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Efficacy assessment of cell therapy in skin aging

Phase 2
Recruiting
Conditions
Atrophic disorders of skin (aging).
Atrophic disorder of skin
Z68.53
Registration Number
IRCT20141007019432N3
Lead Sponsor
Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
46
Inclusion Criteria

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
Negative pregnancy test (Females)

Exclusion Criteria

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 filler'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
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
NameTimeMethod
Quantity of facial wrinkle - Extension. Timepoint: Months: 1, 3 and 6 after cell therapy. Method of measurement: Biometry with visioface & skin sonography.;Quality of facial wrinkle - deep. Timepoint: Months: 1, 3 and 6 after cell therapy. Method of measurement: Biometry with visioface & skin sonography.
Secondary Outcome Measures
NameTimeMethod
Color. Timepoint: Months: 1, 3 and 6 after cell therapy. Method of measurement: Biometry with colorimeter.;Elastisity. Timepoint: Months: 1, 3 and 6 after cell therapy. Method of measurement: MPA 9.
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