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NCT Number: NCT05797818

Red Light Photobiomodulation and Topical Disinfectants

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.

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Key information

Conditions

Healthcare Associated Infection Cross Infection Disease Attributes Iatrogenic Disease Infections Nosocomial Infection Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Site Infection Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Ondine Research Laboratories

Bothell, Washington, 98011, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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

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

Primary outcomes

  1. Effect of PBM with Topical Disinfectants (Quantitative)

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

    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.

  2. Effect of PBM with Topical Disinfectants (Semi-Quantitative)

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

    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 outcomes

  1. Effect of PBM with Topical Disinfectants (NGS)

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

    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.

Sponsors and collaborators

Lead sponsor

Ondine Biomedical Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 4, 2023
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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