CLINICAL TRIALS PROFILE FOR CICLOPIROX

All Clinical Trials for ciclopirox

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00127868 ↗	Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)	Completed	Eastern Virginia Medical School	N/A	2005-03-01	Antifungal shampoos have been used as supplements to oral griseofulvin to help eradicate tinea capitis (also known as ringworm of the scalp) more quickly. While selenium sulfide shampoo has been the gold standard, its strong odor and its drying effect on the scalp discourage many patients from using it. Meanwhile, no other antifungal shampoo has been rigorously evaluated for efficacy. Therefore, while physicians are prescribing griseofulvin accompanied by any of a number of antifungal shampoos for tinea capitis, it is not known which antifungal shampoos (excluding selenium sulfide) actually significantly reduce time to cure, nor which do so the fastest. Scalp ringworm can also re-occur in the same child. To date, no studies have been done to find out whether or not the use of antifungal shampoos can prevent the recurrence of scalp ringworm. In this study, children ages 1-12 years old, who have clinically diagnosed tinea capitis, will all be prescribed oral griseofulvin for 8 weeks. In addition, they will be randomly assigned to use either selenium sulfide shampoo, ketoconazole shampoo, ciclopirox shampoo, or baby shampoo twice a week for 8 weeks. After 8 weeks, griseofulvin will be stopped. All patients will continue using the same assigned shampoo twice weekly for 24 weeks, while continuing to return to clinic every 4 weeks for scalp evaluation.
NCT00127868 ↗	Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)	Completed	Hubbard, Thomas W., M.D.	N/A	2005-03-01	Antifungal shampoos have been used as supplements to oral griseofulvin to help eradicate tinea capitis (also known as ringworm of the scalp) more quickly. While selenium sulfide shampoo has been the gold standard, its strong odor and its drying effect on the scalp discourage many patients from using it. Meanwhile, no other antifungal shampoo has been rigorously evaluated for efficacy. Therefore, while physicians are prescribing griseofulvin accompanied by any of a number of antifungal shampoos for tinea capitis, it is not known which antifungal shampoos (excluding selenium sulfide) actually significantly reduce time to cure, nor which do so the fastest. Scalp ringworm can also re-occur in the same child. To date, no studies have been done to find out whether or not the use of antifungal shampoos can prevent the recurrence of scalp ringworm. In this study, children ages 1-12 years old, who have clinically diagnosed tinea capitis, will all be prescribed oral griseofulvin for 8 weeks. In addition, they will be randomly assigned to use either selenium sulfide shampoo, ketoconazole shampoo, ciclopirox shampoo, or baby shampoo twice a week for 8 weeks. After 8 weeks, griseofulvin will be stopped. All patients will continue using the same assigned shampoo twice weekly for 24 weeks, while continuing to return to clinic every 4 weeks for scalp evaluation.
NCT00127868 ↗	Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)	Completed	Williams, Judith V., M.D.	N/A	2005-03-01	Antifungal shampoos have been used as supplements to oral griseofulvin to help eradicate tinea capitis (also known as ringworm of the scalp) more quickly. While selenium sulfide shampoo has been the gold standard, its strong odor and its drying effect on the scalp discourage many patients from using it. Meanwhile, no other antifungal shampoo has been rigorously evaluated for efficacy. Therefore, while physicians are prescribing griseofulvin accompanied by any of a number of antifungal shampoos for tinea capitis, it is not known which antifungal shampoos (excluding selenium sulfide) actually significantly reduce time to cure, nor which do so the fastest. Scalp ringworm can also re-occur in the same child. To date, no studies have been done to find out whether or not the use of antifungal shampoos can prevent the recurrence of scalp ringworm. In this study, children ages 1-12 years old, who have clinically diagnosed tinea capitis, will all be prescribed oral griseofulvin for 8 weeks. In addition, they will be randomly assigned to use either selenium sulfide shampoo, ketoconazole shampoo, ciclopirox shampoo, or baby shampoo twice a week for 8 weeks. After 8 weeks, griseofulvin will be stopped. All patients will continue using the same assigned shampoo twice weekly for 24 weeks, while continuing to return to clinic every 4 weeks for scalp evaluation.
NCT00127868 ↗	Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)	Completed	Chen, Catherine, M.D.	N/A	2005-03-01	Antifungal shampoos have been used as supplements to oral griseofulvin to help eradicate tinea capitis (also known as ringworm of the scalp) more quickly. While selenium sulfide shampoo has been the gold standard, its strong odor and its drying effect on the scalp discourage many patients from using it. Meanwhile, no other antifungal shampoo has been rigorously evaluated for efficacy. Therefore, while physicians are prescribing griseofulvin accompanied by any of a number of antifungal shampoos for tinea capitis, it is not known which antifungal shampoos (excluding selenium sulfide) actually significantly reduce time to cure, nor which do so the fastest. Scalp ringworm can also re-occur in the same child. To date, no studies have been done to find out whether or not the use of antifungal shampoos can prevent the recurrence of scalp ringworm. In this study, children ages 1-12 years old, who have clinically diagnosed tinea capitis, will all be prescribed oral griseofulvin for 8 weeks. In addition, they will be randomly assigned to use either selenium sulfide shampoo, ketoconazole shampoo, ciclopirox shampoo, or baby shampoo twice a week for 8 weeks. After 8 weeks, griseofulvin will be stopped. All patients will continue using the same assigned shampoo twice weekly for 24 weeks, while continuing to return to clinic every 4 weeks for scalp evaluation.
NCT00802672 ↗	Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis	Completed	Padagis LLC	Phase 3	2003-12-01	The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox Olamine Cream (Test Product) and Ciclopirox Cream 0.77% (Reference Product) in the treatment of subjects with tinea pedis, and to show the superiority of the active treatments over that of the vehicle.
NCT00382330 ↗	Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.	Withdrawn	University of Medicine and Dentistry of New Jersey	N/A	1969-12-31	The purpose of this study is to determine if regular and daily repeated application of the ciclopirox lotion to vulva will make the precancerous lesion(s) shrink or even disappear.

Clinical Trial Conditions for ciclopirox

Condition Name

Condition Name for ciclopirox
Intervention	Trials
Onychomycosis	4
Tinea Pedis	2
Hematologic Malignancy	1
Hodgkin's Disease	1

Condition MeSH

Condition MeSH for ciclopirox
Intervention	Trials
Onychomycosis	5
Tinea	3
Tinea Pedis	2
Foot Dermatoses	1

Clinical Trial Locations for ciclopirox

Trials by Country

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−

Trials by Country for ciclopirox
Location	Trials
Canada	3
United States	3
Germany	1
Brazil	1
France	1

Trials by US State

+

−

Trials by US State for ciclopirox
Location	Trials
California	1
New Jersey	1
Virginia	1

Clinical Trial Progress for ciclopirox

Clinical Trial Phase

Clinical Trial Phase for ciclopirox
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status for ciclopirox
Clinical Trial Phase	Trials
Completed	6
Not yet recruiting	3
Unknown status	2

Clinical Trial Sponsors for ciclopirox

Sponsor Name

Sponsor Name for ciclopirox
Sponsor	Trials
Padagis LLC	2
Perrigo Company	2
Galderma	1

Sponsor Type

Sponsor Type for ciclopirox
Sponsor	Trials
Other	11
Industry	11

Ciclopirox: Clinical Trials, Market Analysis, and Projections

Introduction to Ciclopirox

Ciclopirox is a well-established antifungal agent commonly used to treat various fungal infections such as ringworm, nail fungus, and athlete’s foot. It is available in cream and powder forms. Recently, there has been significant interest in repurposing ciclopirox for other medical conditions, including cancer.

Clinical Trials Update

Fosciclopirox in Acute Myeloid Leukemia (AML)

A notable clinical trial involves fosciclopirox, a parenterally administered prodrug of ciclopirox, which is being developed for the treatment of relapsed/refractory acute myeloid leukemia (R/R AML) and bladder cancer. In a Phase 2a trial conducted by Notable Labs, Ltd. and CicloMed, LLC, the safety and efficacy of fosciclopirox were evaluated in adult patients with R/R AML[1][3].

• Trial Design and Outcomes: The trial aimed to characterize the safety and efficacy of fosciclopirox and to test the Predictive Precision Medicines Platform (PPMP) by Notable Labs. PPMP predicted that all patients enrolled would be non-responsive to fosciclopirox, which was confirmed by the actual patient responses. Although fosciclopirox was well-tolerated, none of the nine evaluable patients achieved a complete response, with only two patients showing stable disease over four months.
• PPMP Validation: The accuracy of PPMP's predictions further validated its potential in drug development. This suggests that using PPMP to selectively enroll patients predicted to respond to treatment could avoid negative clinical outcomes and reduce the risk and cost associated with enrolling non-responsive patients.

Safety and Pharmacokinetics of ATL-001 (Ciclopirox Olamine)

Another clinical trial is focused on assessing the safety, tolerability, and pharmacokinetics of ATL-001 (ciclopirox olamine) in healthy volunteers. This study involves a double-blind, placebo-controlled design where participants receive either the investigational drug or a placebo. The trial includes a 30-day screening period, a 5-day treatment period, and a 30-day follow-up period to assess treatment outcomes[4].

Market Analysis

Current Market Size and Growth

The global ciclopirox market is currently valued at approximately $11.8 million in 2023 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.2% to reach $19.5 million by 2033[2].

• Drivers of Growth: The increasing awareness of personal hygiene, the rising number of fungal infections, and the growing demand for anti-fungal treatments are key drivers of the ciclopirox market. Lifestyle changes, an aging population, and increased use of antibiotics also contribute to market expansion.
• Regional Growth: China is one of the fastest-growing markets for ciclopirox, expected to grow at a CAGR of 5.8% to reach a valuation of $3.6 million by 2033. This growth is driven by an increasing population, rising disposable income, and the development of e-commerce platforms[2].

Market Dynamics

Short-Term Outlook (2023-2026)

The popularity of online sales is expected to drive steady growth in the short term, as more people opt to buy generic medications like ciclopirox directly from online platforms[2].

Medium-Term Outlook (2026-2029)

The overall market demand for ciclopirox is expected to grow due to lifestyle changes, an aging population, and medical conditions such as diabetes. The increased use of antibiotics will also contribute to this growth[2].

Long-Term Outlook (2029-2033)

In the long term, research and development are expected to increase, with dominant players investing more in finding unique solutions and innovations in the ciclopirox market. This will further drive market growth and expansion[2].

Market Projections

Global and Chinese Market Forecast

• Global Market: The global ciclopirox market is forecasted to expand at a CAGR of 5.2% from 2023 to 2033, reaching a valuation of $19.5 million by the end of the period[2].
• Chinese Market: The Chinese market is expected to grow at a CAGR of 5.8%, reaching a total valuation of $3.6 million by 2033. This growth is driven by an increasing population, rising disposable income, and the development of e-commerce platforms[2].

Industry Chain and Economic Impact

• Industry Chain Structure: The ciclopirox market involves a complex industry chain including upstream raw materials, manufacturing, and downstream applications. Understanding this structure is crucial for market analysis and forecasting[5].
• Economic Impact: The global and Chinese macroeconomic environments play significant roles in the ciclopirox market. Factors such as population growth, lifestyle changes, and healthcare awareness will continue to influence market dynamics[5].

Key Takeaways

• Clinical Trials: The use of fosciclopirox in R/R AML trials has highlighted the predictive capabilities of PPMP, which could revolutionize patient enrollment in clinical trials.
• Market Growth: The ciclopirox market is expected to grow steadily, driven by increasing awareness of personal hygiene, lifestyle changes, and an aging population.
• Regional Focus: China is a key market for ciclopirox, with significant growth projected due to demographic and economic factors.
• Research and Development: Continued investment in research and development will drive innovations and further growth in the ciclopirox market.

FAQs

What is the current market size of the ciclopirox market?

The global ciclopirox market is currently valued at approximately $11.8 million in 2023[2].

What is the projected growth rate of the ciclopirox market?

The global ciclopirox market is expected to grow at a CAGR of 5.2% from 2023 to 2033[2].

What are the key drivers of the ciclopirox market growth?

Key drivers include increasing awareness of personal hygiene, rising fungal infections, lifestyle changes, an aging population, and the growing use of antibiotics[2].

How does the Predictive Precision Medicines Platform (PPMP) impact clinical trials?

PPMP has shown accuracy in predicting patient responses to treatment, suggesting its potential to selectively enroll responsive patients and avoid negative clinical outcomes[1][3].

What is the significance of the Chinese market in the ciclopirox market growth?

China is expected to grow at a CAGR of 5.8%, driven by an increasing population, rising disposable income, and the development of e-commerce platforms[2].

Sources

1. Notable Labs, Ltd. and CicloMed, LLC. "Notable Reports Predictive Precision Medicine Platform (PPMP) Accurately Predicted Fosciclopirox Trial Outcome." Biospace, 18 Dec. 2023.
2. Fact.MR. "Ciclopirox Market Size, Demand & Growth Report by 2033." Fact.MR, 2023.
3. GlobeNewswire. "Notable Reports Predictive Precision Medicine Platform (PPMP) Accurately Predicted Fosciclopirox Trial Outcome." GlobeNewswire, 18 Dec. 2023.
4. Veeva Systems. "Study to Assess the Safety and Pharmacokinetics of ATL-001 (Ciclopirox Olamine) in Healthy Volunteer." ClinicalTrials.gov, 24 Jul. 2024.
5. Prof Research. "Ciclopirox Market Size, Share, Trend and Forecast to 2029." Prof Research, 2024.