Autologous Fibroblast Grafts in Facial Skin Regeneration

July 23, 2012 updated by: LYDIA MASAKO FERREIRA, Federal University of São Paulo

Effectiveness of Autologous Fibroblast Grafts in the Regeneration of Facial Ectoderm

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

- Analytical prospective autocontrolled study

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: autologous fibroblast grafts
Procedure: autologous fibroblasts grafts
Autologous cultured fibroblasts will be grafted in facial skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year after the grafting of autologous fibroblasts.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Lydia M Ferreira, MD, PhD, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

March 1, 2011

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

December 9, 2011

First Submitted That Met QC Criteria

December 12, 2011

First Posted (Estimate)

December 13, 2011

Study Record Updates

Last Update Posted (Estimate)

July 24, 2012

Last Update Submitted That Met QC Criteria

July 23, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CEP UNIFESP-1787/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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