CLINICAL TRIALS PROFILE FOR POVIDONE IODINE

505(b)(2) Clinical Trials for Povidone Iodine

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	NCT01560962 ↗	Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis	Terminated	Southern California Institute for Research and Education	N/A	2012-01-01	Objective: To determine the preliminary outcome of external over the counter (OTC) povidone iodine (PI) application in the management of chronic and acute blepharitis vs. currently clinically accepted medical regimen, i.e. eyelid hygiene, antibiotic drops, or antibiotic/steroid ointments. Methodology: One hundred adult patients with chronic and acute blepharitis will be enrolled and randomized into four groups. In group one, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI twice daily for 10 days and the other eye with no intervention. In group two, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive warm soaked eyelid wash. In group three, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive 1 drop of azithromycin ophthalmic solution twice daily for 10 days. In group four, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive tobradex ointment applied to the lid margin. Subjective variables assessed included itchiness, foreign body sensation and eyelid edema (grade 0-4). Objective variables assessed included lid margin redness, meibomian gland plugging and presence/absence of collarets (grade 0-4). Cultures of lid margin at the initiation and at the cessation of treatment were obtained.

All Clinical Trials for Povidone Iodine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00136344 ↗	Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery	Completed	Santen Gmbh	N/A	2003-09-01	Cataract is the most important cause of visual impairment and decreased mobility in the elderly. While surgery is usually successful, it is also responsible for permanent loss of vision in up to 0.1% of patients due to severe post-operative infection (endophthalmitis). Because of this risk, surgery is typically performed on one eye at a time leaving the patient with a monocular cataract causing considerable visual impairment with reduction in mobility and quality of life. A second operation is required which often takes place up to one year later. It is not known at present whether the post-operative complication of endophthalmitis can be prevented by perioperative use of antibiotics. This randomised study (masked and placebo-controlled for topical levofloxacin and unmasked for intracameral injection of cefuroxime) sets out to test in 4 groups, each of 8,750 cataract surgery patients, if either topical antibiotic (levofloxacin) perioperatively or an intraocular (intracameral) injection of antibiotic (cefuroxime) at the end of phacoemulsification cataract surgery or the combination provides effective prophylaxis of post-operative infection (endophthalmitis) compared to controls in whom perioperative antibiotics are not used. The result will provide a scientific basis for prophylaxis of infection (endophthalmitis) following cataract surgery in Europe as well as an accurate figure for the incidence of endophthalmitis following phacoemulsification cataract surgery in Europe for the first time.
NCT00136344 ↗	Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery	Completed	The European Society of Cataract and Refractive Surgeons(ESCRS)	N/A	2003-09-01	Cataract is the most important cause of visual impairment and decreased mobility in the elderly. While surgery is usually successful, it is also responsible for permanent loss of vision in up to 0.1% of patients due to severe post-operative infection (endophthalmitis). Because of this risk, surgery is typically performed on one eye at a time leaving the patient with a monocular cataract causing considerable visual impairment with reduction in mobility and quality of life. A second operation is required which often takes place up to one year later. It is not known at present whether the post-operative complication of endophthalmitis can be prevented by perioperative use of antibiotics. This randomised study (masked and placebo-controlled for topical levofloxacin and unmasked for intracameral injection of cefuroxime) sets out to test in 4 groups, each of 8,750 cataract surgery patients, if either topical antibiotic (levofloxacin) perioperatively or an intraocular (intracameral) injection of antibiotic (cefuroxime) at the end of phacoemulsification cataract surgery or the combination provides effective prophylaxis of post-operative infection (endophthalmitis) compared to controls in whom perioperative antibiotics are not used. The result will provide a scientific basis for prophylaxis of infection (endophthalmitis) following cataract surgery in Europe as well as an accurate figure for the incidence of endophthalmitis following phacoemulsification cataract surgery in Europe for the first time.
NCT00136344 ↗	Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery	Completed	City, University of London	N/A	2003-09-01	Cataract is the most important cause of visual impairment and decreased mobility in the elderly. While surgery is usually successful, it is also responsible for permanent loss of vision in up to 0.1% of patients due to severe post-operative infection (endophthalmitis). Because of this risk, surgery is typically performed on one eye at a time leaving the patient with a monocular cataract causing considerable visual impairment with reduction in mobility and quality of life. A second operation is required which often takes place up to one year later. It is not known at present whether the post-operative complication of endophthalmitis can be prevented by perioperative use of antibiotics. This randomised study (masked and placebo-controlled for topical levofloxacin and unmasked for intracameral injection of cefuroxime) sets out to test in 4 groups, each of 8,750 cataract surgery patients, if either topical antibiotic (levofloxacin) perioperatively or an intraocular (intracameral) injection of antibiotic (cefuroxime) at the end of phacoemulsification cataract surgery or the combination provides effective prophylaxis of post-operative infection (endophthalmitis) compared to controls in whom perioperative antibiotics are not used. The result will provide a scientific basis for prophylaxis of infection (endophthalmitis) following cataract surgery in Europe as well as an accurate figure for the incidence of endophthalmitis following phacoemulsification cataract surgery in Europe for the first time.
NCT00223002 ↗	Chlorhexidine Versus Povidone-Iodine for Prevention of Epidural Needle Contamination in the Parturient	Completed	University of Saskatchewan	N/A	2004-11-01	Infection after epidural catheter placement is fortunately rare. When it does happen, the affected person can become seriously ill. This study examines which skin disinfectant, chlorhexidine or povidone-iodine, decreases the number of bacteria that can be grown from the skin washed with each disinfectant prior to placing an epidural catheter for pain control in labour.
NCT00231153 ↗	Study of Omiganan 1% Gel in Preventing Catheter Infections/Colonization in Patients With Central Venous Catheters	Completed	Cadence Pharmaceuticals	Phase 3	2005-08-01	The purpose of this study is to determine whether treatment with topical omiganan is more effective than treatment with topical povidone-iodine in preventing local catheter site infections and catheter colonization in patients who have central venous catheters.
NCT00231153 ↗	Study of Omiganan 1% Gel in Preventing Catheter Infections/Colonization in Patients With Central Venous Catheters	Completed	Mallinckrodt	Phase 3	2005-08-01	The purpose of this study is to determine whether treatment with topical omiganan is more effective than treatment with topical povidone-iodine in preventing local catheter site infections and catheter colonization in patients who have central venous catheters.

Clinical Trial Conditions for Povidone Iodine

Condition Name

Condition Name for Povidone Iodine
Intervention	Trials
Surgical Site Infection	17
COVID-19	11
Endophthalmitis	7
Covid19	6

Condition MeSH

Condition MeSH for Povidone Iodine
Intervention	Trials
Infections	37
Infection	30
Surgical Wound Infection	26
Communicable Diseases	24

Clinical Trial Locations for Povidone Iodine

Trials by Country

Trials by Country for Povidone Iodine
Location	Trials
United States	125
Egypt	23
France	12
Canada	10
Turkey	8

Trials by US State

Trials by US State for Povidone Iodine
Location	Trials
Illinois	9
Texas	8
New York	8
Missouri	8
Florida	8

Clinical Trial Progress for Povidone Iodine

Clinical Trial Phase

Clinical Trial Phase for Povidone Iodine
Clinical Trial Phase	Trials
Phase 4	57
Phase 3	29
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Povidone Iodine
Clinical Trial Phase	Trials
Completed	87
Recruiting	32
Unknown status	28

Clinical Trial Sponsors for Povidone Iodine

Sponsor Name

Sponsor Name for Povidone Iodine
Sponsor	Trials
Cairo University	6
Assiut University	6
Ain Shams University	6

Sponsor Type

Sponsor Type for Povidone Iodine
Sponsor	Trials
Other	266
Industry	24
U.S. Fed	9

Povidone Iodine: Clinical Trials, Market Analysis, and Projections

Introduction to Povidone Iodine

Povidone iodine (PVP-I) is a widely used antiseptic and disinfectant, known for its broad-spectrum antimicrobial properties. It has been employed in various medical and non-medical applications, including wound care, skin sterilization, and infection prevention.

Clinical Trials Update

COVID-19 and PVP-I Nasal Sprays

A notable clinical trial, identified by the trial ID NCT04347954, investigates the safety and efficacy of PVP-I containing nasal sprays compared to isotonic saline nasal sprays in COVID-19 positive patients. The primary outcome measure is the SARS-CoV-2 viral titers in the nasal cavity and nasopharynx. This study is significant because in vitro studies have shown PVP-I to be highly virucidal against viruses like SARS and MERS, and clinical studies have demonstrated its tolerance in human subjects[1].

Dental Caries Prevention

Another clinical trial, a Phase II randomized, double-blind, placebo-controlled study (NCT05272254), evaluates the efficacy of topical 10% PVP-I in preventing new cavitated caries lesions in children with Severe Early Childhood Caries (S-ECC). The study compares the application of 10% PVP-I plus fluoride varnish to a placebo plus fluoride varnish. The primary outcome is the time from randomization to the development of cavitated caries lesions, and secondary outcomes include the incidence and severity of dental caries and the diversity of oral microbiota[4].

Market Analysis

Global Market Size and Growth

The global povidone iodine market is projected to experience significant growth over the coming years. As of 2024, the market size was valued at approximately USD 167.41 million and is expected to reach USD 242.66 million by 2032, growing at a CAGR of 4.75% during the forecast period of 2025 to 2032[2].

Market Segmentation

The povidone iodine market is segmented by product type (electronic grade, pharmaceutical grade, industrial grade, medical grade), type (scrub, topical solution, ointments), concentration (10% solution, 7.5% solution), and application (infection prevention, skin sterilization, instrument sterilization, aquaculture, breeding industry, food industry, hospitals and clinics). The market also varies by end-users, including agrochemicals, electronics, paints and coatings, petrochemicals, and pharmaceuticals[2].

Key Drivers

The growth of the povidone iodine market is driven by several factors:

• Increasing Incidences of Injuries and Infections: The rising need for efficient disinfectants in various industries, especially in healthcare settings, is a major driver.
• COVID-19 Pandemic: The pandemic has heightened the importance of infection control, leading to increased demand for antiseptics like povidone iodine[5].
• Chronic Wounds: In regions like North America, the prevalence of chronic wounds, particularly among diabetic patients, is driving the demand for wound care treatments that include povidone iodine-based solutions[5].

Opportunities and Investments

Significant investments in research and development are enhancing the applications of povidone iodine. Companies are conducting in vitro and in vivo studies to evaluate the efficacy of PVP-I against various pathogens, including the novel coronavirus. Product developments, such as the use of povidone iodine in antiseptic cream formulations and presurgical vaginal irrigation, are also expanding market opportunities[3].

Market Projections

Forecast Period

The povidone iodine market is expected to grow at a CAGR of around 4-5% over the next several years. By 2032, the market is projected to reach a valuation of USD 242.66 million, up from USD 167.41 million in 2024[2].

Regional Growth

North America, particularly the United States, is anticipated to exhibit substantial growth due to the increasing prevalence of chronic wounds and the growing emphasis on preventive healthcare measures. The rising awareness of infection control and the necessity of efficient disinfectants in various industries are also contributing to the market's growth in this region[5].

Challenges and Restraints

Despite the positive outlook, the povidone iodine market faces some challenges:

• Side Effects: Common side effects such as local swelling, irritation, itching, and rash can limit the market growth. Excessive use of povidone iodine can also be corrosive[2].
• Allergies and Sensitivities: Allergies to iodine, shellfish, or certain food dyes can exclude some individuals from using povidone iodine products, which may impact market penetration[1][4].

Key Applications and Uses

Infection Prevention and Skin Sterilization

Povidone iodine is widely used for infection prevention and skin sterilization, especially in healthcare settings. Its effectiveness in reducing the number of microorganisms on the skin makes it a crucial component in pre-surgical preparations and wound care[3].

Wound Healing and Treatment

The market is also driven by the increasing use of povidone iodine in wound healing and treatment. Manufacturers are developing topical drug formulations that include povidone iodine for efficient wound care and infection treatment[3].

Dental Care

In the dental sector, povidone iodine is being evaluated for its efficacy in preventing dental caries and reducing the incidence of oral infections. The ongoing clinical trial on its use in children with Severe Early Childhood Caries highlights its potential in this area[4].

Conclusion

Povidone iodine remains a vital antiseptic and disinfectant with a broad range of applications. The ongoing clinical trials and market projections indicate a strong future for this compound, driven by its efficacy against various pathogens and its increasing use in healthcare and other industries.

Key Takeaways

• Clinical Trials: Ongoing trials are evaluating the efficacy of povidone iodine against COVID-19 and in dental care.
• Market Growth: The global povidone iodine market is projected to grow at a CAGR of 4-5% over the next several years.
• Key Drivers: Increasing incidences of infections, the COVID-19 pandemic, and the prevalence of chronic wounds are driving market growth.
• Challenges: Side effects and allergies are potential restraints on the market.
• Applications: Povidone iodine is used in infection prevention, skin sterilization, wound healing, and dental care.

FAQs

What is the primary use of povidone iodine in clinical settings?

Povidone iodine is primarily used as an antiseptic and disinfectant for infection prevention, skin sterilization, and wound care.

What are the common side effects of povidone iodine?

Common side effects include local swelling, irritation, itching, and rash. Excessive use can also be corrosive.

How is povidone iodine being used in the context of COVID-19?

Clinical trials are investigating the efficacy of povidone iodine nasal sprays in reducing SARS-CoV-2 viral titers in the nasal cavity and nasopharynx.

What is the projected market size of povidone iodine by 2032?

The global povidone iodine market is projected to reach USD 242.66 million by 2032.

What are the main drivers of the povidone iodine market in North America?

The main drivers include the increasing prevalence of chronic wounds, particularly among diabetic patients, and the growing emphasis on preventive healthcare measures.

Sources

1. Stanford Medicine: PVP-I Nasal Sprays and SARS-CoV-2 Nasopharyngeal Titers (for COVID-19)[1].
2. Data Bridge Market Research: Global Povidone Iodine Market Size, Share, and Trends Analysis[2].
3. Transparency Market Research: Povidone Iodine Market | Global Industry Report, 2030[3].
4. CenterWatch: Povidone Iodine Efficacy Study | Clinical Research Trial Listing[4].
5. Verified Market Research: Povidone Iodine Market Size, Share, Trends, Scope & Forecast[5].