A Prospective, Randomized, Comparative Study of a 1064-nm Fractional Picosecond Laser Versus Intense Pulsed Light in Facial Rejuvenation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Huashan Hospital
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Blinded GSP (Global Score for Photoaging) assessment by two dermatologists
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Picosecond Laser Group
Intervention: 1064-nm Fractional Picosecond Laser (PicoWay) (Device)
Intense Pulsed Light (IPL) Group
Intervention: Intense Pulsed Light Therapy (M22 IPL System) (Device)
Outcomes
Primary Outcomes
Blinded GSP (Global Score for Photoaging) assessment by two dermatologists
Time Frame: 1 month after third treatment (approximately 12-16 weeks after baseline)
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.
Secondary Outcomes
- 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))
- 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))
- Standardized VISIA Photographic Documentation(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))
- Incidence of Adverse Events(before second treatment (~4-6 weeks after baseline), before third treatment (~8-12 weeks), and 1 month after third treatment (~12-16 weeks))
- 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))
Investigators
Yanjun Dan
Resident Physician
Huashan Hospital