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

NCT06818630 | Completed

• 1 other identifier: IRB-24-044-A2_LOREAL(CE/DD/24)
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Quality Improvement

Keywords

picosecond laser; CE/DD/242

Outcome Measures

Primary Outcomes (4)

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

  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).

  Weeks 0, 4, 8, and 12

• Improvement in hydration and elasticity

  The score of hydration and elasticity are measured by Focuskin.

  Weeks 0, 4, 8, and 12

• Physician Assessments

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

  Weeks 0, 4, 8, and 12

• Participant satisfaction

  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.

  Weeks 4, 8, and 12

Study Arms (2)

Experimental side

EXPERIMENTAL

The experimental side receiving a combination treatment of SkinCeuticals skincare products, regular moisturizing product, and sunscreen on one half of the face, following 755nm alexandrite picosecond laser with DLA.

Other: SkinCeuticals combination skin care products; Other: Regular skin care procedure

Control side

EXPERIMENTAL

The control side receiving the regular moisturizing product and sunscreen on the corresponding half of the face, following 755nm alexandrite picosecond laser with DLA.

Other: Regular skin care procedure

Interventions

SkinCeuticals combination skin care products OTHER

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

Experimental side

Regular skin care procedure OTHER

1. Regular moisturizing product (Phyto Corrective Gel), 2. sunscreen (Advanced Brightening UV Defense SPF50 PA++++)

Control side; Experimental side

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• L'Oréal Taiwan Co., Ltd: lead

Study Sites (1)

Bright Skin Clinic

Hsinchu, 300, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 10, 2025
• Study Start: July 29, 2024
• Primary Completion: October 29, 2024
• Study Completion: January 23, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)