Skin Quality ImprovementNCT06818630
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
A study testing SkinCeuticals combination skin care products and Regular skin care procedure in people with Skin Quality Improvement, run by L'Oréal Taiwan Co., Ltd at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Skin Quality Improvement
- What is being tested?
- SkinCeuticals combination skin care products and Regular skin care procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Jul 2024to 23 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Skin Quality Improvement
- Being tested
- SkinCeuticals combination skin care products, Regular skin care procedure
- Keywords
- picosecond laser, CE/DD/242
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SkinCeuticals combination skin care productsOther
- CE Ferulic Serum,
- Discoloration Defense (3% Tranexamic Acid),
- Triple Lipid Restore 2:4:2
Regular skin care procedureOther
- Regular moisturizing product (Phyto Corrective Gel),
- sunscreen (Advanced Brightening UV Defense SPF50 PA++++)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Regular skin care procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Weeks 0, 4, 8, and 12
Improvement in hydration and elasticity
The score of hydration and elasticity are measured by Focuskin.
Measured: 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.
Measured: 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.
Measured: Weeks 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start29 Jul 2024
- Primary completion29 Oct 2024
- Study completion23 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin Quality ImprovementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- L'Oréal Taiwan Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818630
- Sponsor's protocol ID
- IRB-24-044-A2_LOREAL(CE/DD/24)
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin LC, Yu YT, Hsiao HJ, Lai YH, Pan CT, Wang YJ. Integrated Topical Skincare Enhances Picosecond Laser Treatment Outcomes for Photoaging: A Prospective Split-Face Trial. Aesthetic Plast Surg. 2026 Jul 23. doi: 10.1007/s00266-026-05993-y. Online ahead of print.
PubMed 42493591
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06818630
- Acronym / sponsor ID
- IRB-24-044-A2_LOREAL(CE/DD/24)
- Conditions
- Skin Quality Improvement
- Keywords
- picosecond laser, CE/DD/242
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- L'Oréal Taiwan Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental side | Experimental | Other: SkinCeuticals combination skin care products, Other: Regular skin care procedureThe 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. |
| Control side | Experimental | Other: Regular skin care procedureThe control side receiving the regular moisturizing product and sunscreen on the corresponding half of the face, following 755nm alexandrite picosecond laser with DLA. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SkinCeuticals combination skin care products1. CE Ferulic Serum, 2. Discoloration Defense (3% Tranexamic Acid), 3. Triple Lipid Restore 2:4:2 | Other | Experimental side |
| Regular skin care procedure1. Regular moisturizing product (Phyto Corrective Gel), 2. sunscreen (Advanced Brightening UV Defense SPF50 PA++++) | Other | Control side, Experimental side |
Primary outcome
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).
Improvement in hydration and elasticity
Time frame: Weeks 0, 4, 8, and 12
The score of hydration and elasticity are measured by Focuskin.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Derived from this study: PubMed 42493591Lin LC, Yu YT, Hsiao HJ, Lai YH, Pan CT, Wang YJ. Integrated Topical Skincare Enhances Picosecond Laser Treatment Outcomes for Photoaging: A Prospective Split-Face Trial. Aesthetic Plast Surg. 2026 Jul 23. doi: 10.1007/s00266-026-05993-y. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SkinCeuticals combination skin care products and Regular skin care procedure in people with Skin Quality Improvement, run by L'Oréal Taiwan Co., Ltd at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of wrinkles, ultraviolet spots, brown spots, texture, pores, porphyrin, redness, blood vessels, hydration (time frame: Weeks 0, 4, 8, and 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06818630, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.