laxity, wrinkle laxity, wrinkle
Conditions
Interventions
Each participant will be randomly assigned to receive treatment using the Bio Asian Aesthetic Technique with sharp needle injection for two sessions spaced one month apart.,On the contralateral side o
Experimental Device,Active Comparator Device
bio-asian aesthetic technique,bio aesthetic technique
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Eligibility
Sex/Gender
All
Age
30 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Male and female participants aged 30 to 60 years 2. Participants who voluntarily agree to participate in the study 3. Participants seeking treatment for facial and neck skin concerns including hyperpigmentation and wrinkles 4. Participants with facial and neck skin evaluated by a board certified dermatologist using the Glogau Classification of Photoaging with a grade of moderate or higher
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding participants 2. Participants with a history of platelet disorders bleeding or coagulation disorders anemia liver disease cancer or autoimmune diseases 3. Participants who smoke or have a history of heavy alcohol consumption 4. Participants with active dermatitis wounds or skin infection on the face 5. Participants with a history of allergy to local anesthetics 6. Participants with a history of hormone therapy use including injectable or oral contraceptives or regular use of NSAIDs 7. Participants taking medications affecting blood coagulation such as aspirin or anticoagulants 8. Participants who underwent facial lifting procedures including energy based devices or thread lifting within 12 months prior to study enrollment 9. Participants who received facial dermal filler injections within 24 months prior to study enrollment 10. Participants who received platelet rich plasma injections to the face within 12 months prior to study enrollment 11. Participants who received botulinum toxin injections to the face within 6 months prior to study enrollment 12. Participants who underwent collagen stimulating laser treatments to the face such as picosecond laser Erbium YAG laser Fractora or Laser E matrix within 12 months prior to study enrollment 13. Participants with a history of hypertrophic scar or keloid formation 14. Participants with diagnosed psychiatric disorders 15. Participants who do not consent to clinical photography for treatment evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| wrinkle Baseline, 1 month after first treatment, 1 month after second treatment, and 3, 6, 9, and 12 months after second treatment Antera3D,skin texture Baseline, 1 month after first treatment, 1 month after second treatment, and 3, 6, 9, and 12 months after second treatment Antera3D | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in facial volume Baseline, 1 month after first treatment, 1 month after second treatment, and 3, 6, 9, and 12 months after second treatment Quantificare,skin elasticity Baseline, 1 month after first treatment, 1 month after second treatment, and 3, 6, 9, and 12 months after second treatment Cutometer,melanin index and erythema index Baseline, 1 month after first treatment, 1 month after second treatment, and 3, 6, 9, and 12 months after second treatment Mexameter,skin hydration Baseline, 1 month after first treatment, 1 month after second treatment, and 3, 6, 9, and 12 months after second treatment Corneometer,Individual Typology Angle, ITA Baseline, 1 month after first treatment, 1 month after second treatment, and 3, 6, 9, and 12 months after second treatment Colorimeter,sebum level Baseline, 1 month after first treatment, 1 month after second treatment, and 3, 6, 9, and 12 months after second treatment Sebumeter,Investigator assessment of clinical improvement 1 month after first treatment, 1 month after second treatment, and 3, 6, 9, and 12 months after second treatment Quartile scale,Participant self assessment of treatment improvement 1 month after first treatment, 1 month after second treatment, and 3, 6, 9, and 12 months after second treatment Quartile scale,Pain Baseline, 1 month after first treatment, 1 month after second treatment, and 3, 6, 9, and 12 months after second treatment Visual Analog Scale (VAS),Safety Baseline, 1 month after first treatment, 1 month after second treatment, and 3, 6, 9, and 12 months after second treatment Adverse events | — |
Countries
Thailand
Contacts
Public ContactRungsima Wanitphakdeedecha
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed