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IRCT20100127003200N5 IRCT 2018-06-10 Barkat pharmaceutical group Effects of cultured fibroblast on reducing nasolabial folds 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 2019-02-04 anticipated 60 Complete https://irct.ir/trial/3242 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization list will be generated using online source: https://www.sealedenvelope.com. Block randomization with block size 4 results in generation of 15 blocks. After the randomization list generation, every patient will be assigned a unique identification code. All the staff conducting the study will be blinded to randomization list. Opaque sealed consecutively numbered envelopes will be used for the allocation concealment process.Each envelope will be opened after assuring eligibility of the participant and giving written signed consent form, Blinding description: patients will receive similar 100 units, gauge 30 syringes in both groups. Those who conduct the injections are different form those who conduct the examinations and patients' assessments. The packages of investigational products will be labelled by unique codes. 3 Nasolabial folds. Intervention 1: Control group: Placebo injection 0.1 ml/cm in each injection: three injections in 4 consecutive weeks. Intervention 2: Intervention group: Fibroblast injection 20 millions of cells in 0.1 ml/cm in each injection: three injections in 4 consecutive weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Individual data will be provided only for regulatory organization and IRB
public Saeid Shafieian
Royan Ave.,East Hafez St., Banihashem St.
Tehran Iran (Islamic Republic of) 1665664511 +98 21 2356 2171 sshafiiyan@yahoo.com Royan Institute for Stem Cell Biology and Technology scientific Saeid Shafieian
Royan Ave.,East Hafez St., Banihashem St.
Tehran Iran (Islamic Republic of) 1665664511 +98 21 2356 2171 sshafiiyan@yahoo.com Royan Institute for Stem Cell Biology and Technology Iran (Islamic Republic of) 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 30 years 60 years Both 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 L98.8 Other specified disorders of the skin and subcutaneous tissue Placebo Treatment - Drugs Control group: Placebo injection 0.1 ml/cm in each injection: three injections in 4 consecutive weeks Intervention group: Fibroblast injection 20 millions of cells in 0.1 ml/cm in each injection: three injections in 4 consecutive weeks Remission rate. Timepoint: Before and nine months after injection. Method of measurement: Wrinkle assessment scale. 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. Barkat pharmaceutical group Approved 2018-04-18 Ethics committee of Vice chancellor for research, Tehran University of Medical Sciences Qods street Tehran Tehran Iran (Islamic Republic of)