Tzanck Smear With Methylene Blue Stain for Herpes

NCT ID: NCT03178747

Last Updated: 2017-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-07

Study Completion Date

2018-03-06

Brief Summary

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

Detailed Description

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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.

Conditions

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Herpes Simplex Herpes Zoster Varicella Zoster

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Case

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

Group Type ACTIVE_COMPARATOR

Methylene blue

Intervention Type DIAGNOSTIC_TEST

working solution methylene blue

Giemsa stain

Intervention Type DIAGNOSTIC_TEST

working solution Giemsa stain (Wolbach's modification)

Negative control

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

Group Type SHAM_COMPARATOR

Methylene blue

Intervention Type DIAGNOSTIC_TEST

working solution methylene blue

Giemsa stain

Intervention Type DIAGNOSTIC_TEST

working solution Giemsa stain (Wolbach's modification)

Interventions

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Methylene blue

working solution methylene blue

Intervention Type DIAGNOSTIC_TEST

Giemsa stain

working solution Giemsa stain (Wolbach's modification)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dermatological Society of Thailand

OTHER

Sponsor Role collaborator

Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Pawinee Rerknimitr

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pawinee Rerknimitr, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

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Division of Dermatology, Faculty of Medicine, Chulalongkorn University

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Pawinee Rerknimitr, MD, MSc

Role: CONTACT

+6622564253

Facility Contacts

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Pawinee Rerknimitr, MD, MSc

Role: primary

+6622564253

Other Identifiers

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674/59

Identifier Type: -

Identifier Source: org_study_id

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