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Clinical Trials/NCT01490554
NCT01490554
Unknown
Not Applicable

Effectiveness of Autologous Fibroblast Grafts in the Regeneration of Facial Ectoderm

Federal University of São Paulo0 sites20 target enrollmentMarch 2007
ConditionsSkin Aging

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Skin Aging
Sponsor
Federal University of São Paulo
Enrollment
20
Primary Endpoint
Regeneration of facial ectoderm
Last Updated
13 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 2007
End Date
December 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Federal University of São Paulo
Responsible Party
Principal Investigator
Principal Investigator

LYDIA MASAKO FERREIRA

Full Professor and Chairwoman and Head of the Division of Plastic Surgery and Department of Surgery, Federal University of Sao Paulo-UNIFESP, SP, Brazil

Federal University of São Paulo

Eligibility Criteria

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,
  • 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.

Outcomes

Primary Outcomes

Regeneration of facial ectoderm

Time Frame: 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.

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