Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
NCT ID:
NCT03080961
Eligibility Criteria:
Inclusion Criteria:
1. Participant is male or female and at least 18 years of age
2. HSV-2 seropositive by the UW Western blot or Alegria assay
3. History of recurrent genital herpes with at least 3 recurrences in the last year or, if currently on suppressive/ prophylactic therapy, prior to starting the therapy (antiviral therapy has to be stopped at least 7 days prior to initiation of the trial product).
4. General good health at the discretion of the investigator.
5. Willing to not use any topical genital therapy aside from the study device for the duration of the trial.
6. Willing to not use any systemic anti HSV therapy during the entire study starting 7 days prior to baseline.
7. Willing to obtain 2 swabs from external-genital areas once daily for the duration of the trial.
8. Willing to keep a daily trial diary during the treatment period.
9. Negative pregnancy test for women at screening.
10. Willing to use contraceptives for the duration of the study.
11. Subject must be willing and able (in the opinion of the investigator) to understand the patient information and informed consent form and to comply with the clinical trial protocol and procedures.
12. Subject must be willing to give written informed consent.
Exclusion Criteria:
1. Serious medical conditions, such as diabetes, significant autoimmune disease, cancer or immunosuppression, etc. that at the discretion of the investigator will likely affect study outcomes
2. Treatment with systemic steroids or other immune-modulating agents
3. Participation in any investigational drug or device trial within 30 days prior to screening.
4. Pregnancy or breastfeeding, in case of women.
5. Any other conditions that in the judgment of the investigator would preclude successful completion of the clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03080961
Study Brief:
Protocol Section:
NCT03080961