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Autologous Fibroblast Grafts in Facial Skin Regeneration

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by LYDIA MASAKO FERREIRA, Federal University of São Paulo.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01490554
First Posted: December 13, 2011
Last Update Posted: July 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
LYDIA MASAKO FERREIRA, Federal University of São Paulo
  Purpose
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.

Condition Intervention
Skin Aging Procedure: autologous fibroblasts grafts

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Autologous Fibroblast Grafts in the Regeneration of Facial Ectoderm

Resource links provided by NLM:


Further study details as provided by LYDIA MASAKO FERREIRA, Federal University of São Paulo:

Primary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: March 2007
Estimated Study Completion Date: December 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: autologous fibroblast grafts
autologous fibroblast grafts
Procedure: autologous fibroblasts grafts
Autologous cultured fibroblasts will be grafted in facial skin

Detailed Description:
- Analytical prospective autocontrolled study
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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,
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01490554


Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Lydia M Ferreira, MD, PhD Federal University of Sao Paulo
  More Information

Responsible Party: 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
ClinicalTrials.gov Identifier: NCT01490554     History of Changes
Other Study ID Numbers: CEP UNIFESP-1787/07
First Submitted: December 9, 2011
First Posted: December 13, 2011
Last Update Posted: July 24, 2012
Last Verified: July 2012

Keywords provided by LYDIA MASAKO FERREIRA, Federal University of São Paulo:
Skin aging
fibroblasts
transplantation
autologous