Autologous Fibroblast Grafts in Facial Skin Regeneration

NCT ID: NCT01490554

Last Updated: 2012-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2012-12-31

Brief Summary

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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

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\- Analytical prospective autocontrolled study

Conditions

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Skin Aging

Keywords

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Skin aging fibroblasts transplantation autologous

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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autologous fibroblast grafts

autologous fibroblast grafts

Group Type EXPERIMENTAL

autologous fibroblasts grafts

Intervention Type PROCEDURE

Autologous cultured fibroblasts will be grafted in facial skin

Interventions

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autologous fibroblasts grafts

Autologous cultured fibroblasts will be grafted in facial skin

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lydia M Ferreira, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Other Identifiers

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CEP UNIFESP-1787/07

Identifier Type: -

Identifier Source: org_study_id