Skin AgingNCT01490554
Autologous Fibroblast Grafts in Facial Skin Regeneration
A study testing autologous fibroblasts grafts in people with Skin Aging, run by Federal University of São Paulo.
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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- autologous fibroblasts grafts
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the detailed description
- Analytical prospective autocontrolled study
- Conditions
- Skin Aging
- Being tested
- autologous fibroblasts grafts
- Keywords
- Skin aging, fibroblasts, transplantation, autologous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous fibroblasts graftsProcedure or surgery
Autologous cultured fibroblasts will be grafted in facial skin
| Study group | Role | What they receive |
|---|---|---|
| autologous fibroblast grafts | Experimental | autologous fibroblast grafts Receives: Procedure: autologous fibroblasts grafts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year after the grafting of autologous fibroblasts.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startMar 2007
- Primary completionMar 2011
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LYDIA MASAKO FERREIRA, Federal University of São Paulo
- Investigators
- Lydia M Ferreira, MD, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490554
- Sponsor's protocol ID
- CEP UNIFESP-1787/07
- Status last verified
- Jul 2012
- First submitted
- 9 Dec 2011
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Autologous Fibroblast Grafts in the Regeneration of Facial Ectoderm
- ClinicalTrials.gov ID
- NCT01490554
- Acronym / sponsor ID
- CEP UNIFESP-1787/07
- Conditions
- Skin Aging
- Keywords
- Skin aging, fibroblasts, transplantation, autologous
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 13 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autologous fibroblast grafts | Experimental | Procedure: autologous fibroblasts graftsautologous fibroblast grafts |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous fibroblasts graftsAutologous cultured fibroblasts will be grafted in facial skin | Procedure or surgery | autologous fibroblast grafts |
Primary outcome
Regeneration of facial ectoderm
Time frame: one year after the grafting of autologous fibroblasts.
To evaluate the presence of skin changes after grafting of autologous fibroblasts by means of biophysical, histological, immunohistological, gene expression, glycosaminoglycan, and sensitivity analyses.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lydia M Ferreira, MD, PhD principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing autologous fibroblasts grafts in people with Skin Aging, run by Federal University of São Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regeneration of facial ectoderm (time frame: one year after the grafting of autologous fibroblasts.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2012.