Scar Cream Study

PROCEDURES: Visit 1 (Day 0): Potential subjects will report to the Testing Facility at their scheduled appointment time with a prewashed test site (at home), without moisturizer or makeup. For test sites on the face, male subjects must arrive clean shaven, having shaved the day prior. Potential subjects will 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 be administered a Baseline Sponsor-supplied questionnaire. An Expert Grader will evaluate each subject’s test site for evidence of redness (around the test site) swelling, dryness, and any other anomalies. Subjects presenting a score of moderate (2) or greater for redness, swelling, or dryness will be disqualified. An Expert Grader will confirm that the scar at the test site appears red and raised in a visible area on the face or body that can be evaluated, photographed, and is accessible for self-application of test material. The location of the test site will be documented. All selected scars will be outlined on a clear plastic template. This outline will be used to return to the same area for subsequent image captures. In addition, the Expert Grader will confirm the test site is free from the following (where applicable): suspicious pigmented lesions, possible skin cancer, visible disease, tattoos, sunburn, wounds, false/extension eyelashes, facial hair, nonremovable piercings, or any other anomaly that may interfere with photographs or evaluations, as deemed by the PI. If necessary, hair will be clipped at the test site on the body by a clinical technician. Qualified subjects will equilibrate in the temperature controlled room for at least 30 minutes. Following equilibration, for scars on the face, baseline VISIA 2D with PRIMOS 3D images will be captured. For scars on the body, baseline 2D DSLR and PRIMOS-CR 3D image capture will be captured at the test site. Subjects will be provided with a pre-weighed 12-week supply of the test material, a non-moisturizing cleanser for all bathing/showering (for body test sites) or for all face washing (for face test sites), and a daily diary to document use. Each subject will be instructed to use the test material following Sponsor-supplied use instructions. Subjects will be instructed to discontinue all scar treatments and moisturizing products on the test site and use only the provided test material for the trial duration. Subjects may continue using their regular makeup and sunscreen products. Subjects may not introduce the use of any new cosmetic, toiletry, or personal care product during the trial. Subjects will be instructed to follow applicable sun protection guidelines for the test site (i.e., wear a hat and sunglasses, stay in the shade when possible, use sunscreen when engaging in outdoor activities) and to avoid tanning beds for the trial duration. Visit 2 (Week 6): Subjects will report to the Testing Facility at their scheduled appointment time with their daily diaries, test material and with a pre-washed test site (at home), without moisturizer or makeup. For test sites on the face, male subjects must arrive clean shaven, having shaved the day prior. Daily diaries will be reviewed for compliance, and test materials will be re-weighed. If necessary, hair will be clipped at the test site on the body by a clinical technician. Subjects will equilibrate in a temperature controlled room for at least 30 minutes, as previously described. While equilibrating, subjects will complete a Sponsor-supplied questionnaire. The questionnaire will be reviewed for completeness during the visit. Following equilibration, appropriate imaging will be captured at the test site, as previously described. Visit 3 (Week 12): Subjects will report to the Testing Facility at their scheduled appointment time with their daily diaries, test material and with a pre-washed test site (at home), without moisturizer or makeup. For test sites on the face, male subjects must arrive clean shaven, having shaved the day prior. Daily diaries will be reviewed for compliance, and test materials will be collected and re-weighed. If necessary, hair will be clipped at the test site on the body by a clinical technician. Subjects will equilibrate in a temperature-controlled room for at least 30 minutes, as previously described.