NCT00662961

Brief Summary

To compare periosteum versus bone fixation in forehead lift.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
Last Updated

April 21, 2008

Status Verified

April 1, 2008

Enrollment Period

6 months

First QC Date

April 15, 2008

Last Update Submit

April 17, 2008

Conditions

Forehead

Keywords

Plastic Surgery

Outcome Measures

Primary Outcomes (1)

  • Eye brow position

    6 months

Secondary Outcomes (2)

  • Patients' satisfaction

    6 months

  • Complications

    6 months

Study Arms (2)

1

EXPERIMENTAL

Periosteum

Procedure: Periosteum

2

EXPERIMENTAL

Bone

Procedure: Bone

Interventions

PeriosteumPROCEDURE

Periosteum fixation

1
BonePROCEDURE

Bone tunnel fixation

2

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eye brow malposition
  • Forehead wrinkles

You may not qualify if:

  • Previous surgery
  • Forehead trauma or scar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Uberlandia, Department of ENT/H&N

Uberlândia, Minas Gerais, 38400-368, Brazil

Location

Study Officials

  • Lucas G Patrocinio, MD

    Federal University of Uberlandia, Department of ENT/H&N

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 15, 2008

First Posted

April 21, 2008

Study Start

January 1, 2007

Primary Completion

July 1, 2007

Study Completion

August 1, 2007

Last Updated

April 21, 2008

Record last verified: 2008-04

Locations

BR(1)