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Red Light Photobiomodulation and Topical Disinfectants

NCT05797818 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-04-04

No results posted yet for this study

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

Interventions

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

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

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

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

Sponsors & Collaborators

  • Ondine Biomedical Inc.

    lead INDUSTRY

Principal Investigators

  • ROGER ANDERSEN, MD, MPH · Ondine Biomedical

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2023-02-08
Completion
2023-02-08
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05797818 on ClinicalTrials.gov