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

January 21, 2024 updated by: Woraphong Manuskiatti, M.D., Mahidol University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Department of Dermatology, Siriraj Hospital, Mahidol University
        • Contact:
        • Principal Investigator:
          • Woraphong Manuskiatti, M.D.
        • Sub-Investigator:
          • Supisara Wongdama, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fractional 1064-nm Picosecond laser
Fractional 1064-nm Picosecond laser for 3 sessions, at 4-week interval
Device: StarWalker® PQX
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes in wrinkle.
Time Frame: 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 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.
Time Frame: 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 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.
Time Frame: 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 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.
Time Frame: 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 (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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes in skin texture.
Time Frame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
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.
Time Frame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
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.
Time Frame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
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.
Time Frame: 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 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
Time Frame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Woraphong Manuskiatti, MD, Mahidol university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

January 9, 2024

First Submitted That Met QC Criteria

January 21, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 21, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si 981/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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