- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03178747
Tzanck Smear With Methylene Blue Stain for Herpes
August 3, 2017 updated by: Pawinee Rerknimitr, Chulalongkorn University
A Comparative Study of Tzanck Smear With Methylene Blue Versus Giemsa Stain to Diagnose Herpes Simplex, Herpes Zoster and Varicella Zoster Skin Infections
To compare the sensitivity of Tzanck smear with methylene blue stain versus traditional Giemsa stain in patients with herpes infection.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
150
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pawinee Rerknimitr, MD, MSc
- Phone Number: +6622564253
- Email: pawinee.r@chula.ac.th
Study Locations
-
-
-
Bangkok, Thailand, 10330
- Recruiting
- Division of Dermatology, Faculty of Medicine, Chulalongkorn University
-
Contact:
- Pawinee Rerknimitr, MD, MSc
- Phone Number: +6622564253
- Email: pawinee.r@chula.ac.th
-
Sub-Investigator:
- Kittipong Wantavornprasert, MD
-
Sub-Investigator:
- Pokrath Hansasuta, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Case
Patients who clinically diagnosed as herpes simplex, herpes zoster or varicella zoster skin infection.
|
working solution methylene blue
working solution Giemsa stain (Wolbach's modification)
|
Sham Comparator: Negative control
Patients who develops vesicular lesion but not typically considered as herpesviral skin infection, such as acute eczema, Paederus dermatitis
|
working solution methylene blue
working solution Giemsa stain (Wolbach's modification)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity
Time Frame: 24 weeks
|
Positive results from staining compared with number of cases
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Factors that contribute the results from Methylene blue staining
Time Frame: 24 weeks
|
Subgroup analysis which included age, sex, clinical morphology, distribution, duration of lesion.
|
24 weeks
|
Specificity
Time Frame: 24 weeks
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Pawinee Rerknimitr, MD, MSc, Chulalongkorn University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 7, 2017
Primary Completion (Anticipated)
December 7, 2017
Study Completion (Anticipated)
March 6, 2018
Study Registration Dates
First Submitted
June 2, 2017
First Submitted That Met QC Criteria
June 5, 2017
First Posted (Actual)
June 7, 2017
Study Record Updates
Last Update Posted (Actual)
August 4, 2017
Last Update Submitted That Met QC Criteria
August 3, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 674/59
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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