Biostimulators, Fibroblasts Biostimulators, Fibroblasts
Conditions
Interventions
Hyaluronic acid 12 mg/ml + Lidocaine 3 g + Phosphate buffer (no dilution) 0.04 ml,Hyaluronic acid 20 mg/ml + Glycerol 17.5 mg/ml (no dilution) 0.04 ml,Sodium polynucleotide 20 mg/ml (no dilution) 0.0
Experimental Device,Experimental Device,Experimental Device,Experimental Device,Experimental Device,Experimental Device,Experimental Device,Experimental Device,Experimental Device,Experimental Device,
Low molecular weight Hyaluronic acid,Hyaluronic acid + Glycerol,Sodium polynucleotide,Liquidified Polycaprolactone,Polydioxanone, Poly-L-Lactic Acid , Poly-D-L-Lactic Acid , Poly-D-L-Lactic Acid + HA
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Male or female participants. Age at least 18 years old. 2. Patients with a medical indication for surgical excision involving removal of skin and subcutaneous fat (e.g., mastectomy, abdominoplasty). 3. Ability to provide informed consent and independently decide on study participation. 4. Willingness to provide written informed consent prior to any study-related procedures or data collection. 5. Able to communicate with the research team, understand instructions, and comply with study requirements. 6. No active dermatitis or skin inflammation at the time of skin or blood sample collection; if previously present, symptoms must have resolved for at least 1 month.
Exclusion criteria
Exclusion criteria: 1. History of connective tissue disorders or skin cancer. 2. Underlying medical conditions such as diabetes, hypertension, or hyperlipidemia that are poorly controlled (HbA1c > 9%, blood pressure > 180/100 mmHg, or total cholesterol > 300 mg/dL). 3. Pregnant or breastfeeding women, or those with a positive pregnancy test. 4. History of radiation therapy to the area planned for skin excision. 5. Prior treatment with skin-tightening devices in the area to be excised. 6. Prior collagen-stimulating laser treatments in the area to be excised (e.g., picosecond laser, Er:YAG laser, Fractora, E-matrix). 7. Prior collagen-stimulating injections, dermal fillers, platelet-rich plasma (PRP), or botulinum toxin in the area to be excised. 8. History of keloids or hypertrophic scarring. 9. Presence of dermatitis or skin infection at the planned biopsy site. 10. History of platelet disorders, coagulation abnormalities, anemia, liver disease, or immunodeficiency. 11. Active smokers or individuals with a history of heavy alcohol consumption. 12. Regular use of hormonal therapy or contraceptives (oral or injectable), or chronic use of non-steroidal anti-inflammatory drugs (NSAIDs). 13. Use of medications affecting blood coagulation (e.g., aspirin, anticoagulants). 14. Use of immunosuppressive medications. 15. Diagnosed psychiatric disorders by a psychiatrist. 16. Participants who do not permit photography for treatment evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PDGF-AA (two A subunits Platelet-derived growth factor) at the end of study Luminex cytokines/chemokines/growth factors detection kit ,PDGF-BB (two B subunits Platelet-derived growth factor) at the end of study Luminex cytokines/chemokines/growth factors detection kit ,Th1/Th2 Cytokines (IFN-gamma, IL-2, IL-4, IL-5, IL-10, IL-12 (p70), IL-13, TNF- alpha, TGF-beta1, IL-1alpha, and IL-1beta) at the end of study Luminex cytokines/chemokines/growth factors detection kit | — |
Secondary
| Measure | Time frame |
|---|---|
| collagen type III at the end of study ELISA kit ,collagen type I at the end of study ELISA kit | — |
Countries
Thailand
Contacts
Public ContactSarawalai Rakchart
Faculty of medicine Siriraj hospital, Mahidol university
Outcome results
None listed