12 Week Face Cream Study

PROCEDURES: Visit 1 (Day -7): Potential subjects will report to the Testing Facility and complete an ICF and a Photographic Release Form. Those who complete an ICF will become subjects. Subjects will complete a Medical History Form to determine initial qualification. Subjects will also complete a Sponsor supplied demographics/self-assessment questionnaire. For 7 days prior to the Test Phase of the trial, subjects will discontinue use of any type of skincare product on their face. Subjects will wash their face two times each day with a non-moisturizing cleanser, provided by the Testing Facility. Subjects will be required to use the provided cleanser exclusively, in both the Conditioning Phase and Test Phase of the trial. Subjects will be instructed to refrain from using any skincare products on their face, to not introduce the use of any new cosmetic, toiletry, or personal care products, and to avoid daily direct ultraviolet radiation exposure on their face, whether natural (sun) or artificial (tanning bed) for the trial duration. A daily diary will be provided to each subject to document each cleansing of the face. Visit 2 (Day 0): Subjects will report to the Testing Facility at their scheduled appointment time with their Conditioning Phase daily diaries, and without moisturizer or makeup on their face. Male subjects must arrive clean shaven, having shaved the day prior. Subjects will wash their face at the Testing Facility with the non-moisturizing cleanser. Subjects’ Conditioning Phase daily diaries will be collected and reviewed for compliance. An Expert Grader will evaluate each subject’s face for evidence of redness, swelling, dryness, and any other anomalies. Subjects presenting a score of moderate (2) or greater for any parameter will be disqualified. An Expert Grader will conduct an evaluation of each subject’s face for wrinkles around the eyes (crow’s feet). Subjects presenting a score of mild to moderate wrinkles will qualify for the trial. Qualified subjects will equilibrate in a temperature controlled room for at least 30 minutes. After equilibration, a Bioinstrumentation technician will take 2D and 3D images of the face, as well as moisture and elasticity measurements of the face. Subjects will be provided with the pre-weighed test material and a daily diary to document use. Comments regarding test material experiences and attributes will be recorded on the daily diary. Written and verbal Sponsor-supplied use instructions will be provided to each subject. Subjects may continue using their regular facial makeup and sunscreen products. Subjects may not introduce the use of any new cosmetic, toiletry, or personal care product during the trial. Visit 3 (Week 6): Subjects will report to the Testing Facility at their scheduled appointment time with their daily diaries, test materials, and without moisturizer or makeup on their face. Male subjects must arrive clean shaven, having shaved the day prior. Subjects will wash their face at the Testing Facility with the non-moisturizing cleanser. Daily diaries will be reviewed for compliance. Test materials will be re-weighed and returned to each subject. Subjects will equilibrate in a temperature controlled room for at least 30 minutes. While equilibrating, subjects will complete a Sponsor-supplied self-assessment questionnaire The questionnaire will be reviewed for completeness during the visit. After equilibration, a Bioinstrumentation technician will take measurements and images of the face, as previously described. Visit 4 (Week 12): Subjects will report to the Testing Facility at their scheduled appointment time with their daily diaries, test materials, and without moisturizer or makeup on their face. Male subjects must arrive clean shaven, having shaved the day prior. Subjects will wash their face at the Testing Facility with the non-moisturizing cleanser. All test materials will be collected and reweighed. Daily diaries will be returned and reviewed for compliance. Subjects will equilibrate in a temperature controlled room for at least 30 minutes, as previously described. While equilibrating, subjects will complete a Sponsor-supplied self-assessment questionnaire. The questionnaire will be reviewed for completeness during the visit. A Bioinstrumentation technician will take measurements and images of the face, as previously described. Subjects will then be dismissed.