Effects of cultured fibroblast on reducing nasolabial folds

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 60

Inclusion Criteria

Age between 30-60 years
Having nasolabial folds
Wrinkle Assessment Scale between 3 to 5
Nasolabial fold line length between 12-15 cm
Written consent to participate and willingness to attend in regular treatment / follow up visits

Exclusion Criteria

Having a known chronic disease
pregnancy or plan to be pregnant during the next 5 years
Lactation
history of cancer or chemotherapy
Having viral disease: HIV, HBV or HCV
History of cell therapy
History of lipotransfer at the nasolabial region
UV, laser or PRP interventions in the last 6 months
History of organ transplantation or blood transfusion
History of allergy to anesthetic drugs
History of using immunosuppresive or cytotoxic drugs in the last 6 months
History of Skin mass or benign skin diseases
History of anticoagulant use
Mesotherapy or skin surgery
Injection of permanent fillers
Injection of botulinum or fillers before the end of efficacy time
HSV history
Active infection at the injection site
Diabetes
Being under heavy diet for weigh loss or weight gain
Collagen of fibroblast producing diseases like marfan syndrome or epidermolysis bullosa
History of allergy to bovine products
History of allergy to streptomycin or penicillin
Using retinoid drugs during the last 6 months
Uncontrolled hypothyroidism or hyperthyroidism
History of severe mental problems like depression, anxiety disorders or bipolar disorders

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Remission rate. Timepoint: Before and nine months after injection. Method of measurement: Wrinkle assessment scale.

Secondary Outcome Measures

Name	Time	Method
Wrinkle Assessment Scale. Timepoint: Before and weeks 20, 32 and 44 after injection. Method of measurement: score 1 to 5 regarding image comparisons before and after injection.;Subject Self-assessment of wrinkle. Timepoint: Before and weeks 20, 32 and 44 after injection. Method of measurement: Subject Self-assessment Scale of wrinkle: scroe -2 to +2.;Length, depth and volume of wrinkle. Timepoint: Before and weeks 20, 32 and 44 after injection. Method of measurement: Two dimensional imaging by VisioFace.;Thickness of epiderm and derm and dermal density. Timepoint: Before and weeks 20, 32 and 44 after injection. Method of measurement: Ultrasonographic findings.;Adverse events. Timepoint: Every time happens. Method of measurement: From adverse events list.