Evaluation of the Safety and Tolerability of a Brightening Treatment Paired With a Skincare Regimen

Overview

A12-week single-center, open-label, clinical study is being conducted to assess the efficacy and tolerability of the Brightening Treatment paired with a skincare regimen on healthy female subjects aged 20-65 years with Fitzpatrick Skin Types I - VI and moderate global facial pigmentation due to sun exposure, blemishes, and/or procedures when applied by a clinician in a series of 4 sessions at 2-week intervals. The procedure in this clinical study will include the brightening treatment, retinol serum, and a post-procedure cream. The study visits include baseline, week 2, 6, and 12.

A 12-week, single-center, open-label, clinical case study evaluating the efficacy and tolerability of a Brightening Treatment paired with a skincare regimen on healthy female subjects aged 20-65 years with Fitzpatrick Skin Types I - VI and moderate global face pigmentation when applied by a clinician in a series of 4 sessions at 2-week intervals. At Visit 1 (Screening, Day -7), subjects will review and sign an Informed Consent Form (ICF) and photography release form. Subjects will then be screened for eligibility, and qualified subjects will commence a 7-day pre-treatment skincare regimen and be scheduled for the baseline visit. Subjects will be provided with the Gentle Foaming Cleanser, Vitamin C Serum, and a Broad-Spectrum Sunscreen SPF 50 to be used for the 7-day pre-treatment skincare regimen period along with skincare regimen instructions. Clinical assessments will be performed including Investigator Clinical Efficacy Grading, Investigator Tolerability Grading, Subject Tolerability Grading, VISIA®-CR or Apple iPad Imaging, Antera® Imaging, and Self-Assessment Questionnaires. At Visit 2 (Baseline, Day 0) if subjects continue to meet eligibility, then subjects will receive their 1st Brightening Treatment (3 layers). At Visits 3, 4, and 5 (weeks 2, 4 and 6), subjects will return to the clinical site to receive 2nd, 3rd, and 4th Brightening Treatment (4, 5, and 5 layers, respectively). Various assessments will be performed before and after the procedure and will include Investigator Clinical Efficacy Grading, Investigator Tolerability Grading, Subject Tolerability Grading, Subject Sensitivity Grading, Investigator Skin Frosting Evaluation, VISIA®-CR Imaging, Antera® Imaging, and Self-Assessment Questionnaires. At Visit 2, subjects will be provided with a Post Procedure Cream to use on Days 0, 1, and 2 post treatment. Subjects will continue to use Gentle Foaming Cleanser, Vitamin C Serum (starting on day 3), and Broad-Spectrum Sunscreen SPF 50 as the post-treatment skincare regimen. Subjects will be provided with skincare regimen instructions to be followed throughout the 12-week clinical study. To confirm compliance with usage, each container will be weighed on a scale at every visit and subjects will record topical usage in a daily diary. At Visit 6 (week 12), subjects will return to the clinical site for follow-up clinical evaluations. The same assessments completed at previous visits will be repeated.