CLINICAL TRIALS PROFILE FOR HIBICLENS

505(b)(2) Clinical Trials for Hibiclens

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT04021524 ↗	BPO vs Hibiclens Soap for Surgical Preparation	Unknown status	University of Washington	Phase 4	2018-09-10	This is a randomized trial of benzoyl peroxide soap versus Hibiclens soap for surgical preparation. The objective is to determine whether benzoyl peroxide soap, commonly available in drug stores for over-the-counter acne treatment, is as or more effective than the standard surgical preoperative soap, Hibiclens soap (chlorhexidine gluconate), in reducing loads of Propionibacteria (Propi) on or under the skin of patients prior to shoulder arthroplasty (joint replacement).

All Clinical Trials for Hibiclens

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00513799 ↗	The Natural History of Community-Associated MRSA Infections and Decolonization Strategies	Completed	Washington University School of Medicine	N/A	2007-03-01	The purpose of this study is to determine the natural history of community-associated Staphylococcus aureus infections in both adult and pediatric patients by monitoring the rate of recurrent infections in those colonized with S. aureus. In addition, this study will evaluate the efficiency of commonly prescribed decolonization measures in patients presenting with S. aureus skin and soft tissue infections.
NCT00731783 ↗	Staphylococcus Aureus Decolonization Study	Completed	Washington University School of Medicine	N/A	2008-07-01	The purpose of this study is to determine whether measures to eliminate the Staph germ from the skin of the index patient (with a special ointment and soap) are more effective when performed by everyone in the household rather than the patient alone, and whether these methods are effective in preventing future Staph infections. The investigators hypothesize that there will be a greater number of households who are successful in eradicating the staph germ from the index patient when all members of the household participate than households where only the index patient is treated.
NCT00799812 ↗	Test for Pre Operative Skin Preparations	Completed	CareFusion	Phase 3	2007-11-13	Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens applied according to the manufacturer's directions. Sterile swabsticks (wetted with sterile deionizd water) applied using the same method as the ChloraPrep Swabstick.
NCT01196169 ↗	Daptomycin Use for Antimicrobial Prophylaxis in Methicillin Resistant Staphylococcus Aureus (MRSA) Colonized Adult Patients Undergoing Primary Elective Hip, Knee, or Shoulder Arthroplasty	Terminated	Cubist Pharmaceuticals LLC	Phase 4	2010-10-01	This study will evaluate the safety and effectiveness of daptomycin, an antibiotic compared to another one which is vancomycin when given around the time of joint replacement surgery. Vancomycin is recommended for perioperative prophylaxis in methicillin resistant Staphylococcus aureus (MRSA) colonized patients undergoing primary total joint arthroplasty. Daptomycin has not been recommended for this indication but it is FDA approved for treatment of MRSA blood stream and skin and soft tissue infections. Data collected during this study may support the use of daptomycin for this indication and may also be used for other research purposes that have not yet been specified.
NCT01196169 ↗	Daptomycin Use for Antimicrobial Prophylaxis in Methicillin Resistant Staphylococcus Aureus (MRSA) Colonized Adult Patients Undergoing Primary Elective Hip, Knee, or Shoulder Arthroplasty	Terminated	East Tennessee State University	Phase 4	2010-10-01	This study will evaluate the safety and effectiveness of daptomycin, an antibiotic compared to another one which is vancomycin when given around the time of joint replacement surgery. Vancomycin is recommended for perioperative prophylaxis in methicillin resistant Staphylococcus aureus (MRSA) colonized patients undergoing primary total joint arthroplasty. Daptomycin has not been recommended for this indication but it is FDA approved for treatment of MRSA blood stream and skin and soft tissue infections. Data collected during this study may support the use of daptomycin for this indication and may also be used for other research purposes that have not yet been specified.
NCT01196169 ↗	Daptomycin Use for Antimicrobial Prophylaxis in Methicillin Resistant Staphylococcus Aureus (MRSA) Colonized Adult Patients Undergoing Primary Elective Hip, Knee, or Shoulder Arthroplasty	Terminated	Mountain Home Research & Education Corporation	Phase 4	2010-10-01	This study will evaluate the safety and effectiveness of daptomycin, an antibiotic compared to another one which is vancomycin when given around the time of joint replacement surgery. Vancomycin is recommended for perioperative prophylaxis in methicillin resistant Staphylococcus aureus (MRSA) colonized patients undergoing primary total joint arthroplasty. Daptomycin has not been recommended for this indication but it is FDA approved for treatment of MRSA blood stream and skin and soft tissue infections. Data collected during this study may support the use of daptomycin for this indication and may also be used for other research purposes that have not yet been specified.
NCT01537783 ↗	Evaluation of a Staphylococcus Eradication Protocol for Patients Who Present to the ED With Cutaneous Abscess	Completed	Tufts Medical Center	Phase 4	2011-09-01	In this study, the investigators will enroll patients who present to the emergency department with abscesses to the study. The patients will be randomly selected to either have the standard of care, which includes the standard drainage of the abscess and then usually a follow-up visit to recheck the wound, or to have the standard of care plus instructions to use a topical scrub of a soap called chlorhexidine once a day for five days and twice daily application of a topical antibiotic ointment called mupirocin to the nasal passages for five days. The investigators will then call back the patients at 7 days, 14 days (if in the treatment arm), 3 months and 6 months, to ask if they have had any recurrence of abscess formation. The study hypothesis is that the patients who have undergone the decontamination protocol will have fewer subsequent infections.

Clinical Trial Conditions for Hibiclens

Condition Name

Condition Name for Hibiclens
Intervention	Trials
Staphylococcus Aureus	3
Staphylococcal Skin Infections	3
Abscesses	2
Furunculosis	2

Condition MeSH

Condition MeSH for Hibiclens
Intervention	Trials
Infections	7
Communicable Diseases	6
Staphylococcal Infections	5
Infection	5

Clinical Trial Locations for Hibiclens

Trials by Country

Trials by Country for Hibiclens
Location	Trials
United States	16

Trials by US State

Trials by US State for Hibiclens
Location	Trials
Missouri	4
Maryland	2
Tennessee	2
Virginia	2
Pennsylvania	1

Clinical Trial Progress for Hibiclens

Clinical Trial Phase

Clinical Trial Phase for Hibiclens
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Hibiclens
Clinical Trial Phase	Trials
Completed	8
Recruiting	4
Unknown status	2

Clinical Trial Sponsors for Hibiclens

Sponsor Name

Sponsor Name for Hibiclens
Sponsor	Trials
Washington University School of Medicine	3
Johns Hopkins University	2
Cystic Fibrosis Foundation Therapeutics	1

Sponsor Type

Sponsor Type for Hibiclens
Sponsor	Trials
Other	22
Industry	2
U.S. Fed	1

Hibiclens: Clinical Trials, Market Analysis, and Projections

Introduction to Hibiclens

Hibiclens is a widely trusted antiseptic skin cleanser containing 4% chlorhexidine gluconate (CHG). It has been a staple in healthcare settings for over 40 years, known for its efficacy in reducing hospital-acquired infections (HAIs) and its safety profile.

Clinical Trials and Efficacy

Reducing Hospital-Acquired Infections

Clinical studies have consistently shown that Hibiclens, with its 4% CHG solution, is highly effective in reducing facility infection rates. This antiseptic skin cleanser begins to kill germs on contact and continues to provide protection even after washing, making it a crucial component in infection prevention strategies[4].

Specific Use Cases

Hibiclens is versatile and can be used in various settings within a hospital facility, including:

• Daily patient bed baths
• Preoperative and postoperative showering and decolonization
• Surgical hand scrubbing
• Personnel hand washing
• Preoperative skin preparation

These uses highlight its broad applicability in preventing infections across different hospital procedures[4].

Recent Studies on CHG

While specific to Hibiclens, recent studies on CHG, such as the NeoCHG trial, provide valuable insights into the broader efficacy and safety of chlorhexidine gluconate. The NeoCHG trial, for instance, investigated the use of whole-body CHG application in reducing bacterial skin colonization in hospitalized low birth weight neonates. The trial found no immediate skin problems and indicated that CHG could be safely used in vulnerable populations, although it did not identify a significantly better treatment regimen among the tested concentrations and frequencies[1].

Market Analysis

Global Wound Cleanser Products Market

The global wound cleanser products market, which includes antiseptic solutions like Hibiclens, was estimated at USD 2.12 billion in 2024 and is projected to grow at a CAGR of 4.80% from 2025 to 2030. This growth is driven by factors such as the increasing prevalence of chronic diseases, technological advancements, and the rise in ambulatory surgical centers[2].

Segment Performance

Within this market, the wipes segment, which includes premioistened and individually packaged wound cleansing wipes, is expected to register the fastest CAGR. Antiseptic solutions, such as those containing benzalkonium chloride or povidone-iodine, are key components of these wipes, similar to the active ingredient in Hibiclens[2].

Regional Market

The U.S. holds a significant revenue share in the wound cleanser products market, driven by the rising prevalence of diabetes, novel product launches, and the presence of key industry players. This regional focus is relevant for Hibiclens, as it is currently approved only for distribution and use in the U.S.[2].

Market Projections

Growth Drivers

The market for wound cleanser products, including antiseptics like Hibiclens, is expected to grow due to several key drivers:

• Increasing Prevalence of Chronic Diseases: Conditions such as diabetes, which is a primary cause of 1.5 million deaths per year, drive the demand for effective wound care solutions[2].
• Technological Advancements: New products and technologies, such as the HOClean Technology used in Renovar, are enhancing wound healing processes and reducing infection risks[2].
• Regulatory Approvals: Products like VeriCyn Wound Wash, which obtained FDA clearance, indicate a favorable regulatory environment for innovative wound care solutions[2].

Challenges and Opportunities

Despite the positive growth projections, there are challenges to consider:

• Regulatory Hurdles: The development of new nasal decolonization drugs and other antiseptics faces strict regulatory measures, which can delay market entry and increase development costs[3].
• Antimicrobial Resistance: The growing concern over antimicrobial resistance highlights the need for effective and safe antiseptics like Hibiclens, which have a proven track record in infection control[3].

Future Outlook

Continued Innovation

The future of Hibiclens and similar antiseptic solutions looks promising, with ongoing research and development aimed at enhancing their effectiveness and safety. For example, the NeoCHG trial's findings on the use of CHG in neonates could inform future studies on broader applications of CHG in different patient populations[1].

Expanding Applications

As the healthcare landscape evolves, antiseptics like Hibiclens are likely to see expanded use in various settings, including home care and ambulatory surgical centers. The versatility of Hibiclens, combined with its proven efficacy, positions it well for continued market growth[4].

Key Takeaways

• Proven Efficacy: Hibiclens has a long history of reducing hospital-acquired infections and is widely trusted in healthcare settings.
• Market Growth: The global wound cleanser products market is projected to grow at a CAGR of 4.80% from 2025 to 2030, driven by increasing chronic diseases and technological advancements.
• Regulatory Environment: Strict regulations can delay market entry but ensure the safety and efficacy of new products.
• Future Outlook: Ongoing research and the expanding use of antiseptics in various healthcare settings indicate a bright future for products like Hibiclens.

FAQs

What is Hibiclens used for?

Hibiclens is used as an antiseptic skin cleanser to reduce bacteria that can cause disease. It is used in various hospital settings, including daily patient bed baths, preoperative and postoperative showering, surgical hand scrubbing, and personnel hand washing[4].

Is Hibiclens safe for everyday use?

Yes, Hibiclens is safe for everyday use. It has been trusted by healthcare professionals for over 40 years and has a proven safety profile[5].

Can Hibiclens be used outside the U.S.?

No, Hibiclens is currently only approved for distribution and use in the U.S.[5].

What are the different forms of Hibiclens available?

Hibiclens is available in various forms, including 4 oz, 8 oz, 16 oz with pump, packettes, and a gallon. The formula remains the same across all products, with differences only in bottle sizes and dispensing methods[4].

How does Hibiclens compare to other antiseptic solutions?

Hibiclens stands out due to its 4% CHG solution, which begins to kill germs on contact and continues to provide protection even after washing. This makes it highly effective in reducing facility infection rates compared to other antiseptic solutions[4].

References

1. NeoCHG: efficacy and safety of chlorhexidine gluconate skin application for sepsis in neonates - Touch Infectious Diseases, 2023.
2. Wound Cleanser Products Market Size | Industry Report, 2030 - Grand View Research.
3. Nasal Decolonization Drug Market 2024 - Market Statsville Group - Market Statsville Group.
4. Hibiclens 4% chlorhexidine gluconate CHG surgical site - Mölnlycke.
5. Frequently Asked Questions - Hibiclens - Hibiclens.

Last updated: 2025-01-01