Efficacy assessment of cell therapy in skin aging
- Conditions
- Atrophic disorders of skin (aging).Atrophic disorder of skinZ68.53
- Registration Number
- IRCT20141007019432N2
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 46
age about 35 to 65 years old
Having no anatomic disorder in face
Wrinkle type between grade 2 to 4
Normal mental health
Ability to comply with the study requirements
Provide written informed consent and comply with the study requirements
Negative pregnancy test (Females)
being smokers or drinkers
any past skin intervention in face
Having many wrinkles on the face
type of 1 or 5 of wrinkle scoring
having a mental disorder
Previous treatment with the sponsor's product
History of active autoimmune disease or organ transplantation
Diagnosis of cancer, unless successfully treated or in remission (basal cell carcinoma is excluded)
Active or chronic skin disease
Known genetic disorders affecting fibroblasts or collagen
Active systemic infection
Requires chronic antibiotic or steroidal therapy
Use of certain commercial products/procedures to the treatment area prior to study enrollment or plans for use during the study
Known allergic reactions to agents used in preparation of treatment
Excessive exposure to sun without adequate sun protection
Use of systemic agents that increase bleeding or clotting, or disorders equated with these effects
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quantity of facial wrinkle - Extension. Timepoint: 1- 3 - 6 Month after cell therapy. Method of measurement: Biometry with visioface & skin sonography.;Quality of facial wrinkle - deep. Timepoint: 1 - 3 - 6 Month after intervention. Method of measurement: Biometry with visioface & skin sonography.
- Secondary Outcome Measures
Name Time Method Color. Timepoint: 1 - 3 - 6 Month after cell therapy. Method of measurement: Biometry with colorimeter.;Elastisity. Timepoint: 1 - 3 - 6 Month after cell therapy. Method of measurement: MPA 9.