NCT01490554

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2011

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 24, 2012

Status Verified

July 1, 2012

Enrollment Period

4 years

First QC Date

December 9, 2011

Last Update Submit

July 23, 2012

Conditions

Skin Aging

Keywords

Skin agingfibroblaststransplantationautologous

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

autologous fibroblast grafts

EXPERIMENTAL

autologous fibroblast grafts

Procedure: autologous fibroblasts grafts

Interventions

autologous fibroblasts graftsPROCEDURE

Autologous cultured fibroblasts will be grafted in facial skin

autologous fibroblast grafts

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Lydia M Ferreira, MD, PhD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor and Chairwoman and Head of the Division of Plastic Surgery and Department of Surgery, Federal University of Sao Paulo-UNIFESP, SP, Brazil

Study Record Dates

First Submitted

December 9, 2011

First Posted

December 13, 2011

Study Start

March 1, 2007

Primary Completion

March 1, 2011

Study Completion

December 1, 2012

Last Updated

July 24, 2012

Record last verified: 2012-07