Laxity; Skin
Conditions
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.
Interventions
DEVICEStarWalker® PQX
Third-generation ASP-powered technology for ultra performance: Highest pico power & energy, shortest pico pulse width, wide range of laser wavelengths, exceptional spot size capabilities, largest fluence spectrum for flat-top handpieces
Sponsors
Mahidol University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 40-55 years * BMI \< 25 kg/m2 * Asian * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 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) |
| 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 (%) |
Countries
Thailand
Contacts
Primary ContactWoraphong Manuskiatti, MD
Backup ContactSupisara Wongdama, MD
Outcome results
None listed