Red Light Photobiomodulation and Topical Disinfectants

NCT ID: NCT05797818

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2023-02-08

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.

Conditions

Healthcare Associated Infection; Nosocomial Infection; Surgical Site Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Methylene Blue Only

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Chlorhexidine Gluconate Only

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Methylene Blue + Chlorhexidine Gluconate

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Light Only

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ondine Biomedical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ROGER ANDERSEN, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Ondine Biomedical

Locations

Ondine Research Laboratories

Bothell, Washington, United States

Countries

United States

Other Identifiers

31686-2022

Identifier Type: -

Identifier Source: org_study_id