Skip to content

The study to evaluate the efficacy and safety of Poly-D, L-Lactic Acid injection for Neck Rejuvenation in Thailand

The study to evaluate the efficacy and safety of Poly-D, L-Lactic Acid injection for Neck Rejuvenation in Thailand

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250216010
Enrollment
28
Registered
2025-02-16
Start date
2024-05-28
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

photoaging photoaging, Poly-D, L-Lactic Acid

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

Sponsors

Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Lead Sponsor

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 photodamaged skin on neck

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 neck tightening procedures, including neck-tightening devices or thread lifts, within 6 months before participating in the study. 6. Participants who have received dermal filler injections in the neck area within 6 months before participating in the study. 7. Participants who have received platelet-rich plasma (PRP) injections in the neck area within 6 months before participating in the study. 8. Participants who have received botulinum toxin injections in the neck area within 6 months before participating in the study. 9. Participants who have undergone collagen-stimulating laser treatments in the neck 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

MeasureTime 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, Physician

Secondary

MeasureTime frame
Safety baseline, 1 month after 1st treatment, 1 month after 2nd treatment and 1, 3, 6, 9and 12 months after 3rd treatment, Adverse event,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

rungsima.wan@mahidol.ac.th024197000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026