photodamaged skin Poly-D,L-lactic acid (PDLLA), photodamaged skin, facial rejuvenation
Conditions
Interventions
Patients were treated with Poly-D, L-Lactic Acid 3 sessions every 4 weeks. Then they were instructed to follow up at 1, 3, 6, 9 and 12 months after last treatment.
Experimental Drug
Poly-D,L-lactic acid (PDLLA)
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Male and female age 20-60 years old 2. Have facial photodamaged skin
Exclusion criteria
Exclusion criteria: 1. Pregnant women or those who are breastfeeding. 2. Participants with a history of platelet disorders, abnormal blood coagulation, anemia, liver disease, cancer, or autoimmune deficiency diseases. 3. Participants who smoke or have a history of heavy alcohol consumption 4. Participants with a history of taking blood coagulation-affecting medications such as aspirin or anticoagulants. 5. Participants who have undergone facial tightening procedures, including facial tightening devices or thread lifts, within 6 months before participating in the study. 6. Participants who have received dermal filler injections in the face area within 6 months before participating in the study. 7. Participants who have received platelet-rich plasma (PRP) injections in the face area within 6 months before participating in the study. 8. Participants who have received botulinum toxin injections in the face area within 6 months before participating in the study. 9. Participants who have undergone collagen-stimulating laser treatments in the face area, such as Picosecond laser, Erbium:YAG laser, Fractora, or Laser E-Matrix, within 6 months before participating in the study. 10. Participants with a history of keloid scars. 11. Participants diagnosed with psychiatric disorders by a psychiatrist. 12. Participants with autoimmune diseases. 13. Participants taking immunosuppressive drugs. 14. Participants with a history of severe allergic reactions (anaphylaxis). 15. Participants with a history of starch allergies, such as corn, sugarcane, potatoes, or beets. 16. Participants who have taken vitamin E, fish oil, etc., within 2 weeks before participating in the study. 17. Participants who do not consent to having their photos taken for treatment evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wrinkles indentation baseline, 1 month after 1st treatment, 1 month after 2nd treatment and 1, 3, 6, 9and 12 months after 3rd treatment, Antera,Texture baseline, 1 month after 1st treatment, 1 month after 2nd treatment and 1, 3, 6, 9and 12 months after 3rd treatment, Antera,Physicians' improvement scale baseline, 1 month after 1st treatment, 1 month after 2nd treatment and 1, 3, 6, 9and 12 months after 3rd treatment, Physicians | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety baseline, 1 month after 1st treatment, 1 month after 2nd treatment and 1, 3, 6, 9and 12 months after 3rd treatment, Adverse events, skin firmness baseline, 1 month after 1st treatment, 1 month after 2nd treatment and 1, 3, 6, 9and 12 months after 3rd treatment, Cutometer,melanin index baseline, 1 month after 1st treatment, 1 month after 2nd treatment and 1, 3, 6, 9and 12 months after 3rd treatment, Mexameter,erythema index baseline, 1 month after 1st treatment, 1 month after 2nd treatment and 1, 3, 6, 9and 12 months after 3rd treatment, Mexameter,hydration baseline, 1 month after 1st treatment, 1 month after 2nd treatment and 1, 3, 6, 9and 12 months after 3rd treatment, Corneometer, Individual typology angle (ITA) baseline, 1 month after 1st treatment, 1 month after 2nd treatment and 1, 3, 6, 9and 12 months after 3rd treatment, Colorimeter | — |
Countries
Thailand
Contacts
Public ContactRungsima Wanitphakdeedecha
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed