Autologous Fibroblast Grafts in Facial Skin Regeneration

Skin Aging Clinical Trial

Official title:

Effectiveness of Autologous Fibroblast Grafts in the Regeneration of Facial Ectoderm

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01490554
• Other study ID #: CEP UNIFESP-1787/07
• Status: Active, not recruiting
• Phase: N/A
• First received: December 9, 2011
• Last updated: July 23, 2012
• Start date: March 2007
• Est. completion date: December 2012

Study information

• Verified date: July 2012
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil : Research Ethics CommitteeBrazil : ANVISA
• Study type: Interventional

Clinical Trial 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.

Description:

- Analytical prospective autocontrolled study

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Skin Aging

Intervention

Procedure:
• autologous fibroblasts grafts
Autologous cultured fibroblasts will be grafted in facial skin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes