facial laxity laxity Polynucleotides
Conditions
Interventions
2% Polynucleotide will be injected on the locations of facial ligaments every 1 month for 3 treatment sessions.
Experimental Device
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Eligibility
Sex/Gender
All
Age
30 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Participants aged 30 to 55 years, male or female. 2. Presence of mild to moderate facial laxity. 3. Thai individuals of Asian ethnicity.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding participants. Menstrual history will be reviewed prior to enrollment, and a pregnancy test will be performed if history is unclear. 2. Presence of facial dermatitis, wounds, or active skin infection. 3. History of facial tightening procedures within the past 6 months. 4. Presence of serious underlying medical conditions. 5. History of filler injection, thread lifting, or polynucleotide injection within the past 12 months. 6. History of botulinum toxin injection within the past 6 months. 7. History of keloids or hypertrophic scars. 8. Participants with psychiatric disorders diagnosed by a psychiatrist. 9. Participants who do not permit photography for treatment assessment. 10. History of immunosuppressive medication use, including corticosteroids, chemotherapy, or medications affecting coagulation such as aspirin. 11. Participants with a history of allergic reactions to local anesthetics or polynucleotides.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| volume change baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1, 3, 6, 9 and 12 months after 3rd treatment Quantificare,vector lifting baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1, 3, 6, 9 and 12 months after 3rd treatment Quantificare,Global Aesthetic Improvement Scale Assessment (GAIS) 1 month after 1st treatment, 1 month after 2nd treatment, 1, 3, 6, 9 and 12 months after 3rd treatment Physician assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient assessment 1 month after 1st treatment, 1 month after 2nd treatment, 1, 3, 6, 9 and 12 months after 3rd treatment Quartile scale,Safety baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1, 3, 6, 9 and 12 months after 3rd treatment adverse events | — |
Countries
Thailand
Contacts
Public ContactThanya Techapichetvanich
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Outcome results
None listed