NCT00347308

Brief Summary

Forehead and eyebrow surgery is a frequently performed cosmetic surgical procedure in which the eyebrows are raised to a more aesthetically pleasing position. Typically, this position is judged by the surgeon pre-operatively based on traditional aesthetic concepts, some of which date to the Classical era. This study is designed to assess the variance of the eyebrow from the desired aesthetic position (as determined by the subject), as wel as to assess the distance of normal excursion of the brow from maximum voluntary depression to maximum voluntary elevation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2007

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

First Submitted

Initial submission to the registry

June 29, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
12 months until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
9 months until next milestone

Results Posted

Study results publicly available

September 16, 2009

Completed
Last Updated

May 3, 2012

Status Verified

April 1, 2012

Enrollment Period

1.4 years

First QC Date

June 29, 2006

Results QC Date

August 10, 2009

Last Update Submit

April 29, 2012

Conditions

Brow Ptosis

Keywords

brow ptosis, facial aesthetics, browlift, facelift

Outcome Measures

Primary Outcomes (1)

  • Eyebrow Position

    Position of eyebrow at the medial canthus relative to orbital rim

    At time of evaluation

Interventions

Eyebrow PositionBEHAVIORAL

Photography of brow positions

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults, between the ages of 18- 85

You may qualify if:

  • adults,
  • aged 18-85 years

You may not qualify if:

  • prior forehead, eyebrow or eyelid surgery,
  • neurotoxin treatment to the forehead or eyes within the past 6 months,
  • injectable soft tissue filler used within the last 12 months,
  • photosensitivity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Facial Plastic Surgery

Chappaqua, New York, 10514, United States

Location

Related Publications (1)

  • Sclafani AP, Jung M. Desired position, shape, and dynamic range of the normal adult eyebrow. Arch Facial Plast Surg. 2010 Mar-Apr;12(2):123-7. doi: 10.1001/archfacial.2010.17.

    PMID: 20231595DERIVED

Results Point of Contact

Title
Anthony P. Sclafani, MD
Organization
The New York Eye & Ear Infirmary
asclafani@nyee.edu
212-979-4200

Study Officials

  • Anthony P Sclafani, MD

    The New York Eye & Ear Infirmary

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Facial Plastic Surgery

Study Record Dates

First Submitted

June 29, 2006

First Posted

July 4, 2006

Study Start

July 1, 2007

Primary Completion

December 1, 2008

Study Completion

January 1, 2009

Last Updated

May 3, 2012

Results First Posted

September 16, 2009

Record last verified: 2012-04

Locations

US(1)