Efficacy and Safety of Fractional 1064-nm Picosecond Laser for Facial Skin Tightening
- Conditions
- Laxity; Skin
- Interventions
- Device: StarWalker® PQX
- Registration Number
- NCT06231914
- Lead Sponsor
- Mahidol University
- Brief Summary
The goal of this clinical trial is to learn the efficacy and safety of fractional 1064-nm picosecond laser for facial skin tightening. The main questions it aims to answer are:
* Efficacy of fractional 1064-nm picosecond laser for facial skin efficacy including the changes in wrinkle, nasolabial fold, skin laxity, and skin elasticity
* The changes in texture and pore volume using Antera
* The changes in bioengineering assessment: melanin index, erythema index, sebum level
* Adverse events Participants will be treated with 3 sessions of fractional 1064-nm picosecond laser (full face 4 passes, vector lines 4 passes), spaced 4 weeks apart. Follow-up visits 1, 3, and 6 months after the last treatments.
- Detailed Description
The efficacy and safety of fractional 1064-nm picosecond laser for facial skin tightening in participants aged 40 to 55 years, BMI \< 25 kg/m2, and have mild to moderate facial laxity.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Aged 40-55 years
- BMI < 25 kg/m2
- Asian
- Mild to moderate facial skin laxity using quantitative grading scale (grade 1.5-2.5)
- Pregnant or lactation
- Subjects who have been treated with any kind of energy-based device 6 months prior to the inclusion
- Subjects who have been injected with botulinum toxin, filler, or platelet-rich plasma on their faces 6 months prior to the inclusion
- Active skin infections
- History of hypertrophic scars or keloids
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fractional 1064-nm Picosecond laser StarWalker® PQX Fractional 1064-nm Picosecond laser for 3 sessions, at 4-week interval
- Primary Outcome Measures
Name Time Method The changes in skin elasticity. 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment. The changes in skin elasticity (R0, R2, R5) using Cutometer (%)
The changes in wrinkle. 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment. The changes in indentation of wrinkle using Antera (mm3)
The changes in nasolabial fold. 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment. The changes in nasolabial fold using Quantificare (mm3)
The changes in skin laxity. 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment. The changes in skin laxity using Quantificare (mm3)
- Secondary Outcome Measures
Name Time Method The changes in pore volume. 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment. The measurement will be done using Antera (mm3)
Adverse events 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment. Adverse events that occurred during the study protocol
The changes in skin texture. 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment. The measurement will be done using Antera (mm3)
The change in melanin index and erythema index. 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment. The measurement of bioengineering assessment including melanin index and erythema index using Mexameter (%)
The change in sebum level. 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment. The change in sebum production using Sebumeter (%)
Trial Locations
- Locations (1)
Department of Dermatology, Siriraj Hospital, Mahidol University
🇹🇭Bangkok, Thailand