PhotoDynamic Therapy for Line Infection Prevention (PLIP): Pilot Study on Healthy Volunteers.

Plain-language guide to NCT01981460: not phased non-randomized trial of Methylene blue (non-peptide stack partner), 10 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01981460
Phase: not phased
Status: completed
Start: 2013-05
Completion (planned or actual): 2013-06
Participants: 10 (actual)
Design: non-randomized, open label (everyone knows who gets what), treatment
Conditions studied: Light; Therapy, Complications
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).

The researchers are evaluating the effect of methylene blue and visible light activation on the microbiome of the skin.

It had two arms (groups): Chloroprep and biopatch (no intervention) and Methylene blue and light treatment (experimental).

Both arms are cleaned with chloroprep and a biopatch is placed on each arm.

Methylene blue and light treatment for 17 minutes are done twice over 1 week intervals.

The registry classes the interventions as procedure.

More on the Plan

This is a pilot study of normal volunteers to determine the effect on the microbiome of the addition of methylene blue and light activation on antiseptic-treated skin.

Who Took Part

The registry lists 10 actual participants took part.

It was open to people of any sex aged from 21 years up to 60 years.

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

Examples of who could join: Normal individuals without skin problems.

The full record lists 1 inclusion and 7 exclusion criteria; among the exclusions: atopic dermatitis; G-6-PD deficiency; other skin conditions.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

Everyone knew when Methylene blue (non-peptide stack partner) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2013-05 with completion listed for 2013-06.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Evaluation of the skin microbiome after methylene blue treatment (time frame: 1 week).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Methylene blue (non-peptide stack partner) in 10 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.

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.