Autologous Fibroblast Grafts in Facial Skin Regeneration

Not Applicable

• Conditions: Skin Aging

• Registration Number: NCT01490554
• Lead Sponsor: Federal University of São Paulo

Brief Summary

The purpose of this study is to evaluate the presence of skin changes after grafting of autologous fibroblasts by means of biophysical, histological, immunohistological, gene expression, glycosaminoglycan, and sensitivity analyses.

Detailed Description

- Analytical prospective autocontrolled study

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2011-03
• Study First Submitted: 2011-12-09
• Study First Submitted QC: 2011-12-12
• Study First Posted: 2011-12-13
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-23
• Last Update Posted: 2012-07-24
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Women, aged between 50 to 70 years with facial wrinkles (rhytides),
• Fitzpatrick III skin type, and
• Who had reached menopause at least 3 years before entering the study were eligible for participation.

Exclusion Criteria

• Women with uncontrolled comorbid conditions,
• Smokers,
• Alcohol and corticosteroid users,
• Who had undergone chemical peeling or skin filling in the face or neck at least 12 months prior to the study,
• Who had a keloid scar,
• Who scored below 18 on the Mini-Mental State Examination,
• Who had any psychiatric disorder or those undergoing orthodontic treatment were excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Regeneration of facial ectoderm	one year after the grafting of autologous fibroblasts.	To evaluate the presence of skin changes after grafting of autologous fibroblasts by means of biophysical, histological, immunohistological, gene expression, glycosaminoglycan, and sensitivity analyses.