Red Light Photobiomodulation and Topical Disinfectants

NCT05797818 | Completed Phase 1 FDA Device

• 1 other identifier: 31686-2022
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthcare Associated Infection; Nosocomial Infection; Surgical Site Infection

Keywords

Staphylococcal aureus; Methylene blue; Chlorhexidine gluconate; Nasal decolonization; Photobiomodulation; Photodynamic therapy; Nasal microbiome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Effect of PBM with Topical Disinfectants (NGS)

  The change in bacterial bioburden during the week of each of the four weeks respective intervention.

Study Arms (4)

Methylene Blue

EXPERIMENTAL

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

Chlorhexidine gluconate

EXPERIMENTAL

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

Methylene blue and Chlorhexidine gluconate

EXPERIMENTAL

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

Light Only

EXPERIMENTAL

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

Interventions

Methylene Blue Only DEVICE

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

Methylene Blue

Chlorhexidine Gluconate Only DEVICE

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

Chlorhexidine gluconate

Methylene Blue + Chlorhexidine Gluconate DEVICE

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

Methylene blue and Chlorhexidine gluconate

Light Only DEVICE

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

Light Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be 18 years of age or older

You may not qualify if:

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

Sponsors & Collaborators

• Ondine Biomedical Inc.: lead

Study Sites (1)

Ondine Research Laboratories

Bothell, Washington, 98011, United States

Location

MeSH Terms

Conditions

Cross Infection; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wound Infection; Postoperative Complications

Study Officials

• ROGER ANDERSEN, MD, MPH

  Ondine Biomedical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single open-label healthy group is being evaluated for any changes to the normal nasal microbiome. Each week nasal cultures will be done and the subject exposed to different interventions including red light alone, and several disinfectants. Nasal cultures will be done for 48 hours after the intervention to determine the effect, if any, on the nasal microbiome.

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: April 4, 2023
• Study Start: January 10, 2023
• Primary Completion: February 8, 2023
• Study Completion: February 8, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)