Nasolabial folds. Other specified disorders of the skin and subcutaneous tissue
Conditions
Interventions
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
Sponsors
Barkat pharmaceutical group
Eligibility
Sex/Gender
All
Age
30 Years to 60 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate. Timepoint: Before and nine months after injection. Method of measurement: Wrinkle assessment scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSaeid Shafieian
Royan Institute for Stem Cell Biology and Technology
Outcome results
None listed