Arm Study - Moisturization, Water Loss and Consumer Perception of a Hand Cream

Visit 1 (Day -7 for Group 1): Potential subjects will report to the Testing Facility at their scheduled appointment time and complete an ICF to become subjects. Subjects will complete a Medical History Form to determine initial qualification. For 5 days prior to the second visit, subjects will discontinue use of any type of moisturizing product on their arms and hands. Subjects will wash their arms two times each day with a non-moisturizing cleanser, provided by the Testing Facility. Subjects will be required to use the provided cleanser for all bathing/showering/handwashing for the entire duration of the trial. A Conditioning Phase daily diary will be provided to each subject to document each washing of their arms. Visit 2 (Day 0): Subjects will report to the Testing Facility at their scheduled appointment time with their Conditioning Phase daily diaries. Daily diaries will be reviewed for compliance and retained by the Testing Facility. Subjects will be examined by an Expert Grader for evidence of dryness. Subjects presenting with a minimum score of “2” on each forearm will qualify for the trial. Subjects will be disqualified if they present with a score greater than “6”. An Expert Grader will also evaluate each subject’s hands for evidence of redness, swelling, and dryness. Subjects presenting a score of moderate (2) or greater for any parameter will be disqualified. Qualified subjects will equilibrate in the temperature-controlled room for at least 30 minutes. For each subject, one 3 cm x 3 cm test site will be marked on each volar forearm. Conversation between the subject and clinical technician will be kept to a minimum. The subjects’ forearms will remain uncovered throughout the test interval. No one will be allowed in the room other than the subjects being evaluated and the clinical technician. Following equilibration, baseline measurements will be captured at each test site. For each subject, one test material treated test site, and one untreated control test site will be assigned following a randomization schedule generated by the Testing Facility. The test material will be applied by a clinical technician using a finger cot, and will be allowed to air dry. Following baseline procedures, subjects will be provided with a pre-weighed 1-week supply of the test material, written and verbal instructions, and a daily diary to document use. Each subject will be instructed to use the test material twice daily. Subjects may not introduce any new cosmetic, toiletry, or personal care products into their routine during the trial. Under clinical supervision, subjects will apply the first application of the test material to their hands according to the Sponsor-supplied use instructions. Immediately post-application, a Sponsor-supplied questionnaire will be administered to each subject. Questionnaires will be reviewed for completeness prior to subjects’ dismissal. Measurements will be captured at each test site on the volar forearm approximately 1 hour, 4 hours, 8 hours, and 12 hours, post application, as previously described. After final measurements have been captured, subjects will be dismissed. Visit 3 (Day 7): After 7 days of test material use, subjects will report to the Testing Facility at their scheduled appointment time. The test material will be collected and reweighed. Daily diaries will be returned and reviewed for compliance. A Sponsor-supplied questionnaire will be completed by each subject and reviewed for completeness prior to subjects’ dismissal. Subjects will then be dismissed from the trial.