Efficacy and safety of human dermal fibroblasts cultured in clinical-grade large scale cultured system compared to placebo in treatment of nasolabial folds : A randomized, placebo controlled phase 3, parallel, double blinded clinical trial

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

Target sample size: 60