Clinical trial NCT06231914: Efficacy and Safety of Fractional 1064-nm Picosecond Laser for Facial Skin Tightening
Official title: Efficacy and Safety of Fractional 1064-nm Picosecond Laser for Facial Skin Tightening
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laxity; Skin
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The changes in wrinkle.
timeFrame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
measure: The changes in nasolabial fold.
timeFrame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
measure: The changes in skin laxity.
timeFrame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
measure: The changes in skin elasticity.
timeFrame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
Secondary outcomes:
measure: The changes in skin texture.
timeFrame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
measure: The changes in pore volume.
timeFrame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
measure: The change in melanin index and erythema index.
timeFrame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
measure: The change in sebum level.
timeFrame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
measure: Adverse events
timeFrame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Dermatology, Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Woraphong Manuskiatti, MD
role: PRINCIPAL_INVESTIGATOR
References: