Autologous Fibroblast Grafts in Facial Skin Regeneration

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Federal University of São Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
LYDIA MASAKO FERREIRA, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01490554
First received: December 9, 2011
Last updated: July 23, 2012
Last verified: July 2012

December 9, 2011
July 23, 2012
March 2007
March 2011   (final data collection date for primary outcome measure)
Regeneration of facial ectoderm [ Time Frame: one year after the grafting of autologous fibroblasts. ] [ Designated as safety issue: Yes ]
To evaluate the presence of skin changes after grafting of autologous fibroblasts by means of biophysical, histological, immunohistological, gene expression, glycosaminoglycan, and sensitivity analyses.
Same as current
Complete list of historical versions of study NCT01490554 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Autologous Fibroblast Grafts in Facial Skin Regeneration
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.

- Analytical prospective autocontrolled study

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Skin Aging
Procedure: autologous fibroblasts grafts
Autologous cultured fibroblasts will be grafted in facial skin
Experimental: autologous fibroblast grafts
autologous fibroblast grafts
Intervention: Procedure: autologous fibroblasts grafts
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
December 2012
March 2011   (final data collection date for primary outcome measure)

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.
Female
50 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01490554
CEP UNIFESP-1787/07
Yes
LYDIA MASAKO FERREIRA, Federal University of São Paulo
Federal University of São Paulo
Not Provided
Principal Investigator: Lydia M Ferreira, MD, PhD Federal University of Sao Paulo
Federal University of São Paulo
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP