Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06231914
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2024-01-09
Brief Title:
Efficacy and Safety of Fractional 1064-nm Picosecond Laser for Facial Skin Tightening
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
Efficacy and Safety of Fractional 1064-nm Picosecond Laser for Facial Skin Tightening
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 kgm2 and have mild to moderate facial laxity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None