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 @ 12:41 PM
Ignite Modification Date:
2025-12-24 @ 12:41 PM
NCT ID:
NCT03417661
Eligibility Criteria:
Inclusion Criteria:
* Male and female participants 18 - 70 years, who have provided written informed consent to participate in the study
* Test sites with a bacterial baseline count of ≥ 5.0 log10/cm2 at the inguinal (groin) test administration sites. ≥4.0 log10/cm2 at the abdominal test site and \>3.0 log10/cm2 at the clavicular and/or median cubital regions at Day - 5 of screening
* Participants, who in the opinion of the Investigator, are in suitable health for inclusion in the study.
Exclusion Criteria:
* Exposure of the test sites to strong detergents, solvents or other irritants during the 14- day pre-test conditioning period or during the test period.
* Use of systemic or topical antibiotic medications, steroid medications or any other product known to affect the normal microbial flora of the skin, up to 1 month prior to the screening period, during the 14-day pre-test conditioning period or during the test period.
* Any known allergies to latex (rubber), alcohols, tape adhesives or to common antibacterial agents found in soaps, lotions or ointments, particularly chlorhexidine gluconate or chlorine.
* Active skin rashes or breaks in the skin at the test site.
* Active skin diseases or inflammatory skin conditions including contact dermatitis within 10cm of the test site.
* Showering or bathing after the Day -5 baseline sampling and unwilling to refrain from showering or bathing whilst at Surrey CRC (Day 0 to Day 1).
* Participation in another clinical trial within 90 days preceding randomisation.
* Pregnant or breastfeeding women.
* Any other medical condition, which in the opinion of the Investigator, should preclude participation.
* Unwillingness to fulfil the performance requirements of the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03417661
Study Brief:
Protocol Section:
NCT03417661