Methylene Blue Intra-vital Nerve Staining

Plain-language guide to NCT05547685: not phased interventional trial of Methylene blue (non-peptide stack partner), 5 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT05547685
Phase: not phased
Status: status unknown
Start: 2020-04-10
Completion (planned or actual): 2022-10-17
Participants: 5 (estimated)
Design: na, open label (everyone knows who gets what), diagnostic
Conditions studied: Neurologic Findings
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Methylene blue (non-peptide stack partner).

In previous studies, the researchers know methylene blue (MB) stains nerves, and oxidized MB has near-infrared (NIR) fluorescence for fluorescent observation.

In this trial the researchers using MB on human skin and combining MB and third-harmonic generation imaging (THG) to label cutaneous nerve fibers.

It had 1 arm (groups): Methylene blue intradermal injection (experimental).

Methylene blue intradermal injection.

The registry classes the interventions as diagnostic test.

More on the Plan

The participant lay down and the skin was imaged 10 cm above the ankle in the lower leg and above the wrist in the middle forearm; three sites in each limb were randomly selected for each time point.

Who Took Part

Enrollment: 5 planned participants were the target.

It was open to people of any sex aged from 20 years up to 70 years.

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

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: used serotonin agonist medication.

How the Study Was Run

The set-up was single-group 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.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2020-04-10 with completion listed for 2022-10-17.

It ran at 1 site in Taiwan.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: intravital staining (time frame: 12 months).

What This Means in Plain Language

Put simply, this is a not phased trial of Methylene blue (non-peptide stack partner) in 5 people.

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

Its status is unknown; 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.

Our Notes on the Compound

Methylene blue (non-peptide stack partner): Described as an electron cycler, not just a dye.

Methylene blue (non-peptide stack partner) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.