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Brow Enhancement Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Derek H. Jones, M.D., Skin Care and Laser Physicians of Beverly Hills
ClinicalTrials.gov Identifier:
NCT01308593
First received: March 2, 2011
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Brow Ptosis
 Device: Juvederm XC
Drug: Botox
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigation Into Brow Aesthetics Using Botox in Conjunction With Juvederm Ultra XC as Evaluated by Patient Satisfaction

Resource links provided by NLM:

MedlinePlus related topics: Botox
U.S. FDA Resources

Further study details as provided by Skin Care and Laser Physicians of Beverly Hills:

Primary Outcome Measures:
  • Participant satisfaction with combined injection with Botox and Juvederm XC [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: March 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Juvederm XC
Juvederm XC
 Device: Juvederm XC
Filler
Active Comparator: Botox
Medication used to block neuromuscular transmission
 Drug: Botox
26 units dosed one time

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women

Exclusion Criteria:

  • Persons who have not had Botox for months.
  • Women who are pregnant, breastfeeding, or trying to get pregnant.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308593

Locations
United States, California
Skin Care and Laser Physicians of Beverly Hills
Los Angeles, California, United States, 90069
Sponsors and Collaborators
Skin Care and Laser Physicians of Beverly Hills
  More Information

No publications provided

Responsible Party: Derek H. Jones, M.D., Principal Investigator, Skin Care and Laser Physicians of Beverly Hills
ClinicalTrials.gov Identifier: NCT01308593     History of Changes
Other Study ID Numbers: Brow Study 25856/1
Study First Received: March 2, 2011
Last Updated: January 3, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013