Tzanck Smear With Methylene Blue Stain for Herpes

Phase 3

• Conditions: Herpes Zoster; Varicella Zoster; Herpes Simplex
• Interventions: Diagnostic Test: Methylene blue; Diagnostic Test: Giemsa stain

• Registration Number: NCT03178747
• Lead Sponsor: Chulalongkorn University

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.

Study Timeline

• Study Start: 2017-03-07
• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-06-05
• Study First Posted: 2017-06-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-03
• Last Update Posted: 2017-08-04
• Primary Completion: 2017-12-07
• Study Completion: 2018-03-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case	Giemsa stain	Patients who clinically diagnosed as herpes simplex, herpes zoster or varicella zoster skin infection.
Case	Methylene blue	Patients who clinically diagnosed as herpes simplex, herpes zoster or varicella zoster skin infection.
Negative control	Methylene blue	Patients who develops vesicular lesion but not typically considered as herpesviral skin infection, such as acute eczema, Paederus dermatitis
Negative control	Giemsa stain	Patients who develops vesicular lesion but not typically considered as herpesviral skin infection, such as acute eczema, Paederus dermatitis

Primary Outcome Measures

Name	Time	Method
Sensitivity	24 weeks	Positive results from staining compared with number of cases

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Division of Dermatology, Faculty of Medicine, Chulalongkorn University; 🇹🇭 Bangkok, Thailand