinical trials and stability studies are crucial for understanding the efficacy and safety of clotrimazole formulations. A notable study focused on the stability and retention of clotrimazole gels and creams in vitro and in vivo.

• Stability and Retention: A study evaluated the stability and retention of 1% clotrimazole gels and creams in the frontal sinus of dogs. The results showed that these formulations remained chemically stable and were retained within the sinus for at least 2 weeks, with minimal absorption and no adverse effects[4].

Market Analysis

The clotrimazole market is experiencing significant growth driven by several key factors.

Market Size and Growth

• The global clotrimazole market is projected to grow substantially, though estimates vary:
  • One report suggests the market will reach $4.2 billion by 2030, growing at a CAGR of 6.2% during the forecast period 2024-2030[1].
  • Another report indicates a more modest growth, with the market expected to reach $0.01 billion by 2032 at a CAGR of 1.2%[3].

Geographical Distribution

• North America dominates the clotrimazole market, with significant contributions from the U.S., Canada, and Mexico[1].

Segmentation

• By Type: The market is segmented into suppositories, tablets, creams, and others. Creams are the largest segment, holding over 40% of the market share[2].
• By Application: Key applications include vaginitis, otomycosis, paronychia, tinea of feet and hands, and tinea corporis[2][3].

Sales Channels

• Online pharmacies are emerging as the fastest-growing segment, indicating a shift towards digital healthcare solutions[1].

Key Market Players

Several companies are prominent in the clotrimazole market:

• Bayer AG, Novartis AG, Amoli Organics Pvt. Ltd., Guangzhou Hanpu Pharmaceutical Co., Ltd., and Ciron Group are among the leading players[1][2].

Drivers and Restraints

Drivers

• The increasing prevalence of fungal infections such as vaginitis, athlete’s foot, and others is a significant driver[1][3].
• Rising healthcare awareness and the growing application of clotrimazole in various disease treatments also contribute to market growth[1][5].

Restraints

• The sizable number of side effects associated with clotrimazole and the availability of substitutes in the market are notable restraints[1].

Regional Analysis

The clotrimazole market is analyzed across various regions:

• North America: Dominates the market due to high healthcare spending and advanced medical infrastructure[1].
• Europe: Significant market share, with countries like Germany, France, and the UK contributing substantially[1].
• Asia-Pacific: Growing rapidly due to increasing healthcare awareness and improving economic conditions[1].

Technological and Regulatory Landscape

• The market is influenced by technological advancements in drug formulation and delivery systems. For instance, the development of stable and effective gel and cream formulations enhances the drug's retention and efficacy[4].
• Regulatory frameworks and compliance with standards such as those set by the USP (United States Pharmacopeia) are crucial for ensuring the quality and safety of clotrimazole products[4].

Future Projections

Growth Opportunities

• The expanding use of clotrimazole in treating various fungal infections and its potential applications in other disease treatments offer significant growth opportunities[1][5].

Challenges

• The market faces challenges from side effects and the availability of substitutes, which could impact growth. However, ongoing research and development are expected to mitigate these challenges[1].

Key Takeaways

• The clotrimazole market is projected to grow significantly, driven by the increasing prevalence of fungal infections and the expanding application of the drug.
• Cream formulations are the largest segment, and online pharmacies are the fastest-growing sales channel.
• North America dominates the market, but the Asia-Pacific region is expected to grow rapidly.
• Key players are focusing on strengthening their product portfolios and expanding their business globally.

Frequently Asked Questions (FAQs)

1. What is the projected market size of clotrimazole by 2030?

The global clotrimazole market is estimated to reach $4.2 billion by 2030, growing at a CAGR of 6.2% during the forecast period 2024-2030[1].

2. Which segment holds the largest market share in the clotrimazole market?

The cream segment holds the largest market share, with over 40% of the market[2].

3. What are the main drivers of the clotrimazole market?

The increasing prevalence of fungal infections and the growing application of clotrimazole in other disease treatments are key drivers[1][3].

4. Who are the leading players in the clotrimazole market?

Leading players include Bayer AG, Novartis AG, Amoli Organics Pvt. Ltd., Guangzhou Hanpu Pharmaceutical Co., Ltd., and Ciron Group[1][2].

5. What are the potential restraints for the clotrimazole market?

The sizable number of side effects and the availability of substitutes in the market are significant restraints[1].

Cited Sources:

1. IndustryARC, Clotrimazole Market - Forecast(2017-2025) Research Report.
2. Valuates Reports, Clotrimazole Market, Report Size, Worth, Revenue, Growth, Industry ....
3. Business Research Insights, Clotrimazole Market Size, Share - Analysis To 2032.
4. AVMA Journals, Assessment of clotrimazole gels for in vitro stability and in vivo ....
5. Cognitive Market Research, Clotrimazole Market Report 2024 (Global Edition).