Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis

Plain-language guide to NCT07012343: not phased randomized trial of Methylene blue (non-peptide stack partner), 50 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT07012343
Phase: not phased
Status: active, not recruiting
Start: 2025-01-13
Completion (planned or actual): 2026-06-30
Participants: 50 (actual)
Design: randomized, double-blind, treatment
Conditions studied: Onychomycosis of Toenails; Onychomycosis of Fingernail
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).

It had five arms (groups): PDT_160OIW (experimental), PDT_160BIW (experimental), PDT_120BIW (experimental), PDT_80BIW (experimental) and NonPDT (placebo comparator).

The registry classes the interventions as drug and radiation.

Who Took Part

The registry lists 50 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Patients diagnosed with onychomycosis (nail fungal infection) by a dermatologist. Diagnosis criteria include at least one clinical criterion combined with at least one laboratory examination criterion. Discoloration patches/streaks on the nail. Onycholysis (nail separation from the nail bed). Subungual hyperkeratosis/debris (thickening under the nail).

The full record lists 12 inclusion and 10 exclusion criteria; among the exclusions: presence of nail abnormalities caused by other diseases or conditions; pregnant or breastfeeding; history of receiving oral antifungal agents within the past 6 months or topical antifungal agents within the past 1 month prior to enrollment.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Methylene blue (non-peptide stack partner) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Methylene blue (non-peptide stack partner).

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2025-01-13 with completion listed for 2026-06-30.

It ran at 1 site in Thailand.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 50 people.

Its status is active not recruiting; 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.