Efficacy of Autologous Fibroblasts on Facial Rejuvenation: A Pilot Study

Phase 4

Recruiting

• 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

• Registration Number: TCTR20220731001
• Lead Sponsor: Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-31
• Study Completion: 2024-06-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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

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 .

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Skin Wrinkle Baseline,1,3,6,12 months Antera,Skin Volume Baseline,1,3,6,12 months Vectra

Secondary Outcome Measures

Name	Time	Method
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