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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT01368120
Eligibility Criteria:
Inclusion Criteria:
* Are ≥ 18 years of age and ≤ 65 years of age
* Are in good health, as evidenced by response to the demographics/dermatological medical history form
* Are willing to refrain from using antimicrobial soaps for bathing and showering during the entire study
* Are willing to refrain from swimming in chemically treated pool or hot tub for duration of study
* Are willing to refrain from using antimicrobial/medicated lotions and creams for duration of study, unless prescribed by a physician for an intercurrent illness
* Are willing to refrain from using topical or systemic antibiotic medication for duration of study, unless prescribed by a physician for an intercurrent illness
* Are willing to refrain from use of body powders and fabric softeners
* Are willing to use soap and shampoo and antiperspirant/deodorant provided exclusively during study
* Have qualification screening bacterial counts of ≥ 2.5 log10 CFU/cm² on two contralateral sites on the upper back
* Are willing to comply with all study protocol requirements
Exclusion Criteria:
Subjects will not be enrolled in the study if they:
* Are currently pregnant or lactating
* Have been exposed to topical or systemic antimicrobials during two weeks proceeding treatment. This restriction will include, but is not limited to shampoos, lotions, soaps, body powders, and materials such as solvents, acids, or alkalis
* Have known soap, detergent, antibiotic and/or perfume allergies
* Have been medically diagnosed as having a medical condition that precludes participation, such as: diabetes, hepatitis, an organ transplant, a medical surgical implant or an immune compromised system
* Have any medical condition which in the opinion of the Investigator prelude participation
* Have swam in chemically treated pools or hot tubs two weeks prior to any microbial sampling
* Have used UV tanning lamps two weeks prior to any microbial sampling
* Have tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders on test sites
* Have bathed or showered less than 48 hours prior to any microbial sampling
* Have known sensitivity to adhesive products, or to materials used in test articles
* Have participated in any type of back wash study within 7 days prior to study
* Have a known sensitivity to latex products
* Are not willing to fulfill the requirements of the protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01368120
Study Brief:
Protocol Section:
NCT01368120