Overview

This trial is active, not recruiting.

Condition skin aging
Treatment autologous fibroblasts grafts
Sponsor Federal University of São Paulo
Start date March 2007
End date March 2011
Trial size 20 participants
Trial identifier NCT01490554, CEP UNIFESP-1787/07

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
autologous fibroblast grafts
autologous fibroblasts grafts
Autologous cultured fibroblasts will be grafted in facial skin

Primary Outcomes

Measure
Regeneration of facial ectoderm
time frame: one year after the grafting of autologous fibroblasts.

Eligibility Criteria

Female participants from 50 years up to 70 years old.

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.

Additional Information

Official title Effectiveness of Autologous Fibroblast Grafts in the Regeneration of Facial Ectoderm
Principal investigator Lydia M Ferreira, MD, PhD
Description - Analytical prospective autocontrolled study
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by Federal University of São Paulo.