ForeheadForeheadNCT00662961
Forehead Lift Fixation
A study testing Periosteum and Bone in people with Forehead, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
To compare periosteum versus bone fixation in forehead lift. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Forehead
- What is being tested?
- Periosteum and Bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2007to Aug 2007
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eye brow malposition
- Forehead wrinkles
Who cannot join
- Previous surgery
- Forehead trauma or scar
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Uberlandia, Department of ENT/H&N
Uberlândia, Minas Gerais, 38400-368
About this study
Official title: Periosteum Versus Bone for the Fixation of Forehead Lift: A Prospective, Randomized, Controlled, Split-Face Trial.
To compare periosteum versus bone fixation in forehead lift.
Read the detailed description
Forehead lift method of fixation is variable and lots of different methods have been described with different rates of success.
The comparison of to different techniques in a RCT has not been reported before.
The objective is to compare periosteum versus bone fixation in forehead lift, in a randomized, blinded, controlled, split-face trial.
- Conditions
- Forehead
- Being tested
- Periosteum, Bone
- Keywords
- Plastic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeriosteumProcedure or surgery
Periosteum fixation
BoneProcedure or surgery
Bone tunnel fixation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Periosteum Receives: Procedure: Periosteum |
| 2 | Experimental | Bone Receives: Procedure: Bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye brow position
Measured: 6 months
Secondary outcomes (2)
Patients' satisfaction
Measured: 6 months
Complications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startJan 2007
- Primary completionJul 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ForeheadStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Investigators
- Lucas G Patrocinio, MD, Principal investigator, Federal University of Uberlandia, Department of ENT/H&N
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662961
- Sponsor's protocol ID
- 2-Patrocinio
- Acronym
- Forehead
- Status last verified
- Apr 2008
- First submitted
- 15 Apr 2008
- Last updated
- 21 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periosteum Versus Bone for the Fixation of Forehead Lift: A Prospective, Randomized, Controlled, Split-Face Trial.
- ClinicalTrials.gov ID
- NCT00662961
- Acronym / sponsor ID
- Forehead / 2-Patrocinio
- Conditions
- Forehead
- Keywords
- Plastic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jul 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 21 Apr 2008 (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.
To compare periosteum versus bone fixation in forehead lift.
Detailed description
Forehead lift method of fixation is variable and lots of different methods have been described with different rates of success.
The comparison of to different techniques in a RCT has not been reported before.
The objective is to compare periosteum versus bone fixation in forehead lift, in a randomized, blinded, controlled, split-face trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: PeriosteumPeriosteum |
| 2 | Experimental | Procedure: BoneBone |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eye brow malposition
- Forehead wrinkles
Key exclusion criteria (2 listed)
- Previous surgery
- Forehead trauma or 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 |
|---|---|---|
| PeriosteumPeriosteum fixation | Procedure or surgery | 1 |
| BoneBone tunnel fixation | Procedure or surgery | 2 |
Primary outcome
Eye brow position
Time frame: 6 months
2 secondary outcomes
Patients' satisfaction
Time frame: 6 months
Complications
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2008.
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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.
Lucas G Patrocinio, MD principal investigator
Federal University of Uberlandia, Department of ENT/H&N
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periosteum and Bone in people with Forehead, run by Federal University of Uberlandia at 1 site in Brazil.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 21 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Eye brow position (time frame: 6 months). 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 21 Apr 2008.