CLINICAL TRIALS PROFILE FOR SILVER SULFADIAZINE

All Clinical Trials for Silver Sulfadiazine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00156988 ↗	The Effect of Two Versus Ten Days Application of Flammacerium in Partial Thickness Burns	Completed	Dutch Burns Foundation	Phase 4	2004-03-01	The objective of the proposed study is to assess whether the application of flammacerium for 2 days is as good as, or even better than, the application of flammacerium for 10 days regarding woundhealing in partial thickness burns.
NCT00156988 ↗	The Effect of Two Versus Ten Days Application of Flammacerium in Partial Thickness Burns	Completed	Association of Dutch Burn Centres	Phase 4	2004-03-01	The objective of the proposed study is to assess whether the application of flammacerium for 2 days is as good as, or even better than, the application of flammacerium for 10 days regarding woundhealing in partial thickness burns.
NCT00641433 ↗	Topical Collagen-Silver Versus Standard Care Following Removal of Ingrown Nails	Unknown status	Rosalind Franklin University of Medicine and Science	N/A	2005-11-01	This study's purpose is to prospectively determine whether topical therapy with an oxidized regenerated cellulose collagen-silver compound is more effective than the current standard of topical antibiotic therapy for care following the removal of an ingrown toenail. Eighty adult patients with ingrown toenails will be recruited. Each patient will randomly be assigned to apply either topical silver sulfadiazine cream (standard antibiotic) or the novel collagen-silver compound to their nail bed daily, following removal of the ingrown portion of nail. Patients will return for follow up visits weekly, until healing has occurred or twelve weeks have passed. Healing will be defined as resolution of drainage and inflammatory changes surrounding the nail border.
NCT00798083 ↗	Neuropathic Pain Caused by Radiation Therapy	Completed	British Columbia Cancer Agency	Phase 3	2008-04-01	To investigate if topical amitriptyline 2%, ketamine 1%, and lidocaine 5% in pluronic lecitine organogel (AKL in PLO gel) can improve management of neuropathic pain from radiation skin reactions adjunctively or better than standard treatment.
NCT01297400 ↗	Phase 2, Open Label, Randomized, Active Controlled Pilot Study MW-III vs Silver Sulfadiazine Second Degree Thermal Burns	Not yet recruiting	Skingenix, Inc.	Phase 2	2022-01-12	To compare MW-III to Silvadene® Cream 1% (Silver Sulfadiazine) with respect to "time to healing" in second-degree thermal burns
NCT01439074 ↗	Mepilex Ag Versus Silver Sulfadiazine in Children and Adults With Burn Injuries.	Completed	Molnlycke Health Care AB	N/A	2011-09-01	The purpose is to compare time to healing using absorbent foam silver dressing (Mepilex Ag) compared to a silver sulfadiazine (SSD) 1% cream in the treatment of partial thickness burn injuries.284 in-patients in 8-12 centres in China will be evaluated. Treatment period will be up to 4 weeks with either Mepilex Ag or SSD.

Clinical Trial Conditions for Silver Sulfadiazine

Condition Name

Condition Name for Silver Sulfadiazine
Intervention	Trials
Burns	5
Burn	2
Ingrown Nail	1
Neuropathic Pain Secondary to Radiation Therapy	1

Condition MeSH

Condition MeSH for Silver Sulfadiazine
Intervention	Trials
Burns	12
Wounds and Injuries	2
Infections	1
Breast Neoplasms	1

Clinical Trial Locations for Silver Sulfadiazine

Trials by Country

Trials by Country for Silver Sulfadiazine
Location	Trials
China	6
United States	6
Brazil	3
Netherlands	1
Philippines	1

Trials by US State

Trials by US State for Silver Sulfadiazine
Location	Trials
Virginia	2
Pennsylvania	1
Kentucky	1
Illinois	1
Oregon	1

Clinical Trial Progress for Silver Sulfadiazine

Clinical Trial Phase

Clinical Trial Phase for Silver Sulfadiazine
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Silver Sulfadiazine
Clinical Trial Phase	Trials
Completed	11
Unknown status	3
Not yet recruiting	2

Clinical Trial Sponsors for Silver Sulfadiazine

Sponsor Name

Sponsor Name for Silver Sulfadiazine
Sponsor	Trials
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara	3
University of Louisville	1
J. Peter Rubin, MD	1

Sponsor Type

Sponsor Type for Silver Sulfadiazine
Sponsor	Trials
Other	22
Industry	3
U.S. Fed	1

Silver Sulfadiazine: Clinical Trials, Market Analysis, and Projections

Introduction

Silver sulfadiazine, a small molecule drug, has been a staple in the treatment of burn wounds for decades. However, its efficacy and market dynamics are subjects of ongoing debate and research. Here, we delve into the current state of clinical trials, market analysis, and future projections for silver sulfadiazine.

Clinical Trials Update

Silver sulfadiazine is currently involved in several clinical trials, reflecting the ongoing interest in its therapeutic potential and limitations.

• Active Clinical Trials: As of the latest updates, there are multiple clinical trials associated with silver sulfadiazine, focusing on its use in burn injuries and wound care. These trials are crucial for understanding the drug's efficacy, safety, and potential side effects[1].
• Recent Findings: A study published in the Journal of Investigative Dermatology challenged the long-held view of silver sulfadiazine as the gold standard for wound healing. The study found that silver sulfadiazine actually delayed wound closure in mice, suggesting a mechanism where it impairs wound healing by altering gene expression and cytokine production[4].

Mechanism and Therapeutic Areas

Mechanism of Action

Silver sulfadiazine acts as a DNA modulator, exerting its antimicrobial effects by inhibiting bacterial DNA replication. This mechanism is crucial for preventing infections in burn wounds[1].

Therapeutic Areas

The primary therapeutic area for silver sulfadiazine is the treatment of burn injuries. It is widely used in hospitals, particularly in North America, due to its antimicrobial properties[5].

Market Analysis

Global Market Size and Trends

The global silver sulfadiazine market is expected to grow significantly during the forecast period (2019-2027). This growth is driven by the high incidence of burn injuries, which are a severe healthcare problem, especially in emerging economies. According to the World Health Organization, around 180,000 deaths occur due to burns annually, primarily in these regions[2][5].

Regional Market Outlook

• North America: This region is anticipated to hold the largest market share due to the high demand for wound-care products and increased burn cases. Government initiatives to fund research and development of burn wound treatments also contribute to this growth[5].
• Asia Pacific: Emerging economies such as India and China are expected to drive significant growth in this region, making countries like Australia, China, and India new revenue generators[5].

Market Players

Key players in the global silver sulfadiazine market include 3M Company, Baxter International, Inc., Monarch Pharmaceuticals, Teva Pharmaceutical Industries Ltd, and Johnson & Johnson Limited. These companies play a crucial role in manufacturing and distributing silver sulfadiazine products[5].

Side Effects and Limitations

Despite its widespread use, silver sulfadiazine is associated with several minor side effects that could impact its market growth.

• Side Effects: Common side effects include nausea, loss of appetite, and dizziness. These adverse effects may deter some patients and healthcare providers from using the drug[2][5].
• Raw Material Costs: The increasing price of silver, a key raw material in the production of silver sulfadiazine, is another factor that could hinder market growth[2].

Criticisms and Alternatives

Criticisms of Efficacy

Recent studies have questioned the efficacy of silver sulfadiazine in wound healing. Dr. Adam Friedman, director of dermatologic research at Albert Einstein College of Medicine, suggests that silver sulfadiazine may actually delay wound healing and recommends stopping its use based on the study findings[4].

Alternatives

The search for more effective alternatives is ongoing. For instance, nanotechnology-based treatments have shown promising results in accelerating wound healing compared to silver sulfadiazine[4].

Future Projections

Market Growth

Despite the criticisms, the global silver sulfadiazine market is expected to continue growing due to the high demand for anti-burn creams and lotions. However, the growth may be tempered by the increasing costs of raw materials and the emergence of alternative treatments[2][5].

Research and Development

Ongoing research and clinical trials will be crucial in determining the future role of silver sulfadiazine in wound care. There is a need for further investigations to fully understand its mechanisms and to identify better treatment options[4].

Key Takeaways

• Clinical Trials: Ongoing trials are evaluating the efficacy and safety of silver sulfadiazine, with some studies questioning its traditional status as a gold standard.
• Market Growth: The global market is expected to grow, driven by high demand in regions with significant burn injury cases.
• Side Effects and Limitations: Minor side effects and increasing raw material costs could impact market growth.
• Criticisms and Alternatives: Recent studies suggest that silver sulfadiazine may not be as effective as previously thought, and alternative treatments are being explored.

FAQs

What is the primary use of silver sulfadiazine?

Silver sulfadiazine is primarily used for the treatment of burn injuries due to its antimicrobial properties.

What are the common side effects of silver sulfadiazine?

Common side effects include nausea, loss of appetite, and dizziness.

Why is the global silver sulfadiazine market expected to grow?

The market is expected to grow due to the high incidence of burn injuries, especially in emerging economies, and the increasing demand for wound-care products.

What are the criticisms against the use of silver sulfadiazine?

Recent studies suggest that silver sulfadiazine may delay wound healing and recommend stopping its use in favor of more effective alternatives.

Who are the key players in the global silver sulfadiazine market?

Key players include 3M Company, Baxter International, Inc., Monarch Pharmaceuticals, Teva Pharmaceutical Industries Ltd, and Johnson & Johnson Limited.

Sources

1. Synapse: Silver Sulfadiazine - Drug Targets, Indications, Patents.
2. Coherent Market Insights: Silver Sulfadiazine Market Size and Trends.
3. Biospace: U.S. Clinical Trials Market Size Industry Analysis Report, 2033.
4. Dermatology Times: Study finds silver sulfadiazine to be far from gold-standard.
5. Coherent Market Insights: Silver Sulfadiazine Market - Share, Size and Industry Analysis.