12-Week Anti-Aging Face Study

PROCEDURES: Visit 1: Potential subjects will report to the Testing Facility with a pre-washed face (at home), without moisturizer or makeup, 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. For 7 days prior to the Test Phase of the trial, subjects will discontinue use of any type of moisturizing 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. 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 with a pre-washed face (at home), without moisturizer or makeup. Male subjects must arrive clean shaven, having shaved the day prior. Subjects’ Conditioning Phase daily diaries will be collected and reviewed for compliance. An Expert Grader will evaluate each subject’s face for evidence redness, swelling, and dryness. Subjects presenting a score of moderate (2) or greater for any one 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 in the crow’s feet area will qualify for the trial. In addition, subjects who exhibit photosensitivity to laser light will not qualify for the trial. To determine final qualification, a clinical technician will verify that the selected forearm is free of visible disease, large tattoos, sunburn, wounds, and/or scars. The technician will place the LED mask on the subject’s forearm, turn on the device, and apply for 10 minutes. If any signs of irritation occur, the subject will be disqualified from the trial. Qualified subjects will equilibrate in the temperature-controlled room for at least 30 minutes. Following equilibration, baseline images (face) and measurements (upper cheek) will be captured. Qualified subjects will be divided into three groups for test material assignment, following a randomization schedule generated by the Testing Facility. Group A = Will receive both the LED mask and cream Group B = Will receive only the LED mask Group C = Will receive only the cream Subjects will be provided with the assigned test material(s) 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.

Visit 3 (Week 6): Subjects will report to the Testing Facility at their scheduled appointment time with their daily diaries, face cream test material (if applicable), and with a pre-washed face (at home), without moisturizer or makeup. Male subjects must arrive clean shaven, having shaved the day prior. Daily diaries will be reviewed for compliance and face cream test materials will be re-weighed. Subjects will equilibrate in the temperature-controlled room for at least 30 minutes, as previously described. While equilibrating, subjects will complete a Sponsor-supplied questionnaire. Following equilibration, images and measurements will be captured at the test site, 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 with a pre-washed face (at home), without moisturizer or makeup. Male subjects must arrive clean shaven, having shaved the day prior. All test materials will be collected, and face creams will be reweighed. Daily diaries will be returned and reviewed for compliance. Subjects will equilibrate in the temperature-controlled room for at least 30 minutes, as previously described. While equilibrating, subjects will complete a Sponsor-supplied questionnaire. Following equilibration, images and measurements will be captured at the test site, as previously described. Subjects will then be dismissed.