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

Last updated: January 21, 2024
Sponsor: Mahidol University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

StarWalker® PQX

Clinical Study ID

NCT06231914
Si 981/2023
  • Ages 40-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Pregnant or lactation
  • Subjects who have been treated with any kind of energy-based device 6 months prior tothe inclusion
  • Subjects who have been injected with botulinum toxin, filler, or platelet-rich plasmaon their faces 6 months prior to the inclusion
  • Active skin infections
  • History of hypertrophic scars or keloids

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: StarWalker® PQX
Phase:
Study Start date:
December 01, 2023
Estimated Completion Date:
March 01, 2025

Study 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.

Connect with a study center

  • Department of Dermatology, Siriraj Hospital, Mahidol University

    Bangkok, 10700
    Thailand

    Active - Recruiting

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