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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fractional 1064-nm Picosecond laser | Experimental | Fractional 1064-nm Picosecond laser for 3 sessions, at 4-week interval |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StarWalker® PQX | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The changes in wrinkle. | The changes in indentation of wrinkle using Antera (mm3) | 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. | The changes in nasolabial fold using Quantificare (mm3) | 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. | The changes in skin laxity using Quantificare (mm3) | 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. | The changes in skin elasticity (R0, R2, R5) using Cutometer (%) | 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| The changes in skin texture. | The measurement will be done using Antera (mm3) | 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 pore volume. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Woraphong Manuskiatti, MD | Contact | 6624194333 | doctorlaser@gmail.com | |
| Supisara Wongdama, MD | Contact | 66869898613 | popsupdm@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Woraphong Manuskiatti, MD | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Siriraj Hospital, Mahidol University | Recruiting | Bangkok | 10700 | Thailand |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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The measurement will be done using Antera (mm3)
| 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. | The measurement of bioengineering assessment including melanin index and erythema index using Mexameter (%) | 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. | The change in sebum production using Sebumeter (%) | 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment. |
| Adverse events | Adverse events that occurred during the study protocol | 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment. |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |