NCT02942303

Brief Summary

The purpose of this study is to describe three safe and reproducible techniques for brow lifting using botulinum toxin. It will also describe the effect of 2 techniques on the eyebrow shape using quantitative, objective measurements and satisfaction scales.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 15, 2017

Status Verified

May 1, 2017

Enrollment Period

7 months

First QC Date

October 20, 2016

Last Update Submit

May 11, 2017

Conditions

Brow Lifting

Keywords

Botulinum Toxin, Rejuvenation, Brow lift, Eyebrow.

Outcome Measures

Primary Outcomes (1)

  • Objective assessment

    Objective assessment will be done on anteroposterior views of pre-and-post injection photographs. The mid pupillary line will be drawn and the eyebrow vertical height will be measured from this line to the upper border of the brow at seven horizontal points: the most medial aspect of the eyebrow, medial canthus, medial limbus, mid pupil, lateral limbus, lateral sclera, and most lateral eyebrow.

    15 days post treatment

Secondary Outcomes (1)

  • Patient satisfaction

    15 days post treatment

Study Arms (2)

Technique 1: Lateral orbicularis injections

ACTIVE COMPARATOR

5 equally spaced injections will be placed intramuscularly into the orbicularis under the lateral eyebrow starting lateral to the level of the lateral limbus and extending to the level of the inferior orbital rim.

Drug: DysportProcedure: lateral orbicularis injection

2. Technique 2: Lateral orbicularis and Corrugator injections

ACTIVE COMPARATOR

5 equally spaced injections will be placed intramuscularly into the orbicularis under the lateral eyebrow starting lateral to the level of the lateral limbus and extending to the level of the inferior orbital rim. In addition, 2 injections will be placed into the corrugator at the medial brow

Drug: DysportProcedure: Lateral orbicularis + corrugator injection

Interventions

DysportDRUG
Also known as: abobotulinumtoxineA
2. Technique 2: Lateral orbicularis and Corrugator injectionsTechnique 1: Lateral orbicularis injections
lateral orbicularis injectionPROCEDURE
Technique 1: Lateral orbicularis injections
Lateral orbicularis + corrugator injectionPROCEDURE
2. Technique 2: Lateral orbicularis and Corrugator injections

Eligibility Criteria

Age28 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Consecutive 30 female patients presenting to our clinic for brow lifting with botulinum toxin will be randomized to receive one of the two injection techniques

You may not qualify if:

  • Patients with previous periorbital/forehead surgery
  • Patients who plucked the upper eyebrow margin
  • Patients with eyebrow tatoos
  • Patients with upper face botulinum toxin injection in the past 12 months
  • Patients with resorbable upper face fillers injection in the past 12 months
  • Patients with previous permanent upper face fillers injection
  • Pregnant patients
  • Lactating patients
  • Patients with preexisting neuromuscular conditions (myasthenia gravis, Eaton Lambert syndrome)
  • Patients using medication that could potentiate the effect of botulinum (ex: aminoglycoside antibiotics)
  • Patients with sensitivity to botulinum toxin or human albumin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel Dieu De France

Beirut, Aschrafieh, 00961, Lebanon

RECRUITING

Related Publications (1)

  • El-Khoury JS, Jabbour SF, Awaida CJ, Rayess YA, Kechichian EG, Nasr MW. The Impact of Botulinum Toxin on Brow Height and Morphology: A Randomized Controlled Trial. Plast Reconstr Surg. 2018 Jan;141(1):75-78. doi: 10.1097/PRS.0000000000003919.

    PMID: 29280866DERIVED

MeSH Terms

Interventions

abobotulinumtoxinA

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 20, 2016

First Posted

October 24, 2016

Study Start

October 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 15, 2017

Record last verified: 2017-05

Locations

LE(1)