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NCT03178747 Clinical Trial

Tzanck Smear With Methylene Blue Stain for Herpes

Herpes Zoster Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03178747
Other study ID # 674/59
Secondary ID
Status Recruiting
Phase Phase 3
First received June 2, 2017
Last updated August 3, 2017
Start date March 7, 2017
Est. completion date March 6, 2018

Study information
Verified date August 2017
Source Chulalongkorn University
Contact Pawinee Rerknimitr, MD, MSc
Phone +6622564253
Email pawinee.r@chula.ac.th
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date March 6, 2018
Est. primary completion date December 7, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Methylene blue
working solution methylene blue
• Giemsa stain
working solution Giemsa stain (Wolbach's modification)

Locations
Country Name City State
Thailand Division of Dermatology, Faculty of Medicine, Chulalongkorn University Bangkok

Sponsors (2)
Lead Sponsor Collaborator
Chulalongkorn University Dermatological Society of Thailand

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity Positive results from staining compared with number of cases 24 weeks
Secondary Factors that contribute the results from Methylene blue staining Subgroup analysis which included age, sex, clinical morphology, distribution, duration of lesion. 24 weeks
Secondary Specificity 24 weeks
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