NCT05797818

Red Light Photobiomodulation and Topical Disinfectants

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Ondine Biomedical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-01-10
• Primary completion: 2023-02-08
• Completion: 2023-02-08
• First posted: 2023-04-04
• Last updated: 2023-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study