participants with sign of photoaging at the neck area Polynucleotide, cannula injection, sharp needle injection, neck rejuvenation
Conditions
Interventions
Patient'
s neck was injected with cannula needle at this random side of the neck,Patient'
s neck was injected with sharp needle at this random side of the neck
Experimental Device,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. Age from 30-55 years, both male and female. 2. Participants with an early-stage sun-damaged skin in the neck area, as assessed by the following criteria (any one of the following): Uneven skin tone, Fine wrinkles, Dry skin, Skin laxity 3. Thai of Asian descent 4. Participants who consent to join the project voluntarily and agree to receive injections of polynucleotideswith the quantity and at the positions specified in the research protocol.
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 diseases. 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 with a diagnosed 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 affecting 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 |
|---|---|
| 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,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,Improvement Scale 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 Global Aesthetic Improvement Scale Assessment | — |
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 Quantificare,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,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,ITA 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 colorimeter,sebum 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 sebumeter,Hydration 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 corneometer,Physician assessment 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 Clinical photo,pain 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 visual analog scale,safety 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 adverse event | — |
Countries
Thailand
Contacts
Public ContactRungsima Wanitphakdeedecha
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed