Herper ZosterNCT05685797
Biomarker Study in Patients With Herpes Zoster
A study testing Herpes zoszter (acute)with inter vention in people with Herper Zoster, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
Investigators performed this study to investigate the expression levels inflammatory cytokine and neurotransmitters (calcitonin gene-related peptide (CGRP), substance P (SP), vasoactive intestinal peptide (VIP), and β-endorphin) in peripheral blood of participants with herpes zoster. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Herper Zoster
- What is being tested?
- Herpes zoszter (acute)with inter vention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jan 2023to 30 Nov 2023
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with NRS more than 4
- patients who failed medical treatment
- patients showing severe adverse reaction with medication
Who cannot join
- Patients showing allergic reaction to local anesthetics
- Patients with coagulation abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inflammatory Cytokine and Neuropeptide Study in Patients With Herpes Zoster
Investigators performed this study to investigate the expression levels inflammatory cytokine and neurotransmitters (calcitonin gene-related peptide (CGRP), substance P (SP), vasoactive intestinal peptide (VIP), and β-endorphin) in peripheral blood of participants with herpes zoster.
Read the detailed description
Sudden and electrick shooting sensation of face is an important clinical feature of herpes zoster. The severe and excruciating nature of pain intensity associated with herpes zoster can impair the physical and psychosocial well-being of the patient, however, pathophysiologic mechanism of herpes zoster still remains unclear.
Recentrly, there have been a few studies suggesting biomarker levels in the blood and CSF level, however, further study is required to elucidate the action mechanism.
Up to 90% of patients can achieve pain reduction using medical therapy alone. However, 10% -15% of herpes zoster cases demonstrate a minimal response to medication with various side effects. Radiofrequency thermocoagulation (RFT) of the trigeminal ganglion is an alternative treatment option for patients who are poor candidates for microvascular decompression or show serious side effects to medication. Recent study revealed that RFT of the trigeminal ganglion resulted in Barrow Neurological Institute (BNI) pain scale I or II in 71.7% of patients, with a median time to recurrence of 36 months.
Although patients experience significant pain relief after RFT, it is uncertain whether inflammatory cytokine and neurocytokine (CGRP, substance P, VIP) are reduced.
- Conditions
- Herper Zoster
- Being tested
- Herpes zoszter (acute)with inter vention
- Keywords
- herpes zoster, cytokine, neurotransmitter
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herpes zoszter (acute)with inter ventionProcedure or surgery
nerve block
| Study group | Role | What they receive |
|---|---|---|
| herpes zoster (acute) patients with intervention | Experimental | Patients with herpes zoster receiving 2 times of nerve block Receives: Procedure: Herpes zoszter (acute)with inter vention |
| patients with chronic herpes zoster receiving 2 times of nerve block | Experimental | Patients with herpes zoster receiving 2 times of nerve block Receives: Procedure: Herpes zoszter (acute)with inter vention |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum level of inflammatory cytokine changes during 3 time period
inflammatory cytokine including Tumor necrosis factor-alpha, Interleukin-6 changes during 3 time period Higher score means worse outcome
Measured: Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation
serum level of neurotransmitter changes during 3 time period
neurotransmitter including Calcitonene gene related peptide, substance P, vasoactive intestitinal polypeptide changes during 3 time period Higher score means worse outcome
Measured: Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation
Secondary outcomes (1)
Changes of numerical rating scale changes during 3 time period
numerical rating scale changes during 3 time period
Measured: Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start25 Jan 2023
- Primary completion30 Oct 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herper ZosterStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Hee Hong, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685797
- Sponsor's protocol ID
- 2022-09-016
- Status last verified
- Jul 2023
- First submitted
- 15 Dec 2022
- Last updated
- 25 Sep 2025
- 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 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Cytokine and Neuropeptide Study in Patients With Herpes Zoster
- ClinicalTrials.gov ID
- NCT05685797
- Acronym / sponsor ID
- 2022-09-016
- Conditions
- Herper Zoster
- Keywords
- herpes zoster, cytokine, neurotransmitter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 17 Jan 2023 (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.
Investigators performed this study to investigate the expression levels inflammatory cytokine and neurotransmitters (calcitonin gene-related peptide (CGRP), substance P (SP), vasoactive intestinal peptide (VIP), and β-endorphin) in peripheral blood of participants with herpes zoster.
Detailed description
Sudden and electrick shooting sensation of face is an important clinical feature of herpes zoster. The severe and excruciating nature of pain intensity associated with herpes zoster can impair the physical and psychosocial well-being of the patient, however, pathophysiologic mechanism of herpes zoster still remains unclear.
Recentrly, there have been a few studies suggesting biomarker levels in the blood and CSF level, however, further study is required to elucidate the action mechanism.
Up to 90% of patients can achieve pain reduction using medical therapy alone. However, 10% -15% of herpes zoster cases demonstrate a minimal response to medication with various side effects. Radiofrequency thermocoagulation (RFT) of the trigeminal ganglion is an alternative treatment option for patients who are poor candidates for microvascular decompression or show serious side effects to medication. Recent study revealed that RFT of the trigeminal ganglion resulted in Barrow Neurological Institute (BNI) pain scale I or II in 71.7% of patients, with a median time to recurrence of 36 months.
Although patients experience significant pain relief after RFT, it is uncertain whether inflammatory cytokine and neurocytokine (CGRP, substance P, VIP) are reduced.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| herpes zoster (acute) patients with intervention | Experimental | Procedure: Herpes zoszter (acute)with inter ventionPatients with herpes zoster receiving 2 times of nerve block |
| patients with chronic herpes zoster receiving 2 times of nerve block | Experimental | Procedure: Herpes zoszter (acute)with inter ventionPatients with herpes zoster receiving 2 times of nerve block |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with NRS more than 4
- patients who failed medical treatment
- patients showing severe adverse reaction with medication
Key exclusion criteria (2 listed)
- Patients showing allergic reaction to local anesthetics
- Patients with coagulation abnormality
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 |
|---|---|---|
| Herpes zoszter (acute)with inter ventionnerve block | Procedure or surgery | herpes zoster (acute) patients with intervention, patients with chronic herpes zoster receiving 2 times of nerve block |
Primary outcome
serum level of inflammatory cytokine changes during 3 time period
Time frame: Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation
inflammatory cytokine including Tumor necrosis factor-alpha, Interleukin-6 changes during 3 time period Higher score means worse outcome
serum level of neurotransmitter changes during 3 time period
Time frame: Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation
neurotransmitter including Calcitonene gene related peptide, substance P, vasoactive intestitinal polypeptide changes during 3 time period Higher score means worse outcome
1 secondary outcome
Changes of numerical rating scale changes during 3 time period
Time frame: Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herpes zoszter (acute)with inter vention in people with Herper Zoster, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 25 Sep 2025. 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum level of inflammatory cytokine changes during 3 time period (time frame: Baseline, 1 week after tigeminal nerve block, 2 weeks after radiofrequency thermocoagulation). The study lists 2 primary outcomes in all. 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 25 Sep 2025.