Red Light Photobiomodulation and Topical Disinfectants

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Methylene blue (non-peptide stack partner).

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.

It had four arms (groups): Methylene Blue (experimental), Chlorhexidine gluconate (experimental), Methylene blue and Chlorhexidine gluconate (experimental) and Light Only (experimental).

The registry classes the interventions as device.

More on the Plan

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.

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).

Who Took Part

Enrollment: 28 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Subjects must be 18 years of age or older.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: pregnant women; those under 18 years of age; mentally disabled persons.

How the Study Was Run

Design: non-randomized, sequential and open-label.

Nothing was hidden in this open-label Methylene blue (non-peptide stack partner) study: the participants and staff both knew the treatment.

It started in 2023-01-10 with completion listed for 2023-02-08.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: 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). 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).

It also tracked 1 secondary outcome, for example Effect of PBM with Topical Disinfectants (NGS).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, non-randomized trial of Methylene blue (non-peptide stack partner) in 28 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.