CLINICAL TRIALS PROFILE FOR POLYSPORIN

All Clinical Trials for Polysporin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00294502 ↗	Antibiotic Lock Solutions in the Prevention of Catheter Related Bacteremia	Completed	Henry Ford Health System	Phase 4	2003-09-01	To study the efficacy of an antibacterial/anticoagulant solution instilled into the hemodialysis (HD) catheters after each treatment ("antibiotic lock solution - ALS") to prevent catheter related bacteremia (CRB) and to salvage catheters with established CRB.
NCT00400595 ↗	Use of Ointments in Prevention of Catheter Related Infections in PD	Completed	University Health Network, Toronto	Phase 4	2006-02-01	Peritoneal dialysis (PD) is used for the treatment of end-stage renal disease in approximately 25% of patients requiring dialysis in Canada. The most common complication is bacterial infection or 'peritonitis'. Peritonitis causes severe acute abdominal pain and may lead to failure of peritoneal dialysis treatment, hospitalization or death, particularly if left untreated. Amongst the strategies used to prevent peritonitis, patients are instructed on the regular use of a prophylactic ointment around the point where the catheter exits from the body. At the present time most centers in Canada routinely prescribe mupirocin ointment for use at the exit site, however newer ointments have become available. One such ointment is Polysporin Triple. The aim of this study is to determine if catheter related infections can be significantly reduced by the routine application of Polysporin Triple in comparison to mupirocin ointment. A multi-centre, randomized, double blind, controlled study is proposed. Participants will be randomized to either mupirocin or Polysporin Triple and followed for 18 months or until the first catheter related infection, death or catheter removal. The difference in catheter related infection rates will be compared between the two groups. We anticipate the results of this study will allow clinicians to prescribe the ointment most likely to reduce infections. By doing so this will reduce the complication rate associated with peritoneal dialysis and, ultimately improve survival.
NCT00695578 ↗	Clinical Trial to Evaluate Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy	Completed	Wake Forest University	Phase 4	2006-10-01	The purpose of this research study is to evaluate the use of Biafine Cream on wounds created by removal of actinic keratosis using cryotherapy in a clinical setting.
NCT00990392 ↗	Topical Antibiotics for Prevention of Intensive Care Unit (ICU) Central Line Infections	Withdrawn	Fraser Health	N/A	2009-11-01	The purpose of the study is to determine if the overall central venous catheter related infection rate can be reduced by the application of Polysporin Triple Therapy ointment to the insertion site.
NCT02663895 ↗	Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis	Completed	United Therapeutics	Phase 2	2016-10-01	This is a prospective open-label trial that will enroll 12 patients with systemic sclerosis (SSc) and at least one calcinotic lesion of the hands that is palpable on physical examination and also measureable on hand radiographs, at one single center. Each subject will receive treprostinil orally for 12 months, and follow-up evaluations will be performed every 3 months. Our main objective is to determine whether oral treprostinil is safe, and effective in reducing calcinosis in patients with SSc. We hypothesize that calcinosis is a result of microvascular injury and ischemic damage, and that therefore treprostinil may be beneficial in the treatment of calcinosis in patients with SSc.
NCT02663895 ↗	Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis	Completed	Stanford University	Phase 2	2016-10-01	This is a prospective open-label trial that will enroll 12 patients with systemic sclerosis (SSc) and at least one calcinotic lesion of the hands that is palpable on physical examination and also measureable on hand radiographs, at one single center. Each subject will receive treprostinil orally for 12 months, and follow-up evaluations will be performed every 3 months. Our main objective is to determine whether oral treprostinil is safe, and effective in reducing calcinosis in patients with SSc. We hypothesize that calcinosis is a result of microvascular injury and ischemic damage, and that therefore treprostinil may be beneficial in the treatment of calcinosis in patients with SSc.

Clinical Trial Conditions for Polysporin

Condition Name

Condition Name for Polysporin
Intervention	Trials
Actinic Keratosis	1
Blood Stream Infections	1
Calcinosis	1
Edema Face	1

Condition MeSH

Condition MeSH for Polysporin
Intervention	Trials
Infections	2
Infection	2
Scleroderma, Diffuse	1
Keratosis	1

Clinical Trial Locations for Polysporin

Trials by Country

Trials by Country for Polysporin
Location	Trials
Canada	3
United States	3

Trials by US State

Trials by US State for Polysporin
Location	Trials
California	1
North Carolina	1
Michigan	1

Clinical Trial Progress for Polysporin

Clinical Trial Phase

Clinical Trial Phase for Polysporin
Clinical Trial Phase	Trials
Phase 4	3
Phase 2/Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Polysporin
Clinical Trial Phase	Trials
Completed	4
Unknown status	1
Withdrawn	1

Clinical Trial Sponsors for Polysporin

Sponsor Name

Sponsor Name for Polysporin
Sponsor	Trials
Fraser Health	1
United Therapeutics	1
Stanford University	1

Sponsor Type

Sponsor Type for Polysporin
Sponsor	Trials
Other	6
Industry	1

Polysporin: Clinical Trials, Market Analysis, and Projections

Introduction to Polysporin

Polysporin is a topical antibiotic ointment that contains a combination of polymyxin B, bacitracin, and sometimes gramicidin. It is widely used for the prevention and treatment of minor skin infections and for promoting healing of minor cuts, scrapes, and burns.

Clinical Trials Involving Polysporin

Efficacy Against MRSA

One notable clinical trial compared the efficacy of Polysporin Triple Compound (PT) ointment with mupirocin in eradicating methicillin-resistant Staphylococcus aureus (MRSA) in a complex continuing care population. The study, conducted as a double-blind, randomized, controlled trial, involved applying either mupirocin or PT ointment to the anterior nares along with chlorhexidine body washes for seven days.

• The results showed that while both agents had poor overall efficacy, mupirocin was significantly more effective than PT ointment in eradicating MRSA at 48 hours and up to two weeks. However, this difference was not sustained at later intervals[1].

Use in Burn Wounds and Other Infections

Polysporin has also been studied in the context of burn wounds and other skin infections. For example, its components, such as polymyxin B and gramicidin, have been shown to have anti-biofilm activity and efficacy against various bacterial infections, including Pseudomonas aeruginosa in burn wounds[4].

Market Analysis of Polysporin

Global Burn Ointment Market

The global burn ointment market, which includes Polysporin, is experiencing significant growth. Here are some key market insights:

• Market Size and Growth: The global burn ointment market was valued at USD 862 million in 2021 and is expected to grow to USD 1.2 billion by 2030, at a CAGR of 5.7% during the forecast period 2022-2030[2].
• Regional Insights: North America is expected to dominate the market, driven by a well-established healthcare infrastructure and a high incidence of burns. The Asia Pacific region is also expected to grow rapidly due to the rise in burn wounds and supportive government programs[5].

Key Market Players

Polysporin is part of a competitive market with several key players, including:

• Johnson & Johnson (the manufacturer of Neosporin and Polysporin)
• B Braun Melsungen AG
• Coloplast A/S
• ConvaTec Group Plc
• Medline Industries, Inc.
• Smith & Nephew Plc[2].

Product Types and End Users

The burn ointment market, including Polysporin, is segmented by product types such as topical antibiotics, silver, and iodine. The end users include hospitals, clinics, and home care settings. Over-the-counter burn ointments like Polysporin are widely used for minor burns and skin infections[5].

Market Projections

Growth Drivers

The market for burn ointments, including Polysporin, is driven by several factors:

• Increasing Incidence of Burns: According to the American Burn Association, over 300 children are seen in emergency departments every day in the United States, and roughly two children die from burn injuries daily. This high incidence of burns drives the demand for burn ointments[5].
• Well-Established Healthcare Infrastructure: In regions like North America, the well-developed healthcare infrastructure supports the growth of the burn ointment market.
• Government Initiatives: Supportive government programs, such as the Asia Pacific Burn Congress, contribute to market growth in the Asia Pacific region[5].

Challenges and Opportunities

• Competition: The market is highly competitive, with several established players. However, this competition also drives innovation and better product offerings.
• Regulatory Environment: Changes in regulatory requirements can impact the market. For instance, stricter safety and efficacy standards can affect the approval and marketing of new products.
• Emerging Markets: The Asia Pacific region presents significant opportunities due to its large population and rising incidence of burn wounds[5].

Use of Polysporin in Clinical Settings

Hospital and Clinic Use

Polysporin is commonly used in hospitals and clinics for the treatment of minor skin infections and burns. Its broad-spectrum antibiotic properties make it a preferred choice for preventing infection in minor wounds.

Home Care

In addition to clinical settings, Polysporin is widely used in home care for treating minor cuts, scrapes, and burns. Its over-the-counter availability makes it accessible for general public use.

Side Effects and Safety

While Polysporin is generally safe, it can cause minor side effects such as blurred vision, watery eyes, and sensitivity to light, particularly when used in ophthalmic formulations. These side effects are typically associated with the combination of antimicrobial agents in the ointment[4].

Key Takeaways

• Clinical Efficacy: Polysporin has shown variable efficacy in clinical trials, particularly against MRSA, where it was less effective than mupirocin.
• Market Growth: The global burn ointment market, including Polysporin, is expected to grow significantly, driven by increasing incidence of burns and well-established healthcare infrastructure.
• Regional Dominance: North America is expected to dominate the market, with the Asia Pacific region showing rapid growth.
• Competition and Innovation: The market is highly competitive, driving innovation and better product offerings.

FAQs

What is Polysporin used for?

Polysporin is a topical antibiotic ointment used for the prevention and treatment of minor skin infections and for promoting healing of minor cuts, scrapes, and burns.

How effective is Polysporin against MRSA?

Polysporin was found to be less effective than mupirocin in eradicating MRSA in a clinical trial, particularly at later intervals after treatment[1].

What is the projected market size of the global burn ointment market by 2030?

The global burn ointment market is expected to reach USD 1.2 billion by 2030, growing at a CAGR of 5.7% during the forecast period 2022-2030[2].

Which region is expected to dominate the burn ointment market?

North America is expected to dominate the burn ointment market, driven by its well-established healthcare infrastructure and high incidence of burns[5].

What are the common side effects of Polysporin?

Common side effects of Polysporin include blurred vision, watery eyes, and sensitivity to light, particularly when used in ophthalmic formulations[4].

Who are the key market players in the burn ointment market?

Key market players include Johnson & Johnson, B Braun Melsungen AG, Coloplast A/S, ConvaTec Group Plc, and Medline Industries, Inc.[2].

Sources

1. O’Grady S, et al. A Double-Blind, Randomized, Controlled Trial of Topical Polysporin Triple Compound Versus Topical Mupirocin for the Eradication of Colonization with Methicillin-Resistant Staphylococcus aureus in a Complex Continuing Care Population. Onlinelibrary.wiley.com, 2009.
2. Spherical Insights. Global Burn Ointment Market Analysis, Outlook, Forecasts to 2030. Sphericalinsights.com.
3. Straits Research. Global Clinical Trials Market Size, Top Share, Trends, Forecast by 2033. Straitsresearch.com.
4. Frontiers in Microbiology. Review: Lessons Learned From Clinical Trials Using Antimicrobial Peptides. Frontiersin.org.
5. Maximize Market Research. Burn Ointment Market: Industry Analysis and Forecast (2023-2029). Maximizemarketresearch.com.