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

Barkat pharmaceutical group0 个研究点目标入组 60 人开始时间: 待定最近更新: 2019年1月14日

试验速览

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•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

•Having a known chronic disease
•pregnancy or plan to be pregnant during the next 5 years
•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
•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

发起方

Barkat pharmaceutical group