Comparative Study of a 1064-nm Fractional Picosecond Laser Versus IPL in Facial Rejuvenation
- Conditions
- Skin AgingSkin RejuvenationPhotoaging
- Registration Number
- NCT07122310
- Lead Sponsor
- Huashan Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 38
（1）Individuals aged 30-60 years with a GSP score of 1-4;（2）Fitzpatrick skin phototypes III-IV;（3）Written informed consent obtained.
（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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Blinded GSP (Global Score for Photoaging) assessment by two dermatologists 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 Outcome Measures
Name Time Method 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) 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 criteriaQuantitative 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) 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.
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) 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.
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) 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.
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) 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.
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) 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).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) 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.
Trial Locations
- Locations (1)
Huashan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Huashan Hospital, Fudan University🇨🇳Shanghai, Shanghai, China