Red Light Photobiomodulation and Topical Disinfectants

The Effect of Red Light Photobiomodulation and Topical Disinfectants on the Nasal Microbiome

The goal of this clinical trial is to evaluate the potential effects of photobiomodulation when used with topical disinfectants in the anterior nares of healthy adults.

Over a three week period, participants will have their anterior nares swabbed with methylene blue, chlorhexidine gluconate, or a combination of the two followed by 4 minutes of non-thermal red light treatment. The fourth week of consist of only red light treatment. Culture samples of the subjects nasal microbiome will be taken prior to treatment, immediately after treatment, 4-, 8-, 24-, and 48 hours after treatment.

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection; Nosocomial Infection; Healthcare Associated Infection
• Intervention / Treatment: Device: Methylene Blue Only; Device: Chlorhexidine Gluconate Only; Device: Methylene Blue + Chlorhexidine Gluconate; Device: Light Only

Detailed Description

This is an exploratory, single-center, open-label, single-arm study with microbiological endpoint using photobiomodulation (PBM) and topical disinfectants to determine the effect on the nasal microbiota.

The photobiomodulation system distributes about 700mW of light to each nostril using a 2-channel diode laser with non-thermal, red light. The topical disinfectants are methylene blue (0.01%) and chlorhexidine gluconate (0.25%). Following a pretreatment nasal culture, these two disinfectants will be administered into the patient's anterior nares followed by a two-minute light cycle. This process is repeated once more resulting in two treatments cycles (4-minutes total). Following this, nasal cultures are taken immediately and at 4-, 8-, 24-, and 48- hours. Broad spectrum and Staphylococcus spp. culturing of nasal swabs will be conducted. Swabs will also be submitted for Next Generation Sequencing to characterize the effect of light and disinfectants on the nasal microbiome.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Washington
    • Bothell, Washington, United States, 98011
      • Ondine Research Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must be 18 years of age or older

Exclusion Criteria:

• Pregnant Women
• Those Under 18 years of age
• Prisoners
• Mentally Disabled Persons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Methylene Blue; All subjects will have an initial baseline culture done of their nasal microbiome followed by an administration of 0.01% methylene blue solution. Next, subjects will undergo two minute of non-thermal red light exposure. A second round of solution administration and light exposure will be repeated resulting in 4 minutes of red light exposure. Once the treatment has been completed, a new culture will be taken from the subjects nares followed by one at 4-, 8-, 24-, and 48-hours after treatment.	Device: Methylene Blue Only; All subjects will have a baseline sample taken of their nasal microbiome and undergo the administration of the following: - Methylene Blue (0.01%) + 4 minutes of light treatment
Experimental: Chlorhexidine gluconate; All subjects will have an initial baseline culture done of their nasal microbiome followed by an administration of 0.25% chlorhexidine solution. Next, subjects will undergo two minute of non-thermal red light exposure. A second round of solution administration and light exposure will be repeated resulting in 4 minutes of red light exposure. Once the treatment has been completed, a new culture will be taken from the subjects nares followed by one at 4-, 8-, 24-, and 48-hours after treatment.	Device: Chlorhexidine Gluconate Only; All subjects will have a baseline sample taken of their nasal microbiome and undergo the administration of the following: - Chlorhexidine gluconate (0.25%) + 4 minutes of light treatment
Experimental: Methylene blue and Chlorhexidine gluconate; All subjects will have an initial baseline culture done of their nasal microbiome followed by an administration of 0.01% methylene blue and 0.25% chlorhexidine gluconate solution. Next, subjects will undergo two minute of non-thermal red light exposure. A second round of solution administration and light exposure will be repeated resulting in 4 minutes of red light exposure. Once the treatment has been completed, a new culture will be taken from the subjects nares followed by one at 4-, 8-, 24-, and 48-hours after treatment.	Device: Methylene Blue + Chlorhexidine Gluconate; All subjects will have a baseline sample taken of their nasal microbiome and undergo the administration of the following: - Methylene blue (0.01%) + chlorhexidine gluconate (0.25%) + 4 minutes of light treatment
Experimental: Light Only; All subjects will have an initial baseline culture done of their nasal microbiome followed by 4 minutes of non-thermal red light exposure. Once the treatment has been completed, a new culture will be taken from the subjects nares followed by one at 4-, 8-, 24-, and 48-hours after treatment.	Device: Light Only; All subjects will have a baseline sample taken of their nasal microbiome and undergo the administration of the following: - 4 minutes of light treatment only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of PBM with Topical Disinfectants (Quantitative)	The Quantitative outcome measure is the change from baseline in nasal bacterial bioburden (measured in CFU/mL) by the effects of red light photobiomodulation on nasal bacteria when used with and without topical disinfectants. Each subject's baseline nasal bacterial level is determined prior to the weekly intervention. There are no subject reported outcome measures.	The change in bacterial bioburden during the week of each of the four weeks respective intervention.
Effect of PBM with Topical Disinfectants (Semi-Quantitative)	The Semi-quantitative outcome measure is the change in bacterial growth between different time points measured by the number of quadrants with bacterial growth on a culture plate. Photographs of each culture plate will allow visual comparisons between time points. Each subject's baseline nasal bacterial level is determined prior to the weekly intervention.	The change in bacterial bioburden during the week of each of the four weeks respective intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of PBM with Topical Disinfectants (NGS)	Nasal culture responses over several days will be evaluated using Next Generation Sequencing (NGS) to determine how long it takes for the nasal microbiome to return to its previous non-treated level. NGS allows for determining what percentage of the total microbiome a certain species of bacteria is.	The change in bacterial bioburden during the week of each of the four weeks respective intervention.

Collaborators and Investigators

• Sponsor: Ondine Biomedical Inc.
• Investigators: Principal Investigator: ROGER ANDERSEN, MD, MPH, Ondine Biomedical

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Actual): February 8, 2023
• Study Completion (Actual): February 8, 2023

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Methylene blue; Photodynamic therapy; Photobiomodulation; Chlorhexidine gluconate; Nasal decolonization; Staphylococcal aureus; Nasal microbiome
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Iatrogenic Disease; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection; Cross Infection; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Dermatologic Agents; Disinfectants; Chlorhexidine; Methylene Blue; Chlorhexidine gluconate
• Other Study ID Numbers: 31686-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes