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

Laxity; Skin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06231914
• Other study ID #: Si 981/2023
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: January 2024
• Source: Mahidol University
• Contact: Woraphong Manuskiatti, MD
• Phone: 6624194333
• Email: doctorlaser[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cutis Laxa
• Laxity; Skin

Intervention

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

Locations

Country	Name	City	State
Thailand	Department of Dermatology, Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	The changes in skin texture.	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.
Secondary	The changes in pore volume.	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.
Secondary	The change in melanin index and erythema index.	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.
Secondary	The change in sebum level.	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.
Secondary	Adverse events	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.