CLINICAL TRIALS PROFILE FOR ALCOHOL; CHLORHEXIDINE GLUCONATE

505(b)(2) Clinical Trials for ALCOHOL; CHLORHEXIDINE GLUCONATE

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
New Formulation	NCT01349140 ↗	EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks	Completed	Pacira Pharmaceuticals, Inc	Phase 1	2012-02-01	EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
New Formulation	NCT01349140 ↗	EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks	Completed	University of California, San Diego	Phase 1	2012-02-01	EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.

All Clinical Trials for ALCOHOL; CHLORHEXIDINE GLUCONATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00247897 ↗	Comparing Skin Disinfectants Before Labour Epidural Analgesia	Completed	University of British Columbia	N/A	2005-11-01	The purpose of this study is to compare the current standard skin disinfectant solution for labour epidurals used at BC Women's Hospital to another common skin disinfectant and to the skin disinfectant solution recommended by the Public Health Agency of Canada (PHAC) prior to placing special intravenous lines. There is very little information available to guide doctors in deciding which is the best skin disinfectant for epidural analgesia. The study hypothesis is that the disinfectant solution recommended by the PHAC will be the most effective.
NCT00610324 ↗	Effect of Oral Decontamination Using Chlorhexidine or Potassium Permanganate in ICU Patients	Completed	King Edward Memorial Hospital	Phase 4	2004-05-01	Oropharyngeal bacteria play an important role in the pathogenesis of nosocomial pneumonia in critically ill patients. Oral cleansing with chlorhexidine has been shown to decrease incidence of pneumonia in patients undergoing open heart surgery. Its role in critically ill general ICU patients is not yet proven. The present study proposes to study the effectiveness of twice-daily oral cleansing with 0.2% chlorhexidine solution on the incidence of nosocomial pneumonia in ICU patients admitted to a single intensive care unit of an Indian public hospital
NCT00739583 ↗	Visibility of Site Marking for Surgical Time Out With Two Different Skin Preparation Solutions	Completed	Johns Hopkins University	Phase 4	2008-08-01	Skin preparation solutions are used to clean the skin of the patient before surgery to decrease the rate of infection. This is particularly important for hip replacement to reduce the risk of prosthetic joint infection. The use of a mark on the skin for site identification has become the standard of care to decrease wrong site surgery. The Joint Commission has mandated site identification as part of the surgical "time-out". This procedure is also mandated by hospital policy. Preliminary work on cadaveric skin shows that the type of skin preparation can erase the mark used for surgical site identification. Erasure of the mark presents the surgeon with difficulty in performing the site identification. Any error or lack of visualization of the site marking could lead to catastrophic wrong site surgery. The investigators hypothesis is that chlorhexidine based skin preparation solutions erase site marking in comparison to iodine based skin preparation solutions. The investigators intend to prospectively study twenty patients undergoing total hip arthroplasty. Patients will be randomized to either a chlorhexidine based or an iodine based skin preparation solution. These solutions are both the current gold standard of clinical care. No differences have been shown in infection rates for total hip arthroplasty between these solutions. The site marking will be performed by the same surgeon in a standardized manner. The site marking will include the surgeon's three initials as per usual routine. Underneath the initials three random initials will be placed with a horizontal line drawn underneath. The preparation of the skin will be performed according to the manufacturer's specifications. Digital photographs will be taken of the skin marking after skin preparation. Photographs of the three random initials will be de-identified and placed in a "Powerpoint" presentation form. Ten orthopaedic surgeons will then read the site markings to identify the random initials and to tell whether the mark looks appropriate to perform a surgical timeout. The horizontal line will be digitally analyzed using Adobe Photoshop to quantitatively measure blackness of the mark.
NCT00829023 ↗	Efficacy of Surgical Preparation Solutions in Shoulder Surgery	Completed	CareFusion	N/A	2007-06-01	The purpose of the present study was to examine the native bacteria around the shoulder and determine the efficacy of three different surgical skin-preparation solutions on the eradication of bacteria from the shoulder.

Clinical Trial Conditions for ALCOHOL; CHLORHEXIDINE GLUCONATE

Condition Name

Condition Name for ALCOHOL; CHLORHEXIDINE GLUCONATE
Intervention	Trials
Surgical Site Infection	4
Bacteremia	3
Breast Surgery	3
Trauma Injury	2

Condition MeSH

Condition MeSH for ALCOHOL; CHLORHEXIDINE GLUCONATE
Intervention	Trials
Infections	6
Bacteremia	5
Surgical Wound Infection	5
Infection	5

Clinical Trial Locations for ALCOHOL; CHLORHEXIDINE GLUCONATE

Trials by Country

Trials by Country for ALCOHOL; CHLORHEXIDINE GLUCONATE
Location	Trials
United States	21
Canada	4
Thailand	1
France	1
Turkey	1

Trials by US State

Trials by US State for ALCOHOL; CHLORHEXIDINE GLUCONATE
Location	Trials
California	7
Illinois	3
Ohio	2
Pennsylvania	2
Texas	2

Clinical Trial Progress for ALCOHOL; CHLORHEXIDINE GLUCONATE

Clinical Trial Phase

Clinical Trial Phase for ALCOHOL; CHLORHEXIDINE GLUCONATE
Clinical Trial Phase	Trials
Phase 4	19
Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ALCOHOL; CHLORHEXIDINE GLUCONATE
Clinical Trial Phase	Trials
Completed	20
Recruiting	5
Not yet recruiting	5

Clinical Trial Sponsors for ALCOHOL; CHLORHEXIDINE GLUCONATE

Sponsor Name

Sponsor Name for ALCOHOL; CHLORHEXIDINE GLUCONATE
Sponsor	Trials
University of California, San Diego	9
Sunnybrook Health Sciences Centre	2
Northwestern University	2

Sponsor Type

Sponsor Type for ALCOHOL; CHLORHEXIDINE GLUCONATE
Sponsor	Trials
Other	43
Industry	5
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projections for Chlorhexidine Gluconate

Last updated: October 28, 2025

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Introduction

Chlorhexidine Gluconate (CHG) remains a cornerstone antimicrobial agent, predominantly used in healthcare settings as an antiseptic and disinfectant. Its utility in oral health, surgical skin preparation, and wound care underscores its significance. As pathogens evolve and resistance patterns shift, ongoing clinical trials aim to optimize its application, while market dynamics reflect changing demands across healthcare sectors. This analysis provides an up-to-date review of clinical trial activities, market trends, and future projections for Chlorhexidine Gluconate, synthesizing current data and strategic insights for industry stakeholders.

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Clinical Trials Update

Ongoing Trials and Their Focus

Recent years have seen a substantial increase in clinical investigations surrounding Chlorhexidine Gluconate, particularly exploring its efficacy against emerging resistant organisms and alternative delivery systems.

• Infection Prevention in COVID-19 Contexts: Several trials evaluate the role of CHG in reducing viral loads in healthcare settings amid SARS-CoV-2 concerns. For instance, a trial registered under ClinicalTrials.gov (NCT04846923) assesses its efficacy in preoperative skin prep during the pandemic, aiming to reduce intraoperative viral transmission.

• Biofilm Disruption and Resistance: A growing research focus involves the ability of CHG to prevent biofilm formation, a critical factor in device-associated infections. Trials such as NCT03814702 investigate enhanced formulations aimed at overcoming biofilm resistance.

• Oral Care and Periodontal Disease: Numerous studies evaluate CHG mouthwashes' long-term safety and efficacy in periodontal therapy, including randomized controlled trials like NCT02378086.

• Novel Formulations and Delivery Systems: Enhancements in formulation, including slow-release patches and biodegradable coatings, are explored in trials like NCT04587745, to prolong antimicrobial activity while mitigating side effects.

Regulatory and Approval Developments

While chlorhexidine formulations like CHG mouthwashes and skin prep solutions are FDA-approved with established safety profiles, newer formulations driven through clinical trials are progressing towards regulatory review. The U.S. Food and Drug Administration (FDA) continues to scrutinize efficacy claims, especially for products claiming enhanced biofilm removal or extended activity.

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Market Analysis

Market Size and Segmentation

The global chlorhexidine market was valued at approximately USD 250 million in 2022, with a compound annual growth rate (CAGR) projected at 5.2% through 2028.[1] The broad application spectrum underpins this growth:

• Oral Healthcare: The dominant segment, accounting for nearly 45% of the market. The widespread use of CHG mouthwashes for periodontitis and peri-implantitis drives steady demand.
• Surgical and Skin Disinfection: Representing about 30%, boosted by infection control protocols within hospitals and clinics.
• Wound Care and Other Applications: Encompassing products for incontinence-associated dermatitis and wound cleansing, contributing around 15%.
• Emerging Segments: Novel formulations (e.g., slow-release patches) and institutional prophylaxis represent the remaining growth avenues.

Key Market Players

Leading pharmaceutical companies include:

• 3M Healthcare: Noted for its Hexachlorophene-based products and skin antiseptics.
• Johnson & Johnson: Markets a range of CHG-based oral rinses (e.g., Peridex).
• Chlorhex Technologies: Specializes in innovative delivery systems.
• Local and Regional Manufacturers: Addressing specific institutional needs, especially in Asia-Pacific, which constitutes over 40% of global demand.

Regulatory Environment

Stringent regulations govern antiseptic claims due to concerns over antimicrobial resistance and toxicity. Agencies like the FDA and EMA require robust clinical efficacy data. Recent regulatory reviews focus on the safety profile of chlorhexidine, particularly regarding potential adverse effects like hypersensitivity and oral staining.

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Market Drivers and Challenges

Drivers:

• Increasing emphasis on infection prevention, especially in hospitals battling multidrug-resistant organisms (MDROs).
• Expansion of oral health programs in aging populations, especially in developed countries.
• Innovation in formulation technology improving compliance and extending antimicrobial activity.
• Rising awareness of biofilm-associated infections and the need for effective antiseptics.

Challenges:

• Concerns over chlorhexidine-associated adverse effects, such as oral staining, taste disturbances, and rare hypersensitivity reactions.
• Antimicrobial resistance emerging from sub-optimal use, necessitating cautious deployment.
• Regulatory hurdles for new formulations and delivery systems.
• Competition from alternative antiseptics and emerging antimicrobial agents.

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Future Market Projections

The chlorhexidine market is poised for steady growth, with a projected CAGR of approximately 5% from 2023 to 2030. Key drivers include innovative formulations and expanding applications.

Opportunities:

• Oral Health: Aging populations and increasing prevalence of periodontal diseases will sustain demand for CHG oral rinses—projected to reach USD 150 million by 2030.
• Infection Control in Hospitals: Emphasis on preoperative skin preparation, with a move towards higher-concentration formulations for rapid microbial kill, could augment market size.
• Development of Sustained-Release Systems: These could reduce usage frequency, improve compliance, and enable targeted applications, broadening market appeal.
• Global Expansion: Rising healthcare investments in Asia-Pacific, Latin America, and Africa create sizable growth prospects.

Risks and Considerations:

• Antimicrobial stewardship’s influence could limit overuse, tempering future growth.
• Potential regulatory constraints may inhibit rapid adoption of novel formulations.
• Market saturation in mature segments like oral healthcare could slow expansion unless differentiated products are introduced.

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Strategic Implications for Industry Stakeholders

• Invest in Clinical Validation: Demonstrate superior efficacy and safety for innovative formulations to meet regulatory standards and penetration goals.
• Focus on Geographical Expansion: Especially in emerging markets where healthcare infrastructure investments are rising.
• Balance Innovation with Stewardship: Develop formulations minimizing resistance development and adverse effects.
• Leverage Digital and Data Analytics: Use real-world evidence (RWE) to inform regulatory submissions and marketing strategies.

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Key Takeaways

• Clinical trials for Chlorhexidine Gluconate are increasingly focused on biofilm disruption, resistance mitigation, and novel delivery methods, indicating a strategic shift towards enhanced efficacy and safety.
• The global CHG market is expected to grow at a steady pace, driven primarily by oral health, infection control, and innovative formulations.
• Regulatory scrutiny is intensifying, emphasizing safety and antimicrobial stewardship, which will influence product development trajectories.
• Emerging markets present significant opportunities, yet face challenges related to regulation and local healthcare infrastructure.
• Innovators should prioritize clinical validation, regulatory compliance, and geographic diversification to capitalize on future growth prospects.

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FAQs

1. What are the latest developments in Chlorhexidine Gluconate clinical research?
Recent trials are exploring its antiviral potential in COVID-19, biofilm resistance mechanisms, and the efficacy of sustained-release formulations to enhance antimicrobial persistence.

2. How is the market for chlorhexidine expected to change over the next decade?
The market is projected to grow at approximately 5% annually, driven by innovations in formulation, expanding applications, and increased adoption in emerging markets.

3. What are the primary challenges facing chlorhexidine-based products?
Regulatory hurdles, resistance concerns, adverse effects like staining and hypersensitivity, and competition from alternative antiseptics.

4. Which regions are most promising for chlorhexidine market expansion?
Asia-Pacific and Latin America are emerging as key growth regions owing to increased healthcare investments and rising chronic disease burdens.

5. What innovations could shape the future of chlorhexidine formulations?
Sustained-release patches, biodegradable coatings, alcohol-free formulations, and targeted delivery systems hold significant potential for market differentiation.

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References

[1] MarketsandMarkets. "Chlorhexidine Market by Application, Formulation, and Region – Global Forecast to 2028." 2022.