START DATE10/17/2024
QUALIFICATIONSFemales Ages: 18-60
TIME REQUIREMENT2 visits
COMPENSATION$60
No prescreening is required for this study.
Study Description:
Visit 1/Baseline, Subjects will report to the testing facility. Informed consent will be obtained. Inclusion and exclusion criteria will be verified. Gynecological and underarm exams will be performed by the Principal Investigator (gynecologist) or study nurse and the results will be recorded. pH swabs will be collected and evaluated. The pre-weighed test materials and Daily Diaries will be distributed.
Visit 2/Final, Subjects will return to the testing facility. Gynecological and underarm exams will be performed by the Principal Investigator (gynecologist) or study nurse and the results will be recorded. pH swabs will be collected and evaluated. Test materials will be collected and weighed. Daily diaries will be reviewed for study compliance and collected. Subjects will complete a consumer perception questionnaire.
Inclusion Criteria
- Subject is female, ages 18-60.
- Subject has self-perceived sensitive skin (approximately 100% of the study population).
- Subject is free of any systemic or dermatological disorder (self-reported) including a known history of allergies or other medical conditions which could interfere with the conduct of the study, interpretation of results or increase the risk of adverse reactions.
- Subject agrees not to use any new personal care products or cosmetics other than the test material, during the course of the study.
- Subject is able to complete the study and comply with instructions.
- Subject is able to read and understand English and sign the Informed Consent Form.
- Subject is willing to refrain from the use of any deodorants, powders, sprays, creams, or feminine washes in the vulvar or vaginal area and underarm area other than the test material for the duration of the study.
- Subject is willing to undergo an examination of the underarms, external genitalia and have a vaginal pH swab collected by a nurse or gynecologist.
- Subject is free of any gynecological disorders which may affect test results.
- Subject exhibits no evidence of vaginal infection or vulvar irritation at the baseline examination.
- Subject has signed an Informed Consent Form in compliance with 21 CFR Part 50: “Protection of Human Subjects”
- Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164.
- Subject has a current Panelist Profile Form on file.
Exclusion Criteria
- Subject is pregnant, planning to become pregnant, nursing, or not using adequate birth control during the course of the study.
- Subject who is less than six weeks post-partum (self-reported).
- Subject is expecting to menstruate during any scheduled examination.
- Subject has any skin conditions at or around the test sites that could interfere with the conduct of the study or increase risks to the test subject (e.g. excessive redness or dryness, abnormal pigmentation).
- Subject has known allergies to feminine products (self-reported).
- Subject is taking medications that could interfere with the test results, including sympathomimetics, antihistamines, vasoconstrictors, steroidal or non-steroidal anti-inflammatory agents, and/or systemic or topical corticosteroids within one week prior to initiation of the study.
- Subject is currently under treatment (using prescription medication) for the care/management of asthma or diabetes (insulin-dependent only) based on self-report.
- Subject has an active case of vaginal infections or urinary tract infection.
- Subject has any sexually transmitted disease.
- Subject is currently participating in a clinical research study or has participated in a study involving the underarm area, vulvar, vaginal, or anal area within 14 days of study initiation.
- Subject has psoriasis around the test sites.
- Subject has active atopic dermatitis, eczema, or sunburn at or around the test sites.
- Subject has tattoos or piercings at or around the test sites.
- Subject is an employee of ECRL or their dependents and relatives.
- Subject has participated in an investigational systemic drug study within two weeks of study initiation.
- Subjects with a known or suspected yeast infection or vaginal infection or a history of recurrent bladder or vaginal infections.
- Subject has a history of acute or chronic dermatologic, medical, and/or physical conditions which would preclude application of the test material and/or could influence the outcome of the study.
- Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind.
Study dates:
V1 20 min Thurs. Oct. 17th
No visit mid-study call Thurs. Oct. 24th
V2 20 min Thurs. Oct. 31st
Appointment times: 7:30 am – 3:45 pm