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Skin AgingNCT07122310

Comparative Study of a 1064-nm Fractional Picosecond Laser Versus IPL in Facial Rejuvenation

A study testing 1064-nm Fractional Picosecond Laser (PicoWay) and Intense Pulsed Light Therapy (M22 IPL System) in people with Skin Aging and Skin Rejuvenation, run by Huashan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-center, prospective, randomized controlled trial conducted at Huashan Hospital, Fudan University. The purpose of this study is to compare the effectiveness and safety of two non-invasive treatment options-1064-nm fractional picosecond laser and intense pulsed light (IPL)-for facial rejuvenation. Read more about this study

Who is it for?
Ages 30 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Skin Aging, Skin Rejuvenation, Photoaging
What is being tested?
1064-nm Fractional Picosecond Laser (PicoWay) and Intense Pulsed Light Therapy (M22 IPL System)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteChina
Study dates
26 Sep 2021to 19 Jun 2023
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 30 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • （1）Individuals aged 30-60 years with a GSP score of 1-4;（2）Fitzpatrick skin phototypes III-IV;（3）Written informed consent obtained.

Who cannot join

  • （1）Pregnant or lactating women;（2）Patients with severe systemic diseases;（3）Individuals with coagulation dysfunction;（4）Patients with mental disorders;（5）Photosensitive individuals;（6）Individuals with infections at the treatment site;（7）Individuals who have used photosensitive drugs within 4 weeks;（8）Individuals who have received other cosmetic treatments such as laser, intense pulsed light (IPL), radiofrequency, chemical peels (e.g., glycolic acid), fillers, etc., within 6 months;（9）Individuals with a personal or family history of keloids;（10）Individuals with a personal or family history of cutaneous squamous cell carcinoma or melanoma;（11）Individuals with a personal or family history of vitiligo;（12）Individuals with a history of intense sun exposure or ultraviolet (UV) radiation within 1 month.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040

Other trials in China

About this study

Official title: A Prospective, Randomized, Comparative Study of a 1064-nm Fractional Picosecond Laser Versus Intense Pulsed Light in Facial Rejuvenation

This is a single-center, prospective, randomized controlled trial conducted at Huashan Hospital, Fudan University. The purpose of this study is to compare the effectiveness and safety of two non-invasive treatment options-1064-nm fractional picosecond laser and intense pulsed light (IPL)-for facial rejuvenation. A total of 38 participants seeking cosmetic improvement were randomly assigned to receive three sessions of either picosecond laser or IPL treatment at 4-6 week intervals.

Each participant was monitored throughout the treatment period and at one month after the final session. The study assessed improvements in skin texture, pigmentation, and wrinkles, as well as treatment-related side effects. All participants provided informed consent and received standardized post-treatment care instructions, including moisturization and sun protection. The results of this study may help guide non-surgical treatment options for skin aging.

Being tested
1064-nm Fractional Picosecond Laser (PicoWay), Intense Pulsed Light Therapy (M22 IPL System)
Keywords
Skin Rejuvenation, Picosecond laser, Intense pulsed light

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1064-nm Fractional Picosecond Laser (PicoWay)Device

    Intervention Name: 1064-nm Fractional Picosecond Laser (PicoWay) Participants in this group received full-face treatments using a PicoWay® laser system (Candela, Wayland, MA, USA) equipped with a 1064-nm RESOLVE fractional handpiece. Treatment parameters included a 6 mm spot size, 6 Hz repetition rate, 450 ps pulse duration, and energy settings ranging from 1.5 to 2.3 mJ per microbeam. Each session consisted of 2-3 passes (approximately 2000-4000 pulses), adjusted based on individual response. Three sessions were delivered at 4-6-week intervals. Cold compresses were applied for 20 minutes immediately post-treatment.

  • Intense Pulsed Light Therapy (M22 IPL System)Device

    Intervention Name: Intense Pulsed Light Therapy (M22 IPL System)

    Intervention Description:

    Participants in this group underwent full-face treatments using an M22® IPL system (Lumenis, Yokneam, Israel) with a 560 nm cutoff filter. Treatment parameters included a pulse duration of 3.5-4 ms, pulse delay of 25-30 ms, and fluence of 12-18 J/cm², adjusted based on individual response. Each treatment involved approximately 40-60 pulses. Three sessions were performed at 4-6-week intervals. A layer of medical ultrasound gel was applied before treatment and maintained for 15-20 minutes post-treatment.

Study groups in NCT07122310
Study groupRoleWhat they receive
Picosecond Laser GroupExperimentalNot described
Receives: Device: 1064-nm Fractional Picosecond Laser (PicoWay)
Intense Pulsed Light (IPL) GroupExperimentalNot described
Receives: Device: Intense Pulsed Light Therapy (M22 IPL System)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blinded GSP (Global Score for Photoaging) assessment by two dermatologists

    Global skin photoaging score assessed by blinded dermatologists using the Global Skin Photoaging (GSP) Scale. Scale range: 0-4, where higher scores indicate more severe photoaging.

    Measured: 1 month after third treatment (approximately 12-16 weeks after baseline)

Secondary outcomes (7)

  1. Blinded GSP scoring

    Global skin photoaging score assessed by blinded dermatologists using the Global Skin Photoaging (GSP) Scale. Scale range: 0-4, where higher scores indicate more severe photoaging.

    The scoring criteria are defined as follows:

    0: Smooth skin without visible wrinkles or pigmentary heterogeneity in cheeks, forehead, or perioral regions

    1. Discrete focus of textural roughness, dyschromia, or fine lines in one facial region (cheeks/forehead/perioral)
    2. Two distinct areas demonstrating textural roughness, dyschromia, or fine lines; OR concurrent manifestations (roughness + dyschromia + wrinkles) in one region
    3. Three affected areas; OR concurrent manifestations in two regions
    4. Photodamage exceeding grade 3 criteria

    Measured: baseline (before first treatment), before second treatment (approximately 4-6 weeks after baseline), before third treatment (approximately 8-12 weeks after baseline)

  2. Regional Fine Line and Dyschromia Grading by Dermatologists

    Fine lines graded on the Modified Fine Line Improvement Scale (-1 to 4: -1=worsening, 0=no change, 1=1-25% improvement, 2=25-50%, 3=50-75%, 4=75-100%; higher scores = greater improvement).

    Dyschromia graded on the Modified Dyschromia Improvement Scale (-1 to 4: -1=increased severity, 0=no change, 1=1-25% reduction, 2=25-50% reduction, 3=50-75% reduction, 4=75-99% reduction; higher scores = greater improvement).

    Measured: before second treatment (approximately 4-6 weeks after baseline), before third treatment (approximately 8-12 weeks after baseline), and 1 month after third treatment (approximately 12-16 weeks after baseline)

  3. Quantitative Assessment of Skin Roughness Using C-Cube Imaging System

    Skin surface roughness will be objectively quantified using the C-Cube high-resolution imaging system (Pixience, Toulouse, France). Standardized images will be captured from predefined facial regions (e.g., cheek or forehead) under consistent lighting and positioning conditions. Roughness values will be automatically calculated by the system's built-in analysis software. Measurements will be performed at baseline, second, third, and fourth follow-up visits to monitor treatment-induced changes.

    Measured: baseline (before first treatment), before second treatment (~4-6 weeks after baseline), before third treatment (~8-12 weeks), and 1 month after third treatment (~12-16 weeks)

  4. Quantitative Skin Pigmentation and Erythema Assessment Using SkinColorCatch

    Objective colorimetric measurements will be performed using the Delfin SkinColorCatch® device to quantify skin pigmentation and erythema in predefined facial regions. The following parameters will be recorded at each time point: Melanin Index (MI), L* value (lightness), and Erythema Index (EI). Measurements will be obtained under standardized ambient lighting and positioning conditions at baseline, second, third, and fourth follow-up visits.

    Measured: baseline (before first treatment), before second treatment (~4-6 weeks after baseline), before third treatment (~8-12 weeks), and 1 month after third treatment (~12-16 weeks)

  5. Transepidermal Water Loss (TEWL) Measurement Using Delfin Vapometer

    Skin barrier function will be assessed by measuring transepidermal water loss (TEWL) using the Delfin Vapometer® device. Measurements will be taken at standardized facial sites under controlled environmental conditions (temperature and humidity) following device guidelines. TEWL values will be recorded at baseline and at the second, third, and fourth follow-up visits to evaluate changes in skin barrier integrity over the treatment course.

    Measured: baseline (before first treatment), before second treatment (~4-6 weeks after baseline), before third treatment (~8-12 weeks), and 1 month after third treatment (~12-16 weeks)

  6. Standardized VISIA Photographic Documentation

    Standardized facial photographs will be captured using the VISIA Complexion Analysis System (Canfield Scientific, USA) at each time point to document changes in skin appearance. The system will provide consistent image capture under controlled lighting and positioning conditions. VISIA documentation will support visual assessment of treatment-related changes in texture, pores, pigmentation, and overall skin condition. Images will be used for qualitative reference and supplemental analysis by blinded evaluators.

    Measured: baseline (before first treatment), before second treatment (~4-6 weeks after baseline), before third treatment (~8-12 weeks), and 1 month after third treatment (~12-16 weeks)

  7. Incidence of Adverse Events

    Adverse events (AEs) including erythema, edema, hyperpigmentation, hypopigmentation, burning sensation, pain, and scarring will be recorded following each treatment session and at each follow-up visit.

    Measured: before second treatment (~4-6 weeks after baseline), before third treatment (~8-12 weeks), and 1 month after third treatment (~12-16 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2025
  2. Study start26 Sep 2021
  3. Primary completion8 Jan 2023
  4. Study completion19 Jun 2023

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were randomly assigned in a 1:1 ratio to receive either a 1064-nm fractional picosecond laser treatment or an intense pulsed light (IPL) treatment. Each group received three treatment sessions at 4-6 week intervals.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07122310
Sponsor's protocol ID
KY2022-824
Status last verified
Aug 2025
First submitted
5 Aug 2025
Last updated
14 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared because this single-center study does not have a formal data sharing infrastructure, and participants did not provide consent for public data sharing. Aggregated results may be reported in publications or upon reasonable request.

Publications

  • Zhang J, Wu C, Liu Y, Yan F, Chen Q, Zhu Y, Xiang LF, Ren J. Comparative Study of a 1064 nm Fractional Picosecond Laser Versus Intense Pulsed Light in Facial Rejuvenation: A Prospective Randomized Trial. Lasers Surg Med. 2026 Mar;58(3):184-193. doi: 10.1002/lsm.70094. Epub 2026 Jan 4.

    PubMed 41485124

Questions about this trial

What is this clinical trial studying?

A study testing 1064-nm Fractional Picosecond Laser (PicoWay) and Intense Pulsed Light Therapy (M22 IPL System) in people with Skin Aging and Skin Rejuvenation, run by Huashan Hospital at 1 site in China.

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 1 inclusion and 1 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 14 Aug 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 China. 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?

Blinded GSP (Global Score for Photoaging) assessment by two dermatologists (time frame: 1 month after third treatment (approximately 12-16 weeks after baseline)). 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 NCT07122310, 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 14 Aug 2025.

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