Arm Moisturization Study

PROCEDURES:

Visit 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 7 days prior to the Test Phase (Day 0) of the trial, subjects will discontinue use of any type of moisturizing product on their arms. 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. A Conditioning Phase daily diary will be provided to each subject to document each forearm washing.

Visit 2 (Day 0): Subjects will report to the Testing Facility at their scheduled appointment time with their Conditioning Phase daily diaries. The diaries will be reviewed for compliance and retained. Subjects will be examined by an Expert Grader for evidence of dryness. Subjects presenting with a minimum score of 2 on each volar forearm will qualify for the trial. Subjects will be disqualified if they present with a score greater than 6. Qualified subjects will then equilibrate in the temperature-controlled room for at least 30 minutes.

For each qualified subject, three 3 cm x 3 cm test sites will be marked on the subject’s right volar forearm, and two 3 cm x 3 cm test sites will be marked on the left forearm. The volar forearms of subjects will remain uncovered for the duration of Day 0. Conversation between the subject and clinical technician will be kept to a minimum. No one will be allowed in the temperature-controlled room other than the subjects being evaluated and the clinical technician conducting the needed procedures. Following equilibration, pre-application measurements will be captured at each test site. Four test sites will be designated for a single application of the appropriate test material, with one test site remaining as an untreated control. The test sites will be assigned according to a randomization schedule generated by the Testing Facility.

Using a finger cot, a technician will apply the test material to the appropriate test site. The test sites will be allowed to dry. Measurements will be captured again at each test site approximately 30 minutes post-application. Once final measurements are completed, subjects will then be dismissed from the trial.