Efficacy and Safety of Fractional 1064-nm Picosecond Laser for Facial Skin Tightening
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mahidol University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- The changes in skin elasticity.
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Aged 40-55 years
- •BMI \< 25 kg/m2
- •Mild to moderate facial skin laxity using quantitative grading scale (grade 1.5-2.5)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
The changes in skin elasticity.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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 Outcomes
- 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.)
- Adverse events(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 texture.(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 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 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.)
Investigators
Woraphong Manuskiatti, M.D.
Prof. Dr.
Mahidol University