NCT01308593

Brief Summary

Investigation into brow aesthetics using Botox in Conjunction with Juvederm XC as evaluated by patient satisfaction

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_4

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

March 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

January 4, 2013

Status Verified

January 1, 2013

Enrollment Period

7 months

First QC Date

March 2, 2011

Last Update Submit

January 3, 2013

Conditions

Brow Ptosis

Outcome Measures

Primary Outcomes (1)

  • Participant satisfaction with combined injection with Botox and Juvederm XC

    5 months

Study Arms (2)

Juvederm XC

ACTIVE COMPARATOR

Juvederm XC

Device: Juvederm XC

Botox

ACTIVE COMPARATOR

Medication used to block neuromuscular transmission

Drug: Botox

Interventions

Juvederm XCDEVICE

Filler

Juvederm XC
BotoxDRUG

26 units dosed one time

Botox

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women

You may not qualify if:

  • Persons who have not had Botox for months.
  • Women who are pregnant, breastfeeding, or trying to get pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skin Care and Laser Physicians of Beverly Hills

Los Angeles, California, 90069, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 2, 2011

First Posted

March 4, 2011

Study Start

March 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

January 4, 2013

Record last verified: 2013-01

Locations

US(1)