CLINICAL TRIALS PROFILE FOR GENTIAN VIOLET

All Clinical Trials for Gentian Violet

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00707174 ↗	Combination Therapy With Imiquimod Cream 5% and Tazarotene Cream 0.1% for the Treatment of Lentigo Maligna	Completed	University of Utah	N/A	2005-03-01	This study is designed as a randomized, prospective study to test the efficacy of imiquimod plus tazarotene in the treatment of LM. Eligible and consented patients will be randomized to one of two treatment groups: 1) topical imiquimod group, or 2) topical imiquimod combined with topical tazarotene group. All patients will undergo a staged surgical excision with rush permanent sections to confirm negative histologic margins. This will be followed by a surgical repair of the defect and long-term follow-up of five years to rule out recurrences. Both groups will have a polygonal excision using 2mm margins per stage.

Clinical Trial Conditions for Gentian Violet

Condition Name

Condition Name for Gentian Violet
Intervention	Trials
Otomycosis	2
Hidradenitis Suppurativa	1
HIV-1 Infection	1

Condition MeSH

Condition MeSH for Gentian Violet
Intervention	Trials
Otomycosis	2
Candidiasis	2
Hidradenitis	1

Clinical Trial Locations for Gentian Violet

Trials by Country

Trials by Country for Gentian Violet
Location	Trials
United States	2
Malawi	2
Botswana	1
Uganda	1
Thailand	1

Trials by US State

Trials by US State for Gentian Violet
Location	Trials
North Carolina	1
Utah	1

Clinical Trial Progress for Gentian Violet

Clinical Trial Phase

Clinical Trial Phase for Gentian Violet
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	1
N/A	3

Clinical Trial Status

Clinical Trial Status for Gentian Violet
Clinical Trial Phase	Trials
Completed	4
Not yet recruiting	2

Clinical Trial Sponsors for Gentian Violet

Sponsor Name

Sponsor Name for Gentian Violet
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	1
AIDS Clinical Trials Group	1
Khon Kaen Hospital	1

Sponsor Type

Sponsor Type for Gentian Violet
Sponsor	Trials
Other	7
NIH	1

Gentian Violet: Clinical Trials, Market Analysis, and Projections

Introduction

Gentian violet, a synthetic dye with antiseptic and antifungal properties, has been used in various medical and veterinary applications. However, its use has been marred by concerns over its safety and carcinogenic potential. Here, we delve into the current state of clinical trials, market analysis, and future projections for gentian violet.

Clinical Trials and Safety Concerns

Carcinogenicity Studies

Extensive animal studies have shown that gentian violet is a genotoxic carcinogen. In studies conducted on rats and mice, gentian violet induced tumors at multiple sites, including the liver, thyroid gland, testis, and epididymis. These findings have led regulatory bodies to classify gentian violet as a potential carcinogen[1][2].

Human Health Implications

Despite the absence of reported cancer cases in humans associated with topical use, the potential for oral exposure to cause cancer is a significant concern. Health Canada has identified adverse events, including localized skin reactions and discoloration, but no cancer cases have been reported. However, the manufacturer of Gentiane Violet Liquid Topical voluntarily discontinued the sale of the product in Canada due to the potential cancer risk[2].

Ongoing Clinical Trials

A current survey study is investigating the use of gentian violet in treating hidradenitis suppurativa (HS), a chronic skin condition. This study aims to assess the efficacy of gentian violet in improving wound healing and quality of life for HS patients. The study relies on qualitative survey responses and quantitative changes in skin appearance[4].

Market Analysis

Current Market Status

Gentian violet is no longer approved for use in veterinary medicine or as a food additive in many countries. In the United States, the FDA has not approved gentian violet for veterinary use, and its use as a food additive or new animal drug requires prior FDA approval, which has not been granted[5].

Human Health Products

In human health, gentian violet is used in non-prescription drug products and medical devices such as foam wound dressings. However, due to safety concerns, the sale of gentian violet-containing products has been discontinued in some regions, such as Canada[2].

Market Projections

Regulatory Environment

The regulatory environment is a significant factor in the market projection for gentian violet. Given the carcinogenic potential and genotoxic effects, it is unlikely that gentian violet will be approved for new uses or reinstated in markets where it has been discontinued. Regulatory bodies such as Health Canada and the FDA are likely to maintain strict oversight, limiting market growth[2][5].

Alternative Treatments

The market for antiseptic and antifungal treatments is competitive, with many safer alternatives available. The development and approval of new, safer treatments will further reduce the demand for gentian violet, making it less viable in the market.

Global Trends

While the global market for antiseptic and antifungal treatments is growing, driven by increasing prevalence of infections and advancements in healthcare, gentian violet is not expected to benefit from these trends due to its safety concerns. Other regions, such as Asia Pacific, are seeing growth in the healthcare sector, but this growth is driven by safer and more effective treatments[3].

Key Takeaways

• Carcinogenic Potential: Gentian violet has been shown to be a genotoxic carcinogen in animal studies.
• Regulatory Actions: The sale of gentian violet-containing products has been discontinued in some regions due to safety concerns.
• Clinical Trials: Ongoing studies are limited, and the focus is on assessing its efficacy in specific conditions like hidradenitis suppurativa.
• Market Projections: The market for gentian violet is expected to decline due to regulatory restrictions and the availability of safer alternatives.
• Global Trends: The healthcare market is growing, but gentian violet is unlikely to benefit from these trends.

FAQs

Q1: What are the primary concerns associated with the use of gentian violet?

The primary concerns include its carcinogenic potential, genotoxic effects, and the induction of tumors in animal studies.

Q2: Are there any ongoing clinical trials for gentian violet?

Yes, there is an ongoing survey study investigating the use of gentian violet in treating hidradenitis suppurativa.

Q3: Why has the sale of gentian violet-containing products been discontinued in some regions?

The sale has been discontinued due to the potential cancer risk and other safety concerns identified through animal studies and regulatory assessments.

Q4: What is the current regulatory status of gentian violet?

Gentian violet is not approved for veterinary use or as a food additive in many countries. Its use in human health products is also under strict regulatory oversight.

Q5: How does the market for gentian violet compare to other antiseptic and antifungal treatments?

The market for gentian violet is expected to decline due to safety concerns, while the market for other antiseptic and antifungal treatments is growing driven by safer and more effective alternatives.

Sources

1. OEHHA: Evidence on the Carcinogenicity of Gentian Violet - OEHHA
2. Health Canada: Summary Safety Review - Gentian violet-containing human health products
3. Biospace: Oncology Clinical Trials Market Size Expected to Reach USD 22.11 BN by 2033
4. Veeva: Gentian Violet Treatment for Hidradenitis Suppurativa
5. GAO: FDA's Regulation Of Gentian Violet Appears Reasonable