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 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
NCT ID:
NCT03977792
Eligibility Criteria:
Inclusion Criteria:
* Provide signed informed consent and willing to comply with study-related procedures;
* Males and females ≥18 years of age at screening;
* Diagnosed with recurrent herpes labialis, defined as showing at least 2 episodes of infections per year;
* Willing to avoid, during the treatment phase, the use of anti-inflammatory, anti-herpetic, antibiotic and antiviral agents as well as steroids or other natural products that would interfere with the immune system response (exception: only the use of valacyclovir will be permitted, if prescribed);
* Willing to avoid, during the treatment phase, the use of cosmetic products (ex. cream, make-up, etc.) at areas close to the infected region.
Exclusion Criteria:
* Patients with skin disease affecting the peribuccal region (eczema, psoriasis, dermatitis, etc.);
* Patients with herpes labialis occurring within 14 days prior to screening;
* Patients known for allergies or intolerance to drug and comparator ingredients, or any cream used to treat skin conditions;
* Treatment with an investigational product or biological agent or device within 30 days or five half˗lives, whichever is longer.
* Any other condition, which, in the opinion of the investigator or the sponsor would make the patient unsuitable for inclusion, or could interfere with the conduct of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03977792
Study Brief:
Protocol Section:
NCT03977792