Recruiting

Observational Study

Sponsor:

Center for Clinical Studies, Texas

Code:

NCT06903078

Conditions

Herpes Zoster (HZ)

Vascular Dementia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The purpose of this observational research study is to study if patients with herpes zoster, also known as Shingles, have a higher risk of vascular dysfunction (problems with blood vessels, including stroke) and vascular dementia (problems with mental decline as a result of decreased blood flow to the brain) compared to patients without herpes zoster.

Patients are evaluated based on the group they are assigned too:

1. Herpes Zoster (HZ) Group: individuals presenting with untreated herpes zoster. These participants will have 6 visits:

  • Day 1 = 1st day presenting to clinic with acute zoster
  • 7 days post zoster
  • 1 month after Day 1
  • 3 months after Day 1
  • 6 months after Day 1
  • 12 months after Day 1
2. Control Group: individuals without herpes zoster o Day 1 (only 1 visit will be completed)

This study does not have a study medication/device. Standard of care for all patients will be followed.

Conditions

Herpes Zoster (HZ)

Vascular Dementia

Study ID

NCT06903078

Start date

Feb 13, 2025

Status verified date

Dec, 2025

Completion date

Aug, 2030

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

At the Screening Visit (Visit 1/Day 1), all participants must meet all the following criteria in order to be considered for participation in the study:

1. Be a male or female ≥ 18 years of age.
2. Present to clinic for routine dermatologic evaluation with or without rash.
3. Are willing and able to complete study visits and procedures, and able to effectively communicate with the investigator and other study personnel.
4. Have adequate venous access and are willing to undergo venipuncture for blood draws.
5. Able to provide written informed consent prior to any study procedures. Additional inclusion criteria for Herpes zoster (HZ) participants,
6. Present with acute, vesicle-stage HZ that has not been treated with antiviral therapies
7. Are willing and have reliable transportation to complete additional follow-up visits at 7 days, 1 month, 3 months, 6 months, and 12 months after initial visit for acute HZ.

Exclusion Criteria:

At the Screening Visit (Visit 1/Day 1), participants meeting any of the following criteria will be excluded from participation in the study:

1. Female individuals who are pregnant or breast-feeding.
2. Receiving systemic or topical antivirals for varicella zoster virus (VZV).
3. Sensitivity or allergy to systemic or topical antiviral medications for HZ.
4. History of diagnosed HZ within the last 8 years.
5. Received a HZ vaccine (e.g., Zostavax®/Shingrix®) within the last 8 years.
6. Received any vaccinations within the last 3 months.
7. Currently taking immunosuppressive therapies, including medications and radiation.
8. Currently taking any anticoagulants.
9. History of any coagulation disorder(s).
10. History of end-stage renal disease or uremia.
11. History of end-stage liver disease.
12. History of HIV.
13. Have had a COVID-19 infection in last 3 months.
14. Any history of non-skin cancers within the last 3 months.
15. History of serious infection requiring hospitalization in the last 3 months.
16. Prior history of cardiovascular accident or myocardial infarction within the last 12 months.
17. Prior cerebrovascular accident in the past 12 months.

Study Design

Enrollment

375 participants

Anticipated

Interventions and Outcome Measures

Arms

HZ (Herpes Zoster) Group

Participants with untreated acute herpes zoster outbreak.

Control Group

Participants without acute herpes zoster outbreak.

Primary outcome measure

  • Analyze exosome content for known vascular damaging proteins/miRNAs from matched control and HZ individuals over a 12-month period. [ Time Frame: From enrollment throughout the 5-year proposal period, occurring in a cyclical and overlapping manner. ]

Central Contacts and Locations

Central contacts

Study Principal Investigator

281-333-2288info@ccstexas.com

Locations

Center for Clinical Studies, LTD. LLP

Recruiting

Houston, Texas, United States, 77004

Contacts

Stephen K. Tyring, MD

713-528-8818info@ccstexas.com

Mario Guerrero

info@ccstexas.com

Principal Investigator:

Stephen K. Tyring, MD

Center for Clinical Studies, LTD. LLP

Recruiting

Webster, Texas, United States, 77598

Contacts

Principal Investigator:

Stephen K Tyring, MD

More Information

Sponsor

Center for Clinical Studies, Texas

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Keywords

  • RO1
  • 1R01AG085406-01
  • Herpes Zoster
  • Shingles
  • Dr. Stephen Tyring
  • Dementia risk HZ
  • VZV

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Center for Clinical Studies, Texas on 2025-12-11.