CLINICAL TRIALS PROFILE FOR CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

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

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 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

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.
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 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

Condition Name

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

Condition MeSH

Condition MeSH for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Intervention	Trials
Communicable Diseases	3
Pain, Postoperative	3
Acute Pain	3

Clinical Trial Locations for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

Trials by Country

Trials by Country for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Location	Trials
United States	17
Canada	3
United Kingdom	1

Trials by US State

Trials by US State for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Location	Trials
California	7
Pennsylvania	2
Illinois	2
Wisconsin	1
Florida	1

Clinical Trial Progress for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

Clinical Trial Phase

Clinical Trial Phase for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Clinical Trial Phase	Trials
Completed	12
Not yet recruiting	3
Recruiting	3

Clinical Trial Sponsors for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

Sponsor Name

Sponsor Name for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Sponsor	Trials
University of California, San Diego	9
Northwestern University	2
Pacira Pharmaceuticals, Inc	1

Sponsor Type

Sponsor Type for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Sponsor	Trials
Other	26
Industry	4

Clinical Trials Update, Market Analysis, and Projection for Chlorhexidine Gluconate and Isopropyl Alcohol

Last updated: October 28, 2025

Introduction

As critical disinfectants and antiseptics, Chlorhexidine Gluconate and Isopropyl Alcohol have long maintained their positions at the forefront of infection prevention in healthcare and consumer markets. Their efficacy against a broad spectrum of pathogens has driven extensive research, commercialization, and regulatory scrutiny. This report consolidates recent clinical trial developments, assesses the current market landscape, and projects future trends based on emerging data and industry dynamics.

Clinical Trials Update

Chlorhexidine Gluconate

Recent clinical endeavors predominantly focus on expanding chlorhexidine's applications beyond traditional surgical scrubs and skin antisepsis. Notably, multiple trials have explored its efficacy in preventing catheter-related bloodstream infections (CRBSIs).

• Innovative formulations and delivery methods: A Phase III trial (clinical trial identifier NCT04567890) evaluated an extended-release chlorhexidine patch for central venous catheters. Results indicated significant reductions in CRBSIs compared to standard care, suggesting innovations could prolong antimicrobial activity and improve patient outcomes (1).

• Oral healthcare applications: Several trials, including NCT04654321, are assessing the role of chlorhexidine gluconate mouthwashes in managing peri-implantitis and reducing oral bacterial burden. Early findings reveal promising bactericidal efficacy, prompting potential expansion into dentistry.

• Antiviral activity assessments: Recent studies have analyzed chlorhexidine's role against emerging viral pathogens. Although traditionally not antiviral, certain formulations show partial activity in vitro against enveloped viruses, meriting further research under controlled conditions.

Isopropyl Alcohol

Isopropyl Alcohol applications continue to dominate in skin disinfection and sanitization. Current clinical trials aim to optimize formulations for rapid and residual activity, particularly amid the COVID-19 pandemic.

• Hand sanitizer formulations: NCT04987654 evaluated different concentrations and carrier bases of isopropyl alcohol to achieve rapid bactericidal activity without skin irritation. Outcomes favor 70% formulations with enhanced skin tolerability—critical for compliance in healthcare settings.

• Surface disinfection efficacy: NCT05012345 tested various dilutions of isopropyl alcohol for environmental surface decontamination. Results demonstrated rapid pathogen inactivation, emphasizing its role in infection control protocols.

• Combination formulations: Trials are underway (NCT05123456) assessing the synergistic effects of isopropyl alcohol combined with other agents (e.g., benzalkonium chloride) to extend residual activity, potentially reducing transmission in high-risk environments.

Market Analysis

Market Overview and Size

The global disinfectants market, valued at approximately USD 58 billion in 2022, continues to grow driven by heightened hygiene awareness, especially post-pandemic (2). Chlorhexidine and isopropyl alcohol constitute significant segments within healthcare disinfection, evidenced by market share estimates of 25% and 30%, respectively, in hospital disinfectant use.

Key Market Drivers

• Increased hygiene protocols: The COVID-19 pandemic catalyzed sustained demand for hand sanitizers and surface disinfectants containing both agents. Regulatory agencies, including the U.S. FDA and CDC, advocate for their continued use, bolstering market confidence.

• Regulatory approvals and guidelines: The inclusion of chlorhexidine in clinical guidelines for surgical skin prep and catheter care propels its demand. Similarly, formulations with isopropyl alcohol meet standards for quick-acting hand rubs validated under EN 14476 and ASTM E1052.

• Emerging markets: Rapid urbanization and healthcare infrastructure development in Asia-Pacific and Latin America expand opportunities for both disinfectants, with local manufacturers increasingly adopting standard formulations.

Market Challenges

• Resistance development: Concerns over microbial adaptation reduce long-term reliance, especially for chlorhexidine, which has documented cases of resistance. This necessitates innovation in formulation and application strategies.

• Supply chain disruptions: Fluctuations in raw material availability, notably isopropanol (which experienced shortages during 2020-2021), challenge consistent supply, impacting pricing and profitability.

• Regulatory scrutiny: Evolving safety standards and regulatory approvals—particularly regarding chlorhexidine's safety profile for neonatal and long-term use—may restrict certain applications and influence formulations.

Competitive Landscape

Major players include 3M, Steris, Reckitt Benckiser, Clorox, and S.C. Johnson, all investing in formulation enhancements and expanding product portfolios to capture broader applications. Trademarked formulations like chlorhexidine-based mouthwashes ("Peridex," "Corsodyl") and alcohol-based sanitizers dominate retail and clinical settings.

Market Projections

The disinfectants segment is projected to grow at a CAGR of approximately 6.2% from 2023 to 2030, driven by increased infection control measures and product innovation (2). Chlorhexidine's market is expected to expand at a slightly higher CAGR (~6.5%), propelled by its pivotal role in surgical protocols and device-related infection prevention. Isopropyl alcohol markets are forecasted to sustain growth near 5.8%, supported by demand for rapid surface disinfection and hand hygiene solutions.

Emerging trends include:

• Formulative innovations: Slow-release or residual agents combining chlorhexidine with alcohols or other bactericidal compounds.

• Sustainability efforts: Development of environmentally friendly formulations with biodegradable carriers and reduced volatile organic compounds (VOCs).

• Digital and smart applications: Integration with IoT for monitoring usage compliance in healthcare facilities.

Conclusion and Future Outlook

The landscape for Chlorhexidine Gluconate and Isopropyl Alcohol remains robust, with clinical trials underpinning expanded applications and improved formulations. Market growth is poised to benefit from ongoing public health initiatives, innovations in delivery systems, and expanding applications in dentistry, wound care, and environmental sanitation. However, manufacturers must navigate resistance issues, regulatory hurdles, and supply chain challenges.

Investments in R&D, strategic alliances, and adherence to safety standards will be pivotal in capturing opportunities within this dynamic segment.

Key Takeaways

• Recent clinical trials validate new delivery systems and expanded therapeutic applications for Chlorhexidine Gluconate, especially in infection prevention.

• Isopropyl Alcohol continues to be a staple in hand hygiene and surface disinfection, with ongoing optimization to enhance efficacy and skin tolerance.

• The disinfectants market exhibits steady growth, driven by heightened hygiene awareness, regulatory support, and innovation in formulation and packaging.

• Resistance development and supply chain issues represent significant challenges, necessitating strategic planning by industry players.

• Future industry growth hinges on eco-friendly, residual, and smart disinfectant solutions that address evolving safety and efficacy standards.

FAQs

Q1: How are new clinical trials influencing the use of chlorhexidine gluconate?
A1: These trials are facilitating the development of innovative formulations—such as slow-release patches and oral rinses—that enhance efficacy, expand indications, and improve patient compliance, thereby broadening chlorhexidine's clinical applications.

Q2: What innovations are emerging for isopropyl alcohol-based disinfectants?
A2: Innovations include residual formulations with extended antimicrobial activity, combination products with other disinfectants to address resistant microbes, and formulations optimized for skin tolerability and environmental sustainability.

Q3: How has the COVID-19 pandemic affected the market for these disinfectants?
A3: The pandemic significantly increased demand for hand sanitizers and surface disinfectants containing both agents, accelerating market growth, research, and product innovation, particularly in portable and bulk formulations.

Q4: What are the main regulatory considerations for chlorhexidine and isopropyl alcohol products?
A4: Regulatory agencies emphasize safety, efficacy, and environmental impact. Recent updates include restrictions on long-term use in neonatal settings for chlorhexidine and requirements for residual efficacy and non-toxicity in alcohol-based formulations.

Q5: What future market trends should industry stakeholders monitor?
A5: Stakeholders should observe developments in environmentally sustainable formulations, smart disinfection technology integration, expanding clinical applications, and evolving resistance patterns to maintain competitive advantage.

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References

1. [ClinicalTrials.gov - NCT04567890]
2. Market data derived from industry reports by MarketsandMarkets, 2023.