Tzanck Smear With Methylene Blue Stain for Herpes

August 3, 2017 updated by: Pawinee Rerknimitr, Chulalongkorn University

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

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

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Bangkok, Thailand, 10330
        • Recruiting
        • Division of Dermatology, Faculty of Medicine, Chulalongkorn University
        • Contact:
        • Sub-Investigator:
          • Kittipong Wantavornprasert, MD
        • Sub-Investigator:
          • Pokrath Hansasuta, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Case
Patients who clinically diagnosed as herpes simplex, herpes zoster or varicella zoster skin infection.
working solution methylene blue
working solution Giemsa stain (Wolbach's modification)
Sham Comparator: Negative control
Patients who develops vesicular lesion but not typically considered as herpesviral skin infection, such as acute eczema, Paederus dermatitis
working solution methylene blue
working solution Giemsa stain (Wolbach's modification)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: 24 weeks
Positive results from staining compared with number of cases
24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pawinee Rerknimitr, MD, MSc, Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2017

Primary Completion (Anticipated)

December 7, 2017

Study Completion (Anticipated)

March 6, 2018

Study Registration Dates

First Submitted

June 2, 2017

First Submitted That Met QC Criteria

June 5, 2017

First Posted (Actual)

June 7, 2017

Study Record Updates

Last Update Posted (Actual)

August 4, 2017

Last Update Submitted That Met QC Criteria

August 3, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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