Patients with facial laxity facial laxity, picosecond laser, 1064 nm laser, pulse duration
Conditions
Interventions
Before each treatment session, topical anesthetic cream will be applied evenly over the entire face and left in place for 45 - 60 minutes.
Participants will receive fractional 1,064-nm picosecond las
Experimental Device
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Eligibility
Sex/Gender
All
Age
40 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Participants aged 40 - 55 years, both male and female 2. Body mass index (BMI) < 25 kg/m2 3. Thai participants of Asian ethnicity 4. Presence of mild to moderate facial skin laxity
Exclusion criteria
Exclusion criteria: 1. Participants who are pregnant, within 3 months postpartum, or currently breastfeeding 2. History of receiving laser, radiofrequency, or other facial tightening treatments within 6 months prior to study enrollment 3. History of botulinum toxin injection to the face within 6 months prior to study enrollment 4. History of dermal filler injection or platelet-rich plasma (PRP) injection to the face within 6 months prior to study enrollment 5. Use of isotretinoin or other retinoids within 6 months prior to study enrollment 6. Presence of other dermatologic conditions or active skin infection at the treatment site Immunocompromised participants 7. History of hypertrophic scar or keloid formation 8. History of smoking or regular alcohol consumption 9. Presence of underlying medical conditions (e.g., diabetes mellitus with impaired collagen formation), immunodeficiency, or any condition deemed by the investigator to pose a safety risk (e.g., epilepsy) 10. Participants who do not provide written informed consent 11. Use of medications affecting coagulation (e.g., NSAIDs, aspirin, or anticoagulants) 12. Participants who do not consent to photography for treatment evaluation 13. Participants unable to comply with sunscreen use after treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lifting Baseline, Immediate after 1st treatment, 2nd treatment, 3rd treatment, 4th treatment, 1,3,6 months follow up Quantificare,Volume change Baseline, Immediate after 1st treatment, 2nd treatment, 3rd treatment, 4th treatment, 1,3,6 months follow up Vectra,Skin texture Baseline, 2nd treatment, 3rd treatment, 4th treatment, 1,3,6 months follow up Antera,Skin firmness and elasticity Baseline, 2nd treatment, 3rd treatment, 4th treatment, 1,3,6 months follow up Cutometer,Melanin index Baseline, 2nd treatment, 3rd treatment, 4th treatment, 1,3,6 months follow up Mexameter,Erythema index Baseline, 2nd treatment, 3rd treatment, 4th treatment, 1,3,6 months follow up Mexameter,Hydration Baseline, 2nd treatment, 3rd treatment, 4th treatment, 1,3,6 months follow up Corneometer,ITA Baseline, 2nd treatment, 3rd treatment, 4th treatment, 1,3,6 months follow up colorimeter,Sebum level Baseline, 2nd treatment, 3rd treatment, 4th treatment, 1,3,6 months follow up Sebumeter | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety 1st treatment, 2nd treatment, 3rd treatment, 4th treatment, 1,3,6 months follow up Adverse event, Patient Improvement scale 1st treatment, 2nd treatment, 3rd treatment, 4th treatment, 1,3,6 months follow up percent improvement,Physician Improvement scale 1st treatment, 2nd treatment, 3rd treatment, 4th treatment, 1,3,6 months follow up percent improvement,Pain score 1st treatment, 2nd treatment, 3rd treatment, 4th treatment Visual analog scale | — |
Countries
Thailand
Contacts
Public ContactYanin Nokdhes
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed