NCT06231914

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

10 months

First QC Date

January 9, 2024

Last Update Submit

January 21, 2024

Conditions

Laxity; Skin

Outcome Measures

Primary Outcomes (4)

  • The changes in wrinkle.

    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.

    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.

    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.

    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 Outcomes (5)

  • The changes in skin texture.

    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.

    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.

    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.

    4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.

  • Adverse events

    4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.

Study Arms (1)

Fractional 1064-nm Picosecond laser

EXPERIMENTAL

Fractional 1064-nm Picosecond laser for 3 sessions, at 4-week interval

Device: StarWalker® PQX

Interventions

StarWalker® PQXDEVICE

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

Fractional 1064-nm Picosecond laser

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 40-55 years
  • BMI \< 25 kg/m2
  • Asian
  • Mild to moderate facial skin laxity using quantitative grading scale (grade 1.5-2.5)

You may not qualify if:

  • Pregnant or lactation
  • Active skin infections
  • History of hypertrophic scars or keloids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Woraphong Manuskiatti, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Woraphong Manuskiatti, MD

CONTACT

6624194333doctorlaser@gmail.com

Supisara Wongdama, MD

CONTACT

66869898613popsupdm@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 9, 2024

First Posted

January 30, 2024

Study Start

December 1, 2023

Primary Completion

October 1, 2024

Study Completion

March 1, 2025

Last Updated

January 30, 2024

Record last verified: 2024-01

Locations

TH(1)