photodamaged skin, photoaging photodamaged skin, photoaging
Conditions
Interventions
polynucleotide 10 mg/mL, hyaluronic acid 20 mg/mL, and lidocaine 2.8 mg/mL
Experimental Device
Polynucleotide + HA
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. Participants seeking improvement of neck skin concerns, specifically hyperpigmentation and fine wrinkles. 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 dermatitis, wounds, or active skin infection on the face or neck. 3. History of facial and/or neck tightening procedures within the past 6 months. 4. Presence of severe underlying medical conditions. 5. History of filler injections, thread lifting, or polynucleotide injections within the past 12 months. 6. History of botulinum toxin injection within the past 6 months. 7. History of keloids or hypertrophic scarring. 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 blood coagulation such as aspirin. 11. Participants with a history of allergy to local anesthetics or polynucleotides.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| wrinkles baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1, 3, 6, 9 and 12 months after treatment Antera,Texture baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1, 3, 6, 9 and 12 months after treatment Antera,Global Aesthetic Improvement Scale Assessment (GAIS) 1 month after 1st treatment, 1 month after 2nd treatment, 1, 3, 6, 9 and 12 months after treatment Physician assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| Participants improvement scale 1 month after 1st treatment, 1 month after 2nd treatment, 1, 3, 6, 9 and 12 months after treatment Quartile scale,Safety 1 month after 1st treatment, 1 month after 2nd treatment, 1, 3, 6, 9 and 12 months after treatment Adverse event | — |
Countries
Thailand
Contacts
Public ContactThanya Techapichetvanich
Department of Dermatology, Faculty of medicine Siriraj hospital, Mahidol university
Outcome results
None listed