Herpes SimplexPhase 3NCT03178747
Tzanck Smear With Methylene Blue Stain for Herpes
A Phase 3 study testing Methylene blue and Giemsa stain in people with Herpes Simplex and Herpes Zoster, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
To compare the sensitivity of Tzanck smear with methylene blue stain versus traditional Giemsa stain in patients with herpes infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Simplex, Herpes Zoster, Varicella Zoster
- What is being tested?
- Methylene blue and Giemsa stain
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteThailand
- Study dates
- 7 Mar 2017to 6 Mar 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Those who are not willing to have specimen from skin lesions to be collected.
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Division of Dermatology, Faculty of Medicine, Chulalongkorn University
Bangkok, 10330
Pawinee Rerknimitr, MD, MSc, +6622564253, pawinee.r@chula.ac.th
Kittipong Wantavornprasert, MD
About this study
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
To compare the sensitivity of Tzanck smear with methylene blue stain versus traditional Giemsa stain in patients with herpes infection.
Read the 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.
- Conditions
- Herpes Simplex, Herpes Zoster, Varicella Zoster
- Being tested
- Methylene blue, Giemsa stain
- Keywords
- Methylene blue, Giemsa, Tzanck smear
- Medical subject headings
- Herpes Simplex, Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene blueDiagnostic test
working solution methylene blue
Giemsa stainDiagnostic test
working solution Giemsa stain (Wolbach's modification)
| Study group | Role | What they receive |
|---|---|---|
| Case | Active comparator | Patients who clinically diagnosed as herpes simplex, herpes zoster or varicella zoster skin infection. Receives: Diagnostic Test: Methylene blue; Diagnostic Test: Giemsa stain |
| Negative control | Sham comparator | Patients who develops vesicular lesion but not typically considered as herpesviral skin infection, such as acute eczema, Paederus dermatitis Receives: Diagnostic Test: Methylene blue; Diagnostic Test: Giemsa stain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Positive results from staining compared with number of cases
Measured: 24 weeks
Secondary outcomes (2)
Factors that contribute the results from Methylene blue staining
Subgroup analysis which included age, sex, clinical morphology, distribution, duration of lesion.
Measured: 24 weeks
Specificity
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start7 Mar 2017
- Primary completion7 Dec 2017 (estimated)
- Study completion6 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes SimplexStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Dermatological Society of Thailand
- Responsible party
- Principal investigator, Pawinee Rerknimitr, Chulalongkorn University
- Investigators
- Pawinee Rerknimitr, MD, MSc, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178747
- Sponsor's protocol ID
- 674/59
- Status last verified
- Aug 2017
- First submitted
- 2 Jun 2017
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03178747
- Acronym / sponsor ID
- 674/59
- Conditions
- Herpes Simplex, Herpes Zoster, Varicella Zoster
- Keywords
- Methylene blue, Giemsa, Tzanck smear
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Dermatological Society of Thailand
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- 7 Dec 2017 (estimated)
- Study completion
- 6 Mar 2018 (estimated)
- First posted
- 7 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | Active comparator | Diagnostic Test: Methylene blue, Diagnostic Test: Giemsa stainPatients who clinically diagnosed as herpes simplex, herpes zoster or varicella zoster skin infection. |
| Negative control | Sham comparator | Diagnostic Test: Methylene blue, Diagnostic Test: Giemsa stainPatients who develops vesicular lesion but not typically considered as herpesviral skin infection, such as acute eczema, Paederus dermatitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Those who are not willing to have specimen from skin lesions to be collected.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylene blueworking solution methylene blue | Diagnostic test | Case, Negative control |
| Giemsa stainworking solution Giemsa stain (Wolbach's modification) | Diagnostic test | Case, Negative control |
Primary outcome
Sensitivity
Time frame: 24 weeks
Positive results from staining compared with number of cases
2 secondary outcomes
Factors that contribute the results from Methylene blue staining
Time frame: 24 weeks
Specificity
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Herpes Simplex
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pawinee Rerknimitr, MD, MSc principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylene blue and Giemsa stain in people with Herpes Simplex and Herpes Zoster, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pawinee Rerknimitr, MD, MSc (+6622564253, pawinee.r@chula.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.