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Tzanck Smear With Methylene Blue Stain for Herpes

Primary Purpose

Herpes Simplex, Herpes Zoster, Varicella Zoster

Status

Unknown status

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

Methylene blue

Giemsa stain

About this trial

This is an interventional diagnostic trial for Herpes Simplex focused on measuring Methylene blue, Giemsa, Tzanck smear

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Division of Dermatology, Faculty of Medicine, Chulalongkorn UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Case

Negative control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Sensitivity

Positive results from staining compared with number of cases

Secondary Outcome Measures

Factors that contribute the results from Methylene blue staining

Subgroup analysis which included age, sex, clinical morphology, distribution, duration of lesion.

Specificity

Full Information

NCT ID

NCT03178747

First Posted

June 2, 2017

Last Updated

August 3, 2017

Sponsor

Chulalongkorn University

Collaborators

Dermatological Society of Thailand

1. Study Identification

Unique Protocol Identification Number

NCT03178747

Brief Title

Tzanck Smear With Methylene Blue Stain for Herpes

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Unknown status

Study Start Date

March 7, 2017 (Actual)

Primary Completion Date

December 7, 2017 (Anticipated)

Study Completion Date

March 6, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chulalongkorn University

Collaborators

Dermatological Society of Thailand

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Herpes Simplex, Herpes Zoster, Varicella Zoster

Keywords

Methylene blue, Giemsa, Tzanck smear

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Non-Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Case

Arm Type

Active Comparator

Arm Description

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

Arm Title

Negative control

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Methylene blue

Intervention Description

working solution methylene blue

Intervention Type

Diagnostic Test

Intervention Name(s)

Giemsa stain

Intervention Description

working solution Giemsa stain (Wolbach's modification)

Primary Outcome Measure Information:

Title

Sensitivity

Description

Positive results from staining compared with number of cases

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Factors that contribute the results from Methylene blue staining

Description

Subgroup analysis which included age, sex, clinical morphology, distribution, duration of lesion.

Time Frame

24 weeks

Title

Specificity

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pawinee Rerknimitr, MD, MSc

Phone

+6622564253

pawinee.r@chula.ac.th

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pawinee Rerknimitr, MD, MSc

Organizational Affiliation

Chulalongkorn University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Division of Dermatology, Faculty of Medicine, Chulalongkorn University

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pawinee Rerknimitr, MD, MSc

Phone

+6622564253

pawinee.r@chula.ac.th

First Name & Middle Initial & Last Name & Degree

Kittipong Wantavornprasert, MD

First Name & Middle Initial & Last Name & Degree

Pokrath Hansasuta, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Tzanck Smear With Methylene Blue Stain for Herpes

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