Skip to main content
OpenTrials
Completed

NCT Number: NCT06818630

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bright Skin Clinic

Hsinchu, 300, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects 25-65 years of age on the date of informed consent
  • Fitzpatrick skin type II-V with pigmentation and photoaging on both sides of the face
  • The severity of pigmentation and photoaging on both sides of the face is the same.
  • Willing to receive picosecond laser treatment.
  • Willing to follow the research requirements and cooperate with the process for follow-up visits.
  • Subjects able to understand the written informed consent and willing to subject as evidenced by signing the informed consent

Exclusion criteria

  • Women who are pregnant, breastfeeding, or planning to conceive within one year.
  • Subjects with active facial melasma.
  • Those with a history of skin pigmentation disorders, such as pigmentation induced by hormonal factors (pregnancy, oral contraceptives).
  • Subjects with autoimmune diseases, endocrine disorders, or liver diseases that lead to changes in skin color.
  • Subjects who have used skin whitening agents, steroids, or photosensitive drugs within the past three months.
  • Subjects who have undergone laser treatment within the past three months.
  • Those who have contraindications to picosecond laser or the CE/DD/242 products, or are allergic to the ingredients in the skincare combination products.
  • Subjects with facial infections or inflammation.
  • Those planning to use other medications affecting skin color during the study or in-tending to undergo other laser treatments or sunbathing.
  • Subjects currently participating in other clinical trials.
  • Subjects deemed unsuitable for participation in this study after evaluation by the researchers.

Treatment and study plan

SkinCeuticals combination skin care products

Other
  • CE Ferulic Serum,
  • Discoloration Defense (3% Tranexamic Acid),
  • Triple Lipid Restore 2:4:2

Regular skin care procedure

Other
  • Regular moisturizing product (Phyto Corrective Gel),
  • sunscreen (Advanced Brightening UV Defense SPF50 PA++++)

Primary outcomes

  1. The change of wrinkles, ultraviolet spots, brown spots, texture, pores, porphyrin, redness, blood vessels, hydration

    Time frame: Weeks 0, 4, 8, and 12

    The scores for wrinkles, ultraviolet spots, brown spots, texture, pores, porphyrin, redness, blood vessels, and hydration are measured using the VISIA skin analysis system (Canfield Scientific, USA).

  2. Improvement in hydration and elasticity

    Time frame: Weeks 0, 4, 8, and 12

    The score of hydration and elasticity are measured by Focuskin.

  3. Physician Assessments

    Time frame: Weeks 0, 4, 8, and 12

    The assessments by physicians based on digital photographs of the subjects' faces, scored from 0 to 4.

  4. Participant satisfaction

    Time frame: Weeks 4, 8, and 12

    A questionnaire will be used to assess the overall satisfaction of the subjects regarding the skin care products. The satisfaction levels are classified as: Very Satisfied, Satisfied, Unsatisfied, and Very Unsatisfied.

Sponsors and collaborators

Lead sponsor

L'Oréal Taiwan Co., Ltd

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 10, 2025
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.