CClinicalTrials.gg
Status unknownNCT03178747Updated Aug 4, 2017

Tzanck Smear With Methylene Blue Stain for Herpes

A Phase 3 interventional study of Methylene blue and Giemsa stain in Herpes Simplex, Herpes Zoster and Varicella Zoster, sponsored by Chulalongkorn University. Status unknown at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-04.

Sponsored by Chulalongkorn University · Phase 3, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Herpes Simplex
  • Herpes Zoster
  • Varicella Zoster

Keywords

  • Methylene blue
  • Giemsa
  • Tzanck smear
03

In context

Herpes Simplex

305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.

This study's planned enrollment of 150 is above the median of 101 across 227 interventional studies indexed under Herpes Simplex.

Browse Herpes Simplex studies →

Lead sponsor

Chulalongkorn University is the lead sponsor of 312 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Those who are not willing to have specimen from skin lesions to be collected.
05

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    Case

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

    Diagnostic Test: Methylene blue · Diagnostic Test: Giemsa stain

  • Sham comparator
    Negative control

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

    Diagnostic Test: Methylene blue · Diagnostic Test: Giemsa stain

Interventions

  • Diagnostic testMethylene blue

    working solution methylene blue

  • Diagnostic testGiemsa stain

    working solution Giemsa stain (Wolbach's modification)

06

What researchers measure

Primary outcomes

  1. Sensitivity

    Positive results from staining compared with number of cases

    Time frame: 24 weeks

Secondary outcomes

  1. Factors that contribute the results from Methylene blue staining

    Subgroup analysis which included age, sex, clinical morphology, distribution, duration of lesion.

    Time frame: 24 weeks

  2. Specificity

    Time frame: 24 weeks

07

Study locations

1 of 1 sites recruiting
  • Division of Dermatology, Faculty of Medicine, Chulalongkorn University
    Bangkok, 10330, Thailand
    • Pawinee Rerknimitr, MD, MSc · Contact · pawinee.r@chula.ac.th · +6622564253
    • Kittipong Wantavornprasert, MD · Sub investigator
    • Pokrath Hansasuta, MD, PhD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03178747
Lead sponsor
Chulalongkorn University
Collaborators
Dermatological Society of Thailand
Responsible party
Pawinee Rerknimitr (Assistant professor, Chulalongkorn University) — Principal investigator
First posted
Jun 7, 2017
Start date
Mar 7, 2017
Primary completion
Dec 7, 2017 (estimated)
Completion
Mar 6, 2018 (estimated)
Last update
Aug 4, 2017

Study contacts

Pawinee Rerknimitr, MD, MSc
Contact
pawinee.r@chula.ac.th
+6622564253
Pawinee Rerknimitr, MD, MSc
principal investigator · Chulalongkorn University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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