Red Light Photobiomodulation and Topical Disinfectants

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Methylene Blue Only

Chlorhexidine Gluconate Only

Methylene Blue + Chlorhexidine Gluconate

Light Only

About this trial

This is an interventional basic science trial for Healthcare Associated Infection focused on measuring Staphylococcal aureus, Methylene blue, Chlorhexidine gluconate, Nasal decolonization, Photobiomodulation, Photodynamic therapy, Nasal microbiome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Ondine Research Laboratories

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Methylene Blue

Chlorhexidine gluconate

Methylene blue and Chlorhexidine gluconate

Light Only

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05797818

First Posted

January 26, 2023

Last Updated

March 21, 2023

Sponsor

Ondine Biomedical Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05797818

Brief Title

Red Light Photobiomodulation and Topical Disinfectants

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

January 10, 2023 (Actual)

Primary Completion Date

February 8, 2023 (Actual)

Study Completion Date

February 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ondine Biomedical Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

No

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthcare Associated Infection, Nosocomial Infection, Surgical Site Infection

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Methylene Blue

Arm Type

Experimental

Arm Description

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.

Arm Title

Chlorhexidine gluconate

Arm Type

Experimental

Arm Description

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.

Arm Title

Methylene blue and Chlorhexidine gluconate

Arm Type

Experimental

Arm Description

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.

Arm Title

Light Only

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Methylene Blue Only

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Chlorhexidine Gluconate Only

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Methylene Blue + Chlorhexidine Gluconate

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Light Only

Intervention Description

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

Primary Outcome Measure Information:

Title

Effect of PBM with Topical Disinfectants (Quantitative)

Description

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.

Time Frame

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

Title

Effect of PBM with Topical Disinfectants (Semi-Quantitative)

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Effect of PBM with Topical Disinfectants (NGS)

Description

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.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ROGER ANDERSEN, MD, MPH

Organizational Affiliation

Ondine Biomedical

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ondine Research Laboratories

City

Bothell

State/Province

Washington

ZIP/Postal Code

98011

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

Healthcare Associated Infection, Nosocomial Infection, Surgical Site Infection

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial