IRCT20100127003200N5
Not yet recruiting
Phase 3
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 sites60 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Barkat pharmaceutical group
- Enrollment
- 60
- Status
- Not yet recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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