Pediatric Bar Soap Study

PROCEDURES Visit 1: Potential subjects and their parent/legal guardian will report to the Testing Facility with clean skin, without having applied any moisturizers or other topical products on their body, at their scheduled appointment time. Subjects aged 7-12 years will execute an AAF after their parent/legal guardian has executed an ICF. Parents/legal guardians will complete a Medical History Form to determine initial qualification of the subject. A Board-Certified Pediatrician will evaluate each subject’s torso (abdomen and back), arms, and legs for evidence of redness, swelling, and dryness. Subjects presenting a score of moderate (2) or greater for at least one parameter will be disqualified. Qualified subjects will be provided with a pre-weighed 4-week supply of the test material, written and verbal instructions, and a daily diary to document use. Each parent/legal guardian will be instructed to use the test material on their child according to the Sponsor-supplied use instructions. Parent/legal guardians may not introduce any new cosmetics, toiletries, or personal care products into the child’s (the subject’s) routine during the trial. Visit 2: After 4 weeks of test material use, subjects and their parent/legal guardian will report to the Testing Facility with clean skin, without having applied any moisturizers or other topical products on their body, at their scheduled appointment time. The test material will be collected and reweighed. Daily diaries will be returned and reviewed for compliance. A Board-Certified Pediatrician will conduct a final evaluation of each subject’s torso (abdomen and back), arms, and legs for evidence of redness, swelling, and dryness, as previously described. A Sponsor-supplied questionnaire will be completed by each parent/legal guardian. The questionnaire will be reviewed for completeness during the visit. Subjects will then be dismissed.