Tzanck Smear With Methylene Blue Stain for Herpes

What Was Tested

In this phase 3 trial, researchers set out to test Methylene blue (non-peptide stack partner).

To compare the sensitivity of Tzanck smear with methylene blue stain versus traditional Giemsa stain in patients with herpes infection.

It had two arms (groups): Case (active comparator) and Negative control (sham comparator).

Patients who clinically diagnosed as herpes simplex, herpes zoster or varicella zoster skin infection.

Patients who develops vesicular lesion but not typically considered as herpesviral skin infection, such as acute eczema, Paederus dermatitis.

The registry classes the interventions as diagnostic test.

More on the Plan

A smear from the lesional skin of the patients suspected having Herpes simplex, Herpes zoster and Varicella zoster skin infections will be collected (in a clinical routine setting).

The specimen will be stained with methylene blue in addition to the Giemsa stain.

Polymerase chain reaction study for herpes antigen will be performed in some of the specimens.

The sensitivity, specificity, positive predictive value and negative predictive value will be calculated from the results of the study.

Who Took Part

The registry lists 150 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Patients with clinically suspected of having herpes simplex, herpes zoster, varicella zoster skin infections. Those who have vesicular skin lesion such as acute eczema, Paederus dermatitis. Those are well cooperative. Age \> 18 years old.

The full record lists 4 inclusion and 1 exclusion criteria; among the exclusions: those who are not willing to have specimen from skin lesions to be collected.

How the Study Was Run

The set-up was non-randomized, parallel-group and quadruple-blind.

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

Neither the participants nor the staff measuring them knew who was on Methylene blue (non-peptide stack partner), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2017-03-07 with completion listed for 2017-12-07.

It ran at 1 site in Thailand.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Sensitivity (time frame: 24 weeks).

It also tracked 2 secondary outcomes, for example Factors that contribute the results from Methylene blue staining and Specificity.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Methylene blue (non-peptide stack partner) in 150 people.

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.