Enhanced Photoaging Reversal Efficacy and Safety of 755nm Alexandrite Picosecond Laser with Diffractive Lens Array (DLA) in Conjunction with Integrated Skin Care for Skin Quality Improvement

Overview

This study evaluates enhanced photoaging reversal efficacy and safety of 755nm alexandrite picosecond laser with diffractive lens array (DLA) in conjunction with integrated skin care for skin quality improvement. It is a single-center, evaluator-blinded, randomized spilt-face design. It is expected to recruit 35 patients whose face with simple pigmentation and photoaging in Dr. Lin's Dermatology Clinic. Each subject will receive both treatment and control procedures according to the side = 1:1 ratio randomly assigned in two spilt-face usage. One spilt-face side is undergoing the treatment procedure with combination skin care products (CE/DD/242), and regular moisturizing product and sunscreen (Phyto Corrective Gel and Advanced Brightening UV Defense SPF50 PA++++). Another spilt-face side is undergoing the control procedure: regular moisturizing product and sunscreen (Phyto Corrective Gel and Advanced Brightening UV Defense SPF50 PA++++). This study includes a total of 3 cycles of treatment (weeks 0-4, 4-8, and 8-12). After each cycle, the effect and satisfaction of the treatment were evaluated once (weeks 4, 8, and 12). For redness/swelling outcome, the self-reported effect will be collected by phone call, or being evaluated by visit within 3 day after additional visits (0w+3d, 4w+3d, and 8w+3d). Generalized linear mixed models will be used to assess whether the patterns of change in the mean response/proportion of each endpoint over time are the same in the treatment procedure and the control procedure. Among the primary endpoint family, either one with statistically significant will meet the study success criteria. The endpoints include (1) Wrinkles (2) Ultraviolet spots (3) Brown spots (4) Texture (5) Red blood vessels (6) Pores (7) Porphyrin (8) Hydration (9) Elasticity (10) Physician's general assessment (12) Subject satisfaction. All statistical analysis will be implement in SAS 9.4 and STATA 18.

Patients undergoing picosecond laser treatment experience skin sensitivity, compromised barrier function, increased water loss, and oxidative stress post-treatment. Inadequate postoperative care prolongs recovery and raises the risk of pigmentation issues or recurrence. Common postoperative care includes antioxidants, moisturizing sunscreen, skin whitening, spot lightening, and barrier repair treatments. Common post-procedure skincare products include (1) CE Serum (an antioxidant serum containing vitamin C, vitamin E, and ferulic acid), (2) DD Serum (a serum containing tranexamic acid, kojic acid, and niacinamide \[vitamin B3\], which helps reduce pigmentation), and (3) Sebum membrane repair cream \[242 cream\] (a newly formulated cream designed to restore the skin barrier function caused by aging). However, standardized post-picosecond laser care protocols are lacking, necessitating more clinical data and experience summaries. This study seeks to assess the effectiveness and satisfaction of combining SkinCeuticals skin-care products (CE/DD/242) with 755nm alexandrite picosecond laser with diffractive lens array (DLA) for facial pigmentation and photoaging. It will be a prospective, single-center, evaluator-blinded, randomized spilt-face design trial. Thirty-five subjects will be recruited and randomly assigned to receive either the combined skincare products (CE/DD/242), and regular moisturizing product and sunscreen (Phyto Corrective Gel and Advanced Brightening UV Defense SPF50 PA++++) (treatment group) or regular moisturizing product and sunscreen alone (control group) following 755nm alexandrite picosecond laser with DLA. The study consists of three treatment cycles over 12 weeks, with assessments conducted at the end of each cycle. Evaluation indicators will be compared at 4, 8, and 12 weeks post-treatment to determine efficacy and satisfaction. Additionally, the redness within 3 day will be collected through phone call or visit at trial site. The study aims to explore the maintenance medical benefits of combining 755nm alexandrite picosecond laser with DLA in conjugated with SkinCeuticals skincare products for facial pigmentation and photoaging.