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Hidradenitis Suppurativa Wound Care

Plain-language guide to NCT04354012: phase 2 interventional trial of Methylene blue (non-peptide stack partner), 5 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04354012
Phase
phase 2
Status
completed
Start
2021-02-04
Completion (planned or actual)
2024-08-28
Participants
5 (actual)
Design
na, open label (everyone knows who gets what), treatment
Conditions studied
Hidradenitis Suppurativa (HS)
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

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

It had 1 arm (groups): Treatment (experimental).

The registry classes the interventions as combination product.

More on the Plan

Hidradenitis suppurativa (HS) is a chronic and debilitating inflammatory disease most frequently affecting the axilla, groin, and inframammary regions.

Symptoms include nodules, abscesses, sinus tract formation, malodorous drainage, and scarring.

These symptoms interfere with everyday activities, which can lead to social embarrassment and isolation.

Patients suffer with the burden of at home wound care for recurrent, draining nodules.

Who Took Part

Enrollment: 5 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Individuals with hidradenitis suppurativa with non-healing wounds or draining abscesses/nodules. Individuals over 18 years of age.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: individuals younger than 18 years of age; individuals without a diagnosis of hs.

How the Study Was Run

It was run as a 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 2021-02-04 with completion listed for 2024-08-28.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent Change in Wound Size (time frame: Measure from Baseline to week 8).

It also tracked 4 secondary outcomes, for example Change in Pain Assessment Scores, Change in Pain Assessment Scores, Change in Pain Assessment Scores and Change in Pain Assessment Scores.

What This Means in Plain Language

Put simply, this is a phase 2 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.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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.

Related Pages

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.