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Last Updated: March 20, 2025

CLINICAL TRIALS PROFILE FOR POVIDONE-IODINE


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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
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Condition MeSH

Condition MeSH for Povidone-iodine
Intervention Trials
Infections 37
Infection 30
Surgical Wound Infection 26
Communicable Diseases 24
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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
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Trials by US State

Trials by US State for Povidone-iodine
Location Trials
Illinois 9
New York 8
Missouri 8
Florida 8
Texas 8
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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
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Clinical Trial Status

Clinical Trial Status for Povidone-iodine
Clinical Trial Phase Trials
Completed 87
Recruiting 32
Unknown status 28
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Clinical Trial Sponsors for Povidone-iodine

Sponsor Name

Sponsor Name for Povidone-iodine
Sponsor Trials
Cairo University 6
Ain Shams University 6
Assiut University 6
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Sponsor Type

Sponsor Type for Povidone-iodine
Sponsor Trials
Other 266
Industry 24
U.S. Fed 9
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Povidone-Iodine: Clinical Trials, Market Analysis, and Projections

Introduction to Povidone-Iodine

Povidone-iodine (PVP-I), commonly known by the brand name Betadine, is a widely used antiseptic and disinfectant. It has been a staple in medical and household settings for its effective bactericidal, virucidal, and fungicidal properties. Here, we will delve into recent clinical trials, market analysis, and future projections for povidone-iodine.

Clinical Trials and Efficacy

Reducing Nasopharyngeal Viral Load

A recent randomized clinical trial published in the Journal of the American Medical Association Otolaryngology - Head & Neck Surgery investigated the efficacy of povidone-iodine in reducing the nasopharyngeal viral load of patients with COVID-19. The study involved patients undergoing successive mouthwashes, gargles, and nasal sprays with a 1% aqueous povidone-iodine solution. While the study showed a significant reduction in viral titers in the intervention group compared to the control group, it did not conclusively prove that povidone-iodine reduced the viral load in a way that would prevent transmission. However, it suggested that nasopharyngeal decolonization with povidone-iodine could be beneficial in reducing the carriage of infectious SARS-CoV-2[1].

Nasal Decolonization

Another study focused on the effect of nasal decolonization using povidone-iodine. This prospective study involved 50 individuals who received either a nasal antiseptic solution containing povidone-iodine or a control PBS solution. The results showed a significant reduction in bioburden after the application of povidone-iodine, highlighting its potential in reducing nasal microbiota and preventing infections[4].

Market Analysis

Current Market Size and Growth

The global povidone-iodine market has seen significant growth, driven by increasing awareness of infection control and the need for efficient disinfectants. As of 2024, the market size was valued at approximately USD 145.06 million and is projected to reach USD 204.57 million by 2031, growing at a CAGR of 4.39%[5].

Market Segmentation

The povidone-iodine market is segmented by product type, concentration, application, and end-users. Key segments include:

  • Product Type: Electronic grade, pharmaceutical grade, industrial grade, and medical grade.
  • Type: Scrubs, topical solutions, and ointments.
  • Concentration: 10% solution, 7.5% solution, among others.
  • Application: Infection prevention, skin sterilization, instrument sterilization, and various industrial uses.
  • End-Users: Agrochemicals, electronics, paints and coatings, petrochemicals, pharmaceuticals, and others[2][3].

Regional Analysis

The market is analyzed across various regions including North America, Europe, Asia-Pacific, Middle East and Africa, and South America. The Asia-Pacific region is expected to see significant growth due to increasing healthcare needs and industrial applications[2][3].

Market Projections

Growth Drivers

Several factors are driving the growth of the povidone-iodine market:

  • Increasing Incidences of Infections: The need for effective antiseptics in healthcare settings, especially during the COVID-19 pandemic, has boosted demand.
  • R&D and Product Developments: Significant investments in research and development are expanding the applications of povidone-iodine, including its use in wound healing and surgical site infection prevention[2][3][5].

Challenges and Restraints

Despite the growth, the market faces some challenges:

  • Side Effects: Local swelling, irritation, itching, and rash are common side effects of povidone-iodine, which can limit its use.
  • Corrosive Nature: Excessive use of povidone-iodine can be corrosive, necessitating careful application[2].

Future Outlook

Expanding Applications

Povidone-iodine is expected to see increased use in various applications, including:

  • Skin Sterilization: Its effectiveness in reducing microorganisms on the skin makes it a crucial component in skin sterilization products.
  • Wound Healing: The development of povidone-iodine liposome hydrogel for topical wound treatment is a promising area of growth.
  • Preventive Healthcare: Its use in presurgical vaginal irrigation and in preventing postoperative wound infections will continue to drive demand[3].

Market Valuation

By 2032, the global povidone-iodine market is projected to reach a valuation of USD 242.66 million, growing at a CAGR of 4.75% from 2025 to 2032. Another estimate suggests the market could reach a valuation of USD 256.7 billion by 2030, with a CAGR of around 5% from 2020 to 2030[2][3].

Key Takeaways

  • Clinical Efficacy: Povidone-iodine has shown promise in reducing nasopharyngeal viral load and nasal bioburden, although larger clinical trials are needed to confirm its benefits.
  • Market Growth: The market is driven by increasing demand for infection control measures and expanding applications in healthcare and industrial sectors.
  • Challenges: Side effects and the corrosive nature of povidone-iodine are significant challenges that need to be addressed.
  • Future Outlook: The market is expected to grow significantly, with a focus on skin sterilization, wound healing, and preventive healthcare.

FAQs

Q: What are the primary applications of povidone-iodine?

A: Povidone-iodine is primarily used for infection prevention, skin sterilization, instrument sterilization, and in various industrial applications.

Q: How effective is povidone-iodine against COVID-19?

A: Clinical trials suggest that povidone-iodine can reduce nasopharyngeal viral load and nasal bioburden, but larger studies are needed to confirm its efficacy in preventing transmission.

Q: What are the common side effects of povidone-iodine?

A: Common side effects include local swelling, irritation, itching, and rash. It can also be corrosive if used excessively.

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

A: The global povidone-iodine market is projected to reach a valuation of USD 242.66 million by 2032, growing at a CAGR of 4.75% from 2025 to 2032.

Q: Which regions are expected to see significant growth in the povidone-iodine market?

A: The Asia-Pacific region is expected to see significant growth due to increasing healthcare needs and industrial applications.

Sources

  1. Guenezan J, Garcia M, Strasters D, et al. Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Nasopharyngeal Viral Load in Patients With COVID-19: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021;147(4):400–401. doi:10.1001/jamaoto.2020.5490
  2. Global Povidone Iodine Market Size, Share, and Trends Analysis. Data Bridge Market Research.
  3. Povidone Iodine Market | Global Industry Report, 2030. Transparency Market Research.
  4. Nasal Microbiome and the Effect of Nasal Decolonization with a Povidone-Iodine Solution. Oxford Academic.
  5. Povidone Iodine Market Size, Share, Trends, Scope & Forecast. Verified Market Research.

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