- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00662961
Forehead Lift Fixation (Forehead)
April 17, 2008 updated by: Federal University of Uberlandia
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
MG
-
Uberlandia, MG, Brazil, 38400-368
- Federal University of Uberlandia, Department of ENT/H&N
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Eye brow malposition
- Forehead wrinkles
Exclusion Criteria:
- Previous surgery
- Forehead trauma or scar
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Periosteum
|
Periosteum fixation
|
|
Experimental: 2
Bone
|
Bone tunnel fixation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Eye brow position
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Complications
Time Frame: 6 months
|
6 months
|
|
Patients' satisfaction
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lucas G Patrocinio, MD, Federal University of Uberlandia, Department of ENT/H&N
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
July 1, 2007
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
April 15, 2008
First Submitted That Met QC Criteria
April 17, 2008
First Posted (Estimate)
April 21, 2008
Study Record Updates
Last Update Posted (Estimate)
April 21, 2008
Last Update Submitted That Met QC Criteria
April 17, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2-Patrocinio
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.