Autologous Fibroblast Grafts in Facial Skin Regeneration | NCT01490554

Studies
Autologous Fibroblast Grafts in Facial Skin Regeneration

NCT01490554

Sponsor

Federal University of São Paulo

Status

Unknown status

Last Update Posted

Jul 24, 2012Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Skin Aging

Interventions

autologous fibroblasts grafts

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Mar 2011Actual

Completion Date

Dec 2012Estimated

First Submitted Date

Dec 9, 2011

First Submission Date that Met QC Criteria

Dec 12, 2011

First Posted Date

Dec 13, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2012

Last Update Posted Date

Jul 24, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

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 PauloPrincipal Investigator

Lead Sponsor

Federal University of São PauloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
autologous fibroblast grafts	Experimental	autologous fibroblast grafts	Procedure: autologous fibroblasts grafts

Interventions

Name	Type	Description	Arm Group Labels	Other Names
autologous fibroblasts grafts	Procedure	Autologous cultured fibroblasts will be grafted in facial skin	autologous fibroblast grafts

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Regeneration of facial ectoderm	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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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,
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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lydia M Ferreira, MD, PhD	Federal University of São Paulo	Principal Investigator

Locations

Not provided