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

NCT07122310 | Completed

• 1 other identifier: KY2022-824
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Skin Aging; Skin Rejuvenation; Photoaging

Keywords

Skin Rejuvenation; Picosecond laser; Intense pulsed light

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (7)

• Blinded GSP scoring

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

• Regional Fine Line and Dyschromia Grading by Dermatologists

  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)

• Quantitative Assessment of Skin Roughness Using C-Cube Imaging System

  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)

• Quantitative Skin Pigmentation and Erythema Assessment Using SkinColorCatch

  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)

• Transepidermal Water Loss (TEWL) Measurement Using Delfin Vapometer

  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)

Study Arms (2)

Picosecond Laser Group

EXPERIMENTAL

Device: 1064-nm Fractional Picosecond Laser (PicoWay)

Intense Pulsed Light (IPL) Group

EXPERIMENTAL

Device: Intense Pulsed Light Therapy (M22 IPL System)

Interventions

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.

Picosecond Laser Group

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.

Intense Pulsed Light (IPL) Group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• （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.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Related Publications (1)

• 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 Jan 4. doi: 10.1002/lsm.70094. Online ahead of print.

  PMID: 41485124 DERIVED

MeSH Terms

Interventions

Intense Pulsed Light Therapy

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 14, 2025
• Study Start: September 26, 2021
• Primary Completion: January 8, 2023
• Study Completion: June 19, 2023
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)