Tzanck Smear With Methylene Blue Stain for Herpes

Chulalongkorn University

Status and phase: Unknown; Phase 3

Conditions: Herpes Simplex; Varicella Zoster; Herpes Zoster

Treatments: Diagnostic Test: Giemsa stain; Diagnostic Test: Methylene blue

Study type: Interventional

Funder types: Other

Identifiers

NCT03178747

674/59

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

Case

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Giemsa stain

Diagnostic Test: Methylene blue

Negative control

Sham Comparator group

Description:

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

Treatment:

Diagnostic Test: Giemsa stain

Diagnostic Test: Methylene blue