Efficacy and Safety of Fractional 1064-nm Picosecond Laser for Facial Skin Tightening

M

Mahidol University

Status

Enrolling

Conditions

Laxity; Skin

Treatments

Device: StarWalker® PQX

Study type

Interventional

Funder types

Other

Identifiers

NCT06231914
Si 981/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

40 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Fractional 1064-nm Picosecond laser
Experimental group
Description:
Fractional 1064-nm Picosecond laser for 3 sessions, at 4-week interval
Treatment:
Device: StarWalker® PQX

Trial contacts and locations

1

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Central trial contact

Supisara Wongdama, MD; Woraphong Manuskiatti, MD

Data sourced from clinicaltrials.gov

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