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

NCT ID: NCT07122310

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-26
• Study Completion Date: 2023-06-19

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Picosecond Laser Group

Group Type: EXPERIMENTAL

1064-nm Fractional Picosecond Laser (PicoWay)

Intervention Type: 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 (IPL) Group

Group Type: EXPERIMENTAL

Intense Pulsed Light Therapy (M22 IPL System)

Intervention Type: 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.

Interventions

1064-nm Fractional Picosecond Laser (PicoWay)

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.

Intervention Type: DEVICE

Intense Pulsed Light Therapy (M22 IPL System)

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

（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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yanjun Dan

Resident Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

KY2022-824

Identifier Type: -

Identifier Source: org_study_id