under eye laxity under eye laxity, 1726 nm laser
Conditions
Interventions
Participants receive three monthly laser sessions under controlled parameters using a 1726 nm Laser System
Experimental Device
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Eligibility
Sex/Gender
All
Age
25 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Thai male or female participants aged 25 to 60 years 2. Presence of clinically visible infraorbital skin laxity as assessed by a dermatologist 3. Participants of Thai Asian ethnicity 4. Participants who voluntarily provide informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Pregnant participants, postpartum participants within 1 year, or those who are breastfeeding 2. Participants who are unable or unwilling to provide written informed consent 3. Participants with underlying disorders affecting collagen 4. Participants who have undergone prior lower eyelid surgery or periorbital rejuvenation procedures within 6 months prior to enrollment 5. Participants who have received chemical peeling within 1 month prior to enrollment 6. Participants with a history of abnormal photosensitivity 7. Participants with a history of malignancy, those currently undergoing cancer treatment, or those with skin cancer in the treatment area 8. Participants with a history of immunodeficiency, including HIV infection or AIDS 9. Participants with a history of hypertrophic scars or active dermatologic conditions in the treatment area 10. Participants with wounds or active skin infections in the treatment area 11. Participants with a history of herpes simplex infection or active herpes infection 12. Participants with a history of psychiatric disorders 13. Participants with any condition that, in the investigators opinion, may compromise safety or study participation 14. Participants who do not consent to clinical photography for treatment evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Undereye volume change compared to baseline 1 month after 1st treatment, 1 month after 2nd treatment and 1,3 and 6 months after 3rd treatment VectraH2,Undereye volume change compared to baseline 1 month after 1st treatment, 1 month after 2nd treatment and 1,3 and 6 months after 3rd treatment Lifeviz,skin quality Baseline, 1 month after 1st treatment, 1 month after 2nd treatment and 1,3 and 6 months after 3rd treatment Antera3D,skin pliability/elasticity baseline, 1 month after 1st treatment, 1 month after 2nd treatment and 1,3 and 6 months after 3rd treatment Cutometer,melanin index Baseline, 1 month after 1st treatment, 1 month after 2nd treatment and 1,3 and 6 months after 3rd treatment Mexameter,Erythema index Baseline, 1 month after 1st treatment, 1 month after 2nd treatment and 1,3 and 6 months after 3rd treatment Mexameter,Physician assessment 1 month after 1st treatment, 1 month after 2nd treatment and 1,3 and 6 months after 3rd treatment Blinded physician,Patient subjective assessment 1 month after 1st treatment, 1 month after 2nd treatment and 1,3 and 6 months after 3rd treatment Patient assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Baseline, 1 month after 1st treatment, 1 month after 2nd treatment and 1,3 and 6 months after 3rd treatment Adverse events,Pain 1st treatment 2nd treatment, 3rd treatment Visual analog scale | — |
Countries
Thailand
Contacts
Public ContactWoraphong Manuskiatti
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed