CLINICAL TRIALS PROFILE FOR GRISEOFULVIN

All Clinical Trials for Griseofulvin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00117754 ↗	Terbinafine Compared to Griseofulvin in Children With Tinea Capitis	Completed	Novartis	Phase 3	2004-07-01	Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules and pruritus are the primary clinical signs which can be associated with tinea capitis. The infection is caused by a relatively small group of dermatophytes in the genera Trichophyton and Microsporum. Terbinafine hydrochloride is a synthetic allylamine derivative antifungal agent. This study will evaluate the efficacy and safety of terbinafine in children with tinea capitis.
NCT00117767 ↗	Terbinafine Compared to Griseofulvin in Children With Tinea Capitis	Completed	Novartis Pharmaceuticals	Phase 3	2004-06-01	Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules and pruritus are the primary clinical signs which can be associated with tinea capitis. The infection is caused by a relatively small group of dermatophytes in the genera Trichophyton and Microsporum. Terbinafine hydrochloride is a synthetic allylamine derivative antifungal agent. This study will evaluate the efficacy and safety of terbinafine in children with tinea capitis.
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.

Clinical Trial Conditions for Griseofulvin

Condition Name

Condition Name for Griseofulvin
Intervention	Trials
Healthy	3
Tinea Capitis	3
Dyslipidemias	1
Erythema Dyschromicum Perstans	1

Condition MeSH

Condition MeSH for Griseofulvin
Intervention	Trials
Tinea	4
Tinea Capitis	3
Lichen Planus	2
Malnutrition	1

Clinical Trial Locations for Griseofulvin

Trials by Country

Trials by Country for Griseofulvin
Location	Trials
United States	5
Canada	2
Mexico	1
Germany	1
Brazil	1

Trials by US State

Trials by US State for Griseofulvin
Location	Trials
Virginia	2
New Jersey	2
Michigan	1

Clinical Trial Progress for Griseofulvin

Clinical Trial Phase

Clinical Trial Phase for Griseofulvin
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	3
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Griseofulvin
Clinical Trial Phase	Trials
Completed	8
Unknown status	3
Withdrawn	1

Clinical Trial Sponsors for Griseofulvin

Sponsor Name

Sponsor Name for Griseofulvin
Sponsor	Trials
Actavis Inc.	2
Novartis	2
Postgraduate Institute of Medical Education and Research	1

Sponsor Type

Sponsor Type for Griseofulvin
Sponsor	Trials
Other	11
Industry	9

Griseofulvin: A Comprehensive Review of Clinical Trials, Market Analysis, and Projections

Introduction to Griseofulvin

Griseofulvin is a well-established antifungal medication that has been widely used for the treatment of various fungal infections, particularly those affecting the skin, hair, and nails. Its mechanism of action involves targeting tubulin, a protein essential for cell division, thereby inhibiting the growth and replication of fungal cells[1].

Clinical Trials and Efficacy

Historical Clinical Trials

Griseofulvin has undergone extensive clinical trials since its introduction. In one notable study, 175 patients with various types of ringworm infections were treated with griseofulvin. The results showed that oral administration of the drug led to significant improvements, with some patients experiencing complete clearing of skin lesions. Topical administration was also found to be effective, especially for conditions like tinea pedis, where oral administration yielded erratic results[4].

Current Clinical Landscape

As of the latest data, griseofulvin is part of a broader category of tubulin inhibitors, with 483 such drugs worldwide, involving 536 organizations, and covering 303 indications. These drugs are undergoing 12,054 clinical trials, indicating a robust and ongoing research interest in this therapeutic area[1].

Market Analysis

Global Market Size and Forecast

The global market for griseofulvin was estimated to be worth several million dollars in 2023 and is forecasted to grow at a compound annual growth rate (CAGR) through 2030. The market is segmented by region, with North America, Europe, and the Asia-Pacific region being key markets. The Asia-Pacific region is expected to show significant growth due to favorable government policies, the growing pharmaceutical industry, and the cost-effectiveness of clinical trials in this region[2][5].

Regional Market Performance

• North America: The North American market for griseofulvin was valued at several million dollars in 2023 and is projected to grow at a CAGR through 2030.
• Europe: The European market also shows a similar trend, with a forecasted growth rate through the same period.
• Asia-Pacific: This region is expected to register the highest CAGR due to its burgeoning pharmaceutical industry and favorable regulatory environment[5].

Key Players

The global griseofulvin market is dominated by several key players, including GlaxoSmithKline, Inga Pharmaceuticals, Dr. Reddy's Laboratories, CFL Pharmaceuticals Limited, and others. These companies hold a significant share of the market revenue and are driving innovation and growth in the sector[5].

Market Trends and Drivers

Increasing R&D Investments

The global griseofulvin market is driven by increasing investments in pharmaceutical research and development (R&D). This trend is part of a broader shift in the pharmaceutical industry, where companies are outsourcing R&D functions to Contract Research Organizations (CROs) to enhance efficiency and reduce costs[3].

Growing Demand for Antifungal Treatments

The demand for antifungal treatments, including griseofulvin, is on the rise due to the increasing prevalence of fungal infections. This demand is further exacerbated by the growing resistance to existing antifungal drugs, making new and effective treatments like griseofulvin more critical[1].

Regulatory Environment

Favorable regulatory environments, particularly in the Asia-Pacific region, are supporting the growth of the griseofulvin market. Improved regulatory procedures and the implementation of policies that encourage clinical trials and drug development are key factors driving this growth[3].

Challenges and Restraints

Side Effects and Safety Concerns

While griseofulvin is generally well-tolerated, it can cause side effects such as gastrointestinal disturbances, headaches, and in rare cases, more serious adverse reactions. These safety concerns can impact patient compliance and overall market growth[4].

Competition from New Therapies

The antifungal market is competitive, with new therapies and drugs being developed. This competition can pose a challenge to the market share of griseofulvin, especially if newer drugs offer better efficacy or safety profiles[1].

Future Projections

Market Growth

The global griseofulvin market is expected to continue growing, driven by increasing demand for antifungal treatments and ongoing R&D investments. The market is forecasted to reach a significant size by 2030, with the Asia-Pacific region playing a pivotal role in this growth[5].

Technological Advancements

Advancements in drug delivery systems and the development of new formulations could enhance the efficacy and safety of griseofulvin, further solidifying its position in the market. Topical formulations, in particular, are expected to see significant improvements, given their importance in treating skin infections[4].

Key Takeaways

• Established Efficacy: Griseofulvin has a long history of efficacy in treating fungal infections, particularly those affecting the skin and musculoskeletal system.
• Global Market Growth: The global market for griseofulvin is expected to grow, driven by increasing R&D investments and a favorable regulatory environment.
• Regional Variations: The Asia-Pacific region is anticipated to show the highest growth rate due to its growing pharmaceutical industry and cost-effective clinical trials.
• Challenges and Opportunities: While side effects and competition from new therapies pose challenges, advancements in drug delivery systems and formulations offer opportunities for growth.

FAQs

What is the primary mechanism of action of griseofulvin?

Griseofulvin works by targeting tubulin, a protein essential for cell division, thereby inhibiting the growth and replication of fungal cells[1].

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

The Asia-Pacific region is expected to drive the growth of the griseofulvin market due to its growing pharmaceutical industry, favorable regulatory environment, and cost-effective clinical trials[5].

What are the common indications for griseofulvin?

Griseofulvin is commonly used to treat various fungal infections, including dermatomycoses, onychomycosis, tinea, tinea barbae, tinea capitis, and tinea pedis[1].

Who are the key players in the global griseofulvin market?

Key players include GlaxoSmithKline, Inga Pharmaceuticals, Dr. Reddy's Laboratories, CFL Pharmaceuticals Limited, and others[5].

What are the potential challenges facing the griseofulvin market?

Challenges include side effects and safety concerns, as well as competition from new and potentially more effective antifungal therapies[4].

Sources

1. Patsnap Synapse: Griseofulvin: Detailed Review of its Transformative R&D Success.
2. Cognitivemarketresearch.com: Global Griseofulvin Market Report 2024 Edition.
3. Marketsandmarkets.com: Clinical Trials Market Size, Share, Trends and Revenue Forecast.
4. Jamanetwork.com: CURRENT STATUS OF GRISEOFULVIN: REPORT ON ONE.
5. Qyresearch.com: Griseofulvin - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030.