patient with sign of aging at facial, neck and nasolabial fold area facial rejuvenate, neck rejuvenate, PDLLA, hyaluronic acid
Conditions
Interventions
Patients receive 3 treatment sessions of PDLLA combined with HA injection at face, neck and nasolabial fold each session spaced 1 month apart. Patient are follow up at 2 weeks after 1st treatment, 1-,
Experimental Device
PDLLA combined with hyaluronic acid injection
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
No Study Secondary Sponsor
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. age 30 or above both gender 2. agree to receive treatment and follow up as protocol 3 was diagnosed with moderate degree of photo aging by dermatologist 4 was diagnosed with moderate degree of wrinkle severity rating scale at nasolabial fold area
Exclusion criteria
Exclusion criteria: 1. Patients who are pregnant, lactating, and postpartum within 1 year 2. Patients who taking oral contraceptive pill, contraceptive injection 3. Patients with other skin diseases, or having infection at the area of face and neck 4. Immunocompromised patients 5. Patients with hypertrophic scar or keloid 6. Patients with history of Cushing syndrome or Ehlers-Danlos syndrome 7. Patients with cancers or skin cancers 8. Patient with hypersensitivity to local anesthesia 9. Patient who have underwent botox with in 6 months prior to study 10. Patient who have underwent filler injection with in 24 months prior to study 11. Patient who have underwent facial rejuvenation, thread lifting and laser for facial rejuvenate with in 6 months prior to study 12 Patient with coagulation disorder or currently taking anti coagulation medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| wrinkle by Antera baseline, 2 wk after 1st treatment, 2nd treatment, 3rd treatment, 1 month, 3 months, 6 months, 9 months and 12 months after complete treatment Antera,texture baseline, 2 wk after 1st treatment, 2nd treatment, 3rd treatment, 1 month, 3 months, 6 months, 9 months and 12 months after complete treatment Antera | — |
Secondary
| Measure | Time frame |
|---|---|
| Volume change baseline, 2 wk after 1st treatment, 2nd treatment, 3rd treatment, 1 month, 3 months, 6 months, 9 months and 12 months after complete treatment Vectra,skin elasticity and firmness baseline, 2 wk after 1st treatment, 2nd treatment, 3rd treatment, 1 month, 3 months, 6 months, 9 months and 12 months after complete treatment Cutometer,melanin baseline, 2 wk after 1st treatment, 2nd treatment, 3rd treatment, 1 month, 3 months, 6 months, 9 months and 12 months after complete treatment Mexameter,erythema baseline, 2 wk after 1st treatment, 2nd treatment, 3rd treatment, 1 month, 3 months, 6 months, 9 months and 12 months after complete treatment mexameter,hydration baseline, 2 wk after 1st treatment, 2nd treatment, 3rd treatment, 1 month, 3 months, 6 months, 9 months and 12 months after complete treatment corneometer,sebum baseline, 2 wk after 1st treatment, 2nd treatment, 3rd treatment, 1 month, 3 months, 6 months, 9 months and 12 months after complete treatment sebumeter,Patient assessment baseline, 2 wk after 1st treatment, 2nd treatment, 3rd treatment, 1 month, 3 months, 6 months, 9 months and 12 months after complete treatment GAIS,Adverse event baseline, 2 wk after 1st treatment, 2nd treatment, 3rd treatment, 1 month, 3 months, 6 months, 9 months and 12 months after complete treatment note,Pain score baseline, 2nd treatment, 3rd treatment visual analog scale | — |
Countries
Thailand
Contacts
Public ContactThanya Techapichetvanich
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed