Women's Shower Oil
If you are eligible for the study and you choose to participate, you will:
PROCEDURES: Women’s Shower Oil Visit 1: Potential subjects will report to the Testing Facility at their scheduled appointment time with clean skin, without having applied any products to the test sites, and complete an ICF to become subjects. Subjects will complete a Medical History Form to determine initial qualification. The date of onset of last menses will be recorded, if applicable. An Expert Grader will evaluate each subject’s upper chest, arms (elbows to wrist), and legs (knees to ankles) for evidence of erythema, edema, and dryness. Subjects presenting a score of moderate (2) or greater for at least one parameter will be disqualified.. Subjects will undergo a complete gynecological examination by a Board-Certified Gynecologist for evidence of any vulvar, vaginal, or perineal inflammation or irritation. The examination will include the use of a plastic speculum, which will be rotated through 180 to insure visualization of the entire vaginal wall and cervix. In addition, subjects will be evaluated for erythema, edema, dryness, and evidence of any unusual dryness, pustules, or fissures. For qualification into the trial, the gynecological examination must be within a normal range (i.e., less than grade 2). Qualified subjects will be provided with a pre-weighed 4-week supply of the test material and a daily diary to document use. Written and verbal instructions for use, supplied by the Sponsor, will be provided for each subject. Subjects will be instructed to discontinue the use of their current body cleansing products and use only the test material provided. Subjects may continue to use their current form of application i.e., loofa or hands. Subjects may not introduce any new cosmetic, toiletry, or personal care product during the trial. Visit 2: After 4 weeks of test material use, subjects will arrive at the Testing Facility at their scheduled appointed time with clean skin, without having applied any products to the test sites. The date of onset of last menses will be recorded, if applicable. The test material will be collected and reweighed. Daily diaries will be returned and reviewed for compliance. Final examinations will be conducted by an Expert Grader and Board-Certified Gynecologist, as previously described. Subjects will then be dismissed from the trial.
70 New Dutch Lane, Fairfield, NJ
973-359-5879
Monday - Thursday: 7:30AM - 7:30PM
Friday: 7:30AM - 7:00PM