Tzanck Smear With Methylene Blue Stain for Herpes
A Comparative Study of Tzanck Smear With Methylene Blue Versus Giemsa Stain to Diagnose Herpes Simplex, Herpes Zoster and Varicella Zoster Skin Infections
1 other identifier
interventional
150
1 country
1
Brief Summary
To compare the sensitivity of Tzanck smear with methylene blue stain versus traditional Giemsa stain in patients with herpes infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2017
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 7, 2017
CompletedFirst Submitted
Initial submission to the registry
June 2, 2017
CompletedFirst Posted
Study publicly available on registry
June 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2018
CompletedAugust 4, 2017
August 1, 2017
9 months
June 2, 2017
August 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity
Positive results from staining compared with number of cases
24 weeks
Secondary Outcomes (2)
Factors that contribute the results from Methylene blue staining
24 weeks
Specificity
24 weeks
Study Arms (2)
Case
ACTIVE COMPARATORPatients who clinically diagnosed as herpes simplex, herpes zoster or varicella zoster skin infection.
Negative control
SHAM COMPARATORPatients who develops vesicular lesion but not typically considered as herpesviral skin infection, such as acute eczema, Paederus dermatitis
Interventions
working solution Giemsa stain (Wolbach's modification)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Those who are not willing to have specimen from skin lesions to be collected.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chulalongkorn Universitylead
- Dermatological Society of Thailandcollaborator
Study Sites (1)
Division of Dermatology, Faculty of Medicine, Chulalongkorn University
Bangkok, 10330, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pawinee Rerknimitr, MD, MSc
Chulalongkorn University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
June 2, 2017
First Posted
June 7, 2017
Study Start
March 7, 2017
Primary Completion
December 7, 2017
Study Completion
March 6, 2018
Last Updated
August 4, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share