Forehead Lift Fixation | NCT00662961

Studies
Forehead Lift Fixation

NCT00662961

Sponsor

Federal University of Uberlandia

Status

Completed

Last Update Posted

Apr 21, 2008Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Forehead

Interventions

Periosteum
Bone

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Jul 2007Actual

Completion Date

Aug 2007Actual

First Submitted Date

Apr 15, 2008

First Submission Date that Met QC Criteria

Apr 17, 2008

First Posted Date

Apr 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2008

Last Update Posted Date

Apr 21, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Periosteum	Procedure: Periosteum
2	Experimental	Bone	Procedure: Bone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Periosteum	Procedure	Periosteum fixation	1
Bone

Measure	Description	Time Frame
Eye brow position		6 months

Measure	Description	Time Frame
Patients' satisfaction		6 months
Complications		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eye brow malposition
Forehead wrinkles

Exclusion Criteria:

Previous surgery
Forehead trauma or scar

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lucas G Patrocinio, MD	Federal University of Uberlandia, Department of ENT/H&N	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Federal University of Uberlandia, Department of ENT/H&N		Uberlândia	Minas Gerais	38400-368	Brazil