Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment

What Was Tested

The trial (not phased) is built around Methylene blue (non-peptide stack partner).

It had two arms (groups): MB-PDT for Onychomycosis (experimental) and Amorolfine for Onychomycosis (active comparator).

The registry classes the interventions as drug and procedure.

More on the Plan

Those with nail changes because of skin disease or associated systemic diseases 2.

Those who had previously used anti-fungal medications within 3 months for systemic and 1 month for topical therapy. * Methods 1.

Patients will be informed of the details of the study including predicted possible adverse events due to the treatments and primary aids. 2.

Who Took Part

27 actual participants took part.

It was open to people of any sex aged from 18 years up to 90 years.

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

Examples of who could join: Patients, aged between 18-90 years old, with distal and lateral subungual toenail onychomycosis diagnosed clinically and mycologically. Clinical signs of onychomycosis as following:. Dystrophy of nail plate. Positive culture of dermatophyte or non-dermatophyte (must be isolated from sequential specimens) and/or. Positive microscopic evidence\*.

The full record lists 10 inclusion and 5 exclusion criteria; among the exclusions: those with nail changes because of skin disease or associated systemic diseases; pregnancy or lactating woman; those who are allergic to amorolfine, methylene blue.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Because people in this Methylene blue (non-peptide stack partner) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Methylene blue (non-peptide stack partner) group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Methylene blue (non-peptide stack partner) was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2017-06-01 with completion listed for 2018-12-30.

It ran at 1 site in Thailand.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Onychomycosis severity index (OSI).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 27 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.