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

NCT ID: NCT06231914

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-03-01

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.

Conditions

Laxity; Skin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fractional 1064-nm Picosecond laser

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

Group Type: EXPERIMENTAL

StarWalker® PQX

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Woraphong Manuskiatti, M.D.

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Woraphong Manuskiatti, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Department of Dermatology, Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Woraphong Manuskiatti, MD

Role: CONTACT

doctorlaser@gmail.com

6624194333

Supisara Wongdama, MD

Role: CONTACT

popsupdm@gmail.com

66869898613

Facility Contacts

Woraphong Manuskiatti, M.D.

Role: primary

doctorlaser@gmail.com

66869898613

Other Identifiers

Si 981/2023

Identifier Type: -

Identifier Source: org_study_id