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:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT01484067
Eligibility Criteria:
Inclusion Criteria:
* Female or male 18-70 years old in good general health
* Has a history of Herpes Labialis in the areas and with the frequency defined in the protocol.
* Based on history, likely to experience a cold sore outbreak within next 2 to 3 months
* Willing to provide informed consent
* Willing to stop all other treatment of this condition and any topical products (lip balm, cosmetics, sunscreen) during test period
* Women of child bearing potential must agree to use an adequate method of birth control (systemic birth control/intrauterine device)
Exclusion Criteria:
* Self-reported to be pregnant, planning to become pregnant or nursing
* Has any medical history or condition that might, per protocol or in the opinion of the investigator, compromise the subject's safety or the analysis of results.
* Is taking or has taken within the 28 days before commencing treatment, protocol-specified medications or herbal supplements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01484067
Study Brief:
Protocol Section:
NCT01484067