CLINICAL TRIALS PROFILE FOR ROSE BENGAL SODIUM I-131

All Clinical Trials for ROSE BENGAL SODIUM I-131

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04686461 ↗	Effect of Thymoquinone Extracted From Nigella Sativa in the Treatment of Arsenical Keratosis	Recruiting	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	N/A	2019-10-20	Prepare an ointment from Nigella sativa seeds extract and apply it over palmer arsenical keratosis patient for 12 weeks. After than the effect of the ointment will be observed by measuring the keratotic nodular size before and after the intervention.
NCT00797030 ↗	Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus	Unknown status	Universidade Federal do Rio de Janeiro	Phase 4	2006-10-01	This study evaluates the use of topical cyclosporine 0.05% and sodium carboxymethylcellulose 0.5% for the treatment of dry eye disease in patients infected with the human immunodeficiency virus. Twenty HIV-positive-patients were selected from the Department of Infectious Diseases of the Federal University of Rio de Janeiro Hospital. Dry eye diagnosis was based on a dry eye questionnaire (Ocular Surface Disease Index - OSDI®), Schirmer I Test, break up time and 1% rose bengal staining of the ocular surface. The patients were divided into two groups with ten patients. Group I received sodium carboxymethylcellulose 0.5% drops and group II received sodium carboxymethylcellulose 0,5% drops and topical cyclosporine 0.05% for six months.
NCT01240382 ↗	Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye	Completed	Santen Pharmaceutical Co., Ltd.	Phase 3	1969-12-31	To investigate that the efficacy of 3% DE-089 ophthalmic solution (one drop at a time, 6 times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate ophthalmic solution (0.1% HA) (one drop at a time, 6 times daily, 4 weeks topical administration), is at least non-inferior in the change in fluorescein staining score, and is superior in the change in Rose bengal score, in a multicenter, double-masked, parallel-group comparison study. Safety profile will likewise be compared.

Clinical Trial Conditions for ROSE BENGAL SODIUM I-131

Condition Name

Condition Name for ROSE BENGAL SODIUM I-131
Intervention	Trials
Dry Eye	1
Dry Eye Syndromes	1
HIV Seropositivity	1
Keratotic Nodular Size	1

Condition MeSH

Condition MeSH for ROSE BENGAL SODIUM I-131
Intervention	Trials
Keratoconjunctivitis Sicca	2
Dry Eye Syndromes	2
Immunologic Deficiency Syndromes	1
HIV Seropositivity	1

Clinical Trial Locations for ROSE BENGAL SODIUM I-131

Trials by Country

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Trials by Country for ROSE BENGAL SODIUM I-131
Location	Trials
Japan	1
Brazil	1
Bangladesh	1

Clinical Trial Progress for ROSE BENGAL SODIUM I-131

Clinical Trial Phase

Clinical Trial Phase for ROSE BENGAL SODIUM I-131
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
N/A	1

Clinical Trial Status

Clinical Trial Status for ROSE BENGAL SODIUM I-131
Clinical Trial Phase	Trials
Unknown status	1
Completed	1
Recruiting	1

Clinical Trial Sponsors for ROSE BENGAL SODIUM I-131

Sponsor Name

Sponsor Name for ROSE BENGAL SODIUM I-131
Sponsor	Trials
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	1
Universidade Federal do Rio de Janeiro	1
Santen Pharmaceutical Co., Ltd.	1

Sponsor Type

Sponsor Type for ROSE BENGAL SODIUM I-131
Sponsor	Trials
Other	2
Industry	1

Rose Bengal Sodium I-131: Clinical Trials, Market Analysis, and Projections

Introduction

Rose Bengal, a synthetic dye, has been extensively used in various medical applications, including ophthalmology and oncology. When combined with radioactive iodine (I-131), it forms Rose Bengal sodium I-131, a compound with potential therapeutic uses. Here, we delve into the current state of clinical trials, market analysis, and future projections for this drug.

Historical Use and Current Applications

Rose Bengal has a long history of use in medical diagnostics, particularly in ophthalmology for staining corneal and conjunctival epithelial defects, and in liver function tests[1][2][5].

Clinical Trials

Antibacterial and Antimicrobial Applications

Recent studies have explored the antibacterial and antimicrobial properties of Rose Bengal, particularly in the context of photodynamic therapy. For instance, Rose Bengal photodynamic antimicrobial therapy (RB-PDAT) has shown promise in treating infectious keratitis, including fungal and Acanthamoeba keratitis. Clinical trials, such as the REAGIR study, are ongoing to evaluate the efficacy of RB-PDAT using green light activation[2].

Oncological Applications

While the primary focus of Rose Bengal sodium I-131 has been on diagnostic and antimicrobial uses, its derivatives have been studied for cancer treatment. For example, the radioactive component (I-131) is known for its use in targeted radiotherapy. However, specific clinical trials focusing on Rose Bengal sodium I-131 for cancer treatment are limited, and most research is centered around its photodynamic properties rather than its radioactive component.

Mechanism of Action

Rose Bengal, when activated by light at a specific wavelength (520 nm, green light), generates reactive oxygen species (ROS) that are highly effective against microbial cells. This mechanism is crucial in photodynamic therapy, where the ROS attack essential cell components, leading to the death of microorganisms[2].

Market Analysis

Current Market Landscape

The market for antimicrobial and antibacterial therapies is growing due to the increasing prevalence of multidrug-resistant infections. Rose Bengal, with its unique photodynamic properties, is positioned to capture a segment of this market, particularly in ophthalmic infections.

Competitive Landscape

The competitive landscape includes other photosensitizers like riboflavin, which is also used in photodynamic therapy. However, Rose Bengal's higher efficiency in generating ROS under green light activation gives it a competitive edge[2].

Regulatory Environment

Commercial-grade Rose Bengal has regulatory challenges due to its impurities and lack of modern diagnostic and therapeutic standards. However, pharmaceutical-grade Rose Bengal (HP-RB) is being developed to address these issues, which could streamline regulatory approvals for therapeutic applications[1].

Market Projections

Growth Potential

Given the increasing need for effective antimicrobial therapies and the promising results from clinical trials, Rose Bengal sodium I-131 is expected to see significant growth. The ophthalmic market, in particular, is likely to benefit from this treatment, especially for conditions like infectious keratitis.

Market Size and Share

While exact market size projections are not available, the antimicrobial therapy market is expected to grow substantially. Rose Bengal sodium I-131, with its unique mechanism and efficacy, is likely to capture a notable share of this growing market.

Key Takeaways

• Clinical Trials: Ongoing trials like the REAGIR study are evaluating the efficacy of Rose Bengal in treating infectious keratitis.
• Mechanism of Action: Rose Bengal generates ROS when activated by green light, making it effective against microorganisms.
• Market Analysis: The growing need for antimicrobial therapies and the competitive edge of Rose Bengal position it for significant market growth.
• Regulatory Environment: Pharmaceutical-grade Rose Bengal is being developed to meet modern regulatory standards.

FAQs

What is Rose Bengal sodium I-131 used for?

Rose Bengal sodium I-131 is primarily used in medical diagnostics and has potential therapeutic applications in antimicrobial and oncological treatments.

How does Rose Bengal photodynamic antimicrobial therapy work?

Rose Bengal generates reactive oxygen species (ROS) when activated by green light, which attack and kill microorganisms.

What are the current clinical trials focusing on?

Current clinical trials, such as the REAGIR study, are focusing on the use of Rose Bengal in treating infectious keratitis, including fungal and Acanthamoeba keratitis.

What are the regulatory challenges for Rose Bengal?

Commercial-grade Rose Bengal faces regulatory challenges due to its impurities and lack of modern standards. Pharmaceutical-grade Rose Bengal is being developed to address these issues.

What is the market potential for Rose Bengal sodium I-131?

The market potential is significant, particularly in the ophthalmic sector, due to the growing need for effective antimicrobial therapies and the promising results from clinical trials.

Sources

1. Antibacterial Activity of Pharmaceutical-Grade Rose Bengal - MDPI
2. Rose Bengal Photodynamic Antimicrobial Therapy for Infectious Keratitis - Corneal Physician
3. Cellectar Biosciences' Iopofosine I 131 Exceeds Primary Endpoint - Cellectar Biosciences
4. Medical Applications of Rose Bengal‐ and Riboflavin‐Photosensitized Protein Crosslinking - Wiley Online Library
5. Thermo Scientific Chemicals Rose Bengal - Fisher Scientific