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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
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
June 2, 2017
Last Updated
August 3, 2017
Sponsor
Chulalongkorn University
Collaborators
Dermatological Society of Thailand
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
No
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
Email
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
Email
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
No

Learn more about this trial

Tzanck Smear With Methylene Blue Stain for Herpes

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