Tzanck Smear With Methylene Blue Stain for Herpes

A Comparative Study of Tzanck Smear With Methylene Blue Versus Giemsa Stain to Diagnose Herpes Simplex, Herpes Zoster and Varicella Zoster Skin Infections

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03178747

Enrollment

150

Registered

2017-06-07

Start date

2017-03-07

Completion date

2018-03-06

Last updated

2017-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Simplex, Herpes Zoster, Varicella Zoster

Keywords

Methylene blue, Giemsa, Tzanck smear

Brief summary

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

Detailed description

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.

Interventions

DIAGNOSTIC_TESTMethylene blue

working solution methylene blue

DIAGNOSTIC_TESTGiemsa stain

working solution Giemsa stain (Wolbach's modification)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* Those who are not willing to have specimen from skin lesions to be collected.

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity	24 weeks	Positive results from staining compared with number of cases

Secondary

Measure	Time frame	Description
Factors that contribute the results from Methylene blue staining	24 weeks	Subgroup analysis which included age, sex, clinical morphology, distribution, duration of lesion.
Specificity	24 weeks	—

Countries

Thailand

Contacts

Primary ContactPawinee Rerknimitr, MD, MSc

pawinee.r@chula.ac.th+6622564253

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026