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Efficacy of Autologous Fibroblasts on Facial Rejuvenation: A Pilot Study

Efficacy of Autologous Fibroblasts on Facial Rejuvenation: A Pilot Study

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220731001
Enrollment
30
Registered
2022-07-31
Start date
2022-07-26
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient with wrinkle at cheek and periorbital with score of -2 to -1 by wrinkle patient assessment score Facial Rejuvenation, Autologous Fibroblasts, wrinkle at cheek and periorbital

Interventions

Patients were treated by first punch biopsy at back of the ear which inject adrenaline before biopsy. Second the biopsy will be cultured at sterile standard room. Then the patient will be injected by
Experimental Device

Sponsors

Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 older 2. Patient with wrinkle at cheek and periorbital with score of -2 to -1 by wrinkle patient assessment score which have 5 score : Very satisfied(+2), Satisfied(+1), Mild satisfied(0), not satisfied(-1), very not satified(-2)

Exclusion criteria

Exclusion criteria: 1. Patients who are pregnant, lactating, and postpartum. 2.Patient with autoimmune disease, transplantation, cancer, fibroblast or collagen genetic disorder for example Epidermolysis bullosa, Ataxia telangiectasis, skin cancer or others disease that affect the research. 3.Patient with history of treatment by autologous fibroblast . 4.Patient with history of treatment by inject any substances at cheek or lower face in 12 months before the research. 5.Patient with history of treatment by focus ultrasound or ablative laser or others that affect the cheek or lower face in 12 months before the research. 6.Patient with history of treatment by ultra phono, chemical peeling and cream or drug for treat wrinkle like tretinoin at cheek or lower face within 1 month. 7.Allergy to collagen , diary products, Gentamicin A, Amphotericin B and local anesthesia. 8.Patient with bleeding precaution, thrombocytopenia, take an anti-platelet drug that cannot stop and taking steroid drug or immunosuppressive drug. 9.Patient with history of hypertrophic scar or Keloid .

Design outcomes

Primary

MeasureTime frame
Skin Wrinkle Baseline,1,3,6,12 months Antera,Skin Volume Baseline,1,3,6,12 months Vectra

Secondary

MeasureTime frame
Percent improvement Baseline,1,3,6,12 months Dermatologist improvement scale,Percent improvement Baseline,1,3,6,12 months Patient improvement scale,Safety Baseline, After treatment, 1,3,6,12 months Adverse effect

Countries

Thailand

Contacts

Public ContactRungsima Wanitphakdeedecha

Faculty of Medicine Siriraj Hospital, Mahidol University

rungsima.wan@mahidol.ac.th66816406300

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026