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Tzanck Smear With Methylene Blue Stain for Herpes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03178747
Recruitment Status : Unknown
Verified August 2017 by Pawinee Rerknimitr, Chulalongkorn University.
Recruitment status was:  Recruiting
First Posted : June 7, 2017
Last Update Posted : August 4, 2017
Dermatological Society of Thailand
Information provided by (Responsible Party):
Pawinee Rerknimitr, Chulalongkorn University

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

Condition or disease Intervention/treatment Phase
Herpes Simplex Herpes Zoster Varicella Zoster Diagnostic Test: Methylene blue Diagnostic Test: Giemsa stain Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Comparative Study of Tzanck Smear With Methylene Blue Versus Giemsa Stain to Diagnose Herpes Simplex, Herpes Zoster and Varicella Zoster Skin Infections
Actual Study Start Date : March 7, 2017
Estimated Primary Completion Date : December 7, 2017
Estimated Study Completion Date : March 6, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Case
Patients who clinically diagnosed as herpes simplex, herpes zoster or varicella zoster skin infection.
Diagnostic Test: Methylene blue
working solution methylene blue

Diagnostic Test: Giemsa stain
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
Diagnostic Test: Methylene blue
working solution methylene blue

Diagnostic Test: Giemsa stain
working solution Giemsa stain (Wolbach's modification)

Primary Outcome Measures :
  1. Sensitivity [ Time Frame: 24 weeks ]
    Positive results from staining compared with number of cases

Secondary Outcome Measures :
  1. 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.

  2. Specificity [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03178747

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Contact: Pawinee Rerknimitr, MD, MSc +6622564253

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Division of Dermatology, Faculty of Medicine, Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Contact: Pawinee Rerknimitr, MD, MSc    +6622564253   
Sub-Investigator: Kittipong Wantavornprasert, MD         
Sub-Investigator: Pokrath Hansasuta, MD, PhD         
Sponsors and Collaborators
Chulalongkorn University
Dermatological Society of Thailand
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Principal Investigator: Pawinee Rerknimitr, MD, MSc Chulalongkorn University

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Responsible Party: Pawinee Rerknimitr, Assistant professor, Chulalongkorn University Identifier: NCT03178747    
Other Study ID Numbers: 674/59
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pawinee Rerknimitr, Chulalongkorn University:
Methylene blue
Tzanck smear
Additional relevant MeSH terms:
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Herpes Zoster
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Varicella Zoster Virus Infection
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action