Facial contour deformities
Phase 2
- Conditions
- Condition 1: Acne Scar. Condition 2: Wrinkle.Scar conditions and fibrosis of skinDisorder of skin and subcutaneous tissue, unspecified
- Registration Number
- IRCT201508201031N15
- Lead Sponsor
- Royan Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Inclusion Criteria: Age>18 years; facial wrinkle or acne scar of at-least 2 out 7; Ability to sign informed consent.
Exclusion Criteria
Known allergy or sensitivity to collagen fillers; history of soft tissue augmentation to the area during last 6 months; autologous fat transfer in the last 6 months; facial Kaposi sarcoma; active skin diseases or inflammation of the treatment area; Silicon injection in treatment site; pregnancy or lactating; systemic immunosuppressive or steroid drugs during past 6 months; current anticoagulant therapy; disease of connective tissue; malignant disease; Positive HIV, HBV, HCV
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decrease in scar and wrinkle score. Timepoint: 2, 6 and 12 months after cell injection. Method of measurement: Based on evaluator assessment score according to standardized 7-point grading.
- Secondary Outcome Measures
Name Time Method Safety. Timepoint: 2, 6 and 12 months after cell injection. Method of measurement: Assessments based on evaluator and subject.