START DATE10/29/2024
QUALIFICATIONSFemales Ages: 18-54
TIME REQUIREMENT3 visits
COMPENSATION$80
No Prescreening is required for this study.
Conflicting Studies: Any other gynecological, arms, or legs study
Study Description:
Visit 1/Baseline: Subjects will be asked to report to the testing facility for the Baseline visit. Informed consent will be obtained, and Inclusion and Exclusion Criteria will be verified. Subjects will complete a skin sensitivity questionnaire to determine if they have self-perceived sensitive skin. Dermal evaluations will be obtained by a Board-Certified Dermatologist of the arms and legs. Gynecological evaluations will be obtained by a Gynecologist of the Intimate Area (groin, labia minora, labia majora, vestibule/perineum). A feminine pH test strip will be used to obtain the pH value of the subjects’ intimate area by a Board-Certified Gynecologist. Subjective assessments of the arms, legs and Intimate area will be obtained. Subjects will be given the test material, verbal and written instructions regarding study requirements, and a Daily Diary to note each use of the test material. The test material will be counted and weighed prior to distribution.
Visit 2/Week 2: Subjects will return to ECRL with their test product and daily diary. Dermal evaluations will be obtained by a CRC of the arms and legs. Gynecological evaluations will be obtained by a Gynecologist of the Intimate Area (groin, labia minora, labia majora, vestibule/perineum). A feminine pH test strip will be used to obtain the pH value of the subjects’ intimate area by a Board-Certified Gynecologist. Subjective assessments of the arms, legs and Intimate area will be obtained.
Visit 3/Final: Subjects will return to ECRL with their test product and daily diary. Dermal evaluations will be obtained by a Board-Certified Dermatologist of the arms and legs. Gynecological evaluations will be obtained by a Gynecologist of the Intimate Area (groin, labia minora, labia majora, vestibule/perineum). A feminine pH test strip will be used to obtain the pH value of the subjects’ intimate area by a Board-Certified Gynecologist. Subjective assessments of the arms, legs and Intimate area will be obtained. The test materials will be collected, counted, and weighed. Daily diaries will be collected and reviewed for study compliance.
Inclusion Criteria
- Subject is female between 18 – 54 years of age
- Subject has Self-Assessed Sensitive Skin (approximately 50% of the study population) or Self Assessed Non-Sensitive Skin (approximately 50% of the study population) as determined by a Skin Sensitivity Questionnaire.
- Subject exhibits no edema, no greater than barely perceptible (±) erythema, and no greater than slight (1) dryness of the test sites at baseline.
- Subject is a current body wash user at least 5 time per week.
- Subject is willing to use the test product at least 5 times per week.
- Subject is willing to be evaluated in the following areas at all time points; forearms, legs, external genitalia (groin, labia minora, labia majora and vestibule/perineum.
- Female subject is willing to have a vaginal pH swab collected by a nurse or gynecologist.
- Subject agrees not to introduce any new cosmetic or toiletry products during the study.
- Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits.
- Subject is willing to participate in all study evaluations.
- Subject is in generally good health and has a current Panelist Profile Form on file at ECRL.
- Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164.
- Subject understands and has signed an Informed Consent Form in conformance with 21 CFR Part 50: “Protection of Human Subjects.”
Exclusion Criteria
- Subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control.
- Subject has an active vaginal infection, urinary tract infection, or any sexually transmitted disease.
- Subject has tattoos or piercings at or around the test sites.
- Subject has a known or suspected yeast infection or a history of recurrent bladder infections.
- Subject has received treatment with sympathomimetics, antihistamines, vasoconstrictors, non-steroidal anti-inflammatory agents, and/or systemic or topical corticosteroids within one week prior to initiation of the study.
- Subject has a history of acute or chronic dermatologic, medical, and/or physical conditions which would, in the opinion of the Principal Investigator, preclude application of the test materials and/or could influence the outcome of the study.
- Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study.
- Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs.
- Subject has a history of skin cancer or is currently undergoing treatment for active cancer of any kind.
- Subject is an ECRL employee who is working on this study.
- Subject has diabetes.
Study Dates:
V1 25 min Tues. Oct. 29th
V2 25 min Tues. Nov. 12th
V3 25 min Tues. Nov. 26th
Study Times:
7:00 am – 3:45 pm
Call our Recruiting Department for more information.