participant with photoaging at eye and lip polynucleotide, eye rejuvenation, lip rejuvenation, sharp needle injection, cannula injection
Conditions
Interventions
The random side was injected with sharp needle at periorbital area,The random side was injected with cannula needle at periorbital area
Active Comparator Device,Active Comparator Device
sharp needle injection,cannula injection
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Eligibility
Sex/Gender
All
Age
30 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Age from 30-55 years, both male and female. 2. Assessed by a specialist dermatologic surgeon with the Glogau classification of photoaging indicating a moderate level or higher, specifically around the eyes and mouth. 3. Thai of Asian descent. 4. Participants who consent to join the project voluntarily and agree to receive injections of polynucleotides with the quantity and at the positions specified in the research protocol. 5. Participants in this project are not participating in another treatment study.
Exclusion criteria
Exclusion criteria: 1. Pregnant women and those breastfeeding 2. Participants with inflammatory skin rashes (dermatitis), wounds, or infected skin on the face. 3. Participants who have had facial and/or neck lifting procedures within 6 months prior to joining the research project. 4. Participants with severe chronic illnesses such as advanced-stage cancer requiring radiation or chemotherapy, or kidney disease requiring dialysis. 5. Participants who have had injections of fillers, thread lifting, or polynucleotides within 12 months before joining the research project. 6. Participants who have had botulinum toxin injections within 6 months before joining the research project. 7. Participants with hypertrophic scars. 8. Participants diagnosed with a mental disorder by a psychiatrist. 9. Participants who do not consent to having photographs taken for treatment assessment. 10. Participants with a history of taking immunosuppressive medications such as steroids, undergoing chemotherapy, or taking medications that affect blood clotting, such as aspirin. 11. Participants with a history of allergy to local anesthetics or polynucleotides. 12. Participants with a history of blood clotting disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average Wrinkle baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after complete treatment, 3- , 6- , 9- and 12- months after complete treatment antera,Average Texture baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after complete treatment, 3- , 6- , 9- and 12- months after complete treatment antera,Patient improvement score baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after complete treatment, 3- , 6- , 9- and 12- months after complete treatment GAIS | — |
Secondary
| Measure | Time frame |
|---|---|
| volume change baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after complete treatment, 3- , 6- , 9- and 12- months after complete treatment vectra,volume change baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after complete treatment, 3- , 6- , 9- and 12- months after complete treatment Quantificare,physician assessment baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after complete treatment, 3- , 6- , 9- and 12- months after complete treatment clinical photos,adverse event baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after complete treatment, 3- , 6- , 9- and 12- months after complete treatment note,skin elasticity baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after complete treatment, 3- , 6- , 9- and 12- months after complete treatment cutometer,melanin baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after complete treatment, 3- , 6- , 9- and 12- months after complete treatment mexameter,erythema baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after complete treatment, 3- , 6- , 9- and 12- months after complete treatment mexameter,pain score baseline, 1 month after 1st treatment, 1 month after 2nd treatment visual analog score | — |
Countries
Thailand
Contacts
Public ContactRungsima Wanitphakdeedecha
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed