Study of BOTOX and JUVEDERM for Treatment of Moderate to Severe Facial Wrinkles and Folds (JUVE_BTX)

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
AboutSkin Dermatology, AboutSkin Dermatology and DermSurgery, PC
ClinicalTrials.gov Identifier:
NCT01269801
First received: January 2, 2011
Last updated: December 12, 2014
Last verified: December 2014
Results First Received: July 11, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Wrinkles
Interventions: Drug: onabotulinumtoxinA
Drug: JUVÉDERM

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Subjects were randomized to two groups: Juvederm first, then Botox (Juvederm group) or Botox first, then Juvederm (Botox group).

For the Juvederm group, Day 1 involved juvederm treatment. Week 4 involved botox administration.

For the Botox group, Day 1 involved botox treatment. Week 4 involved juvederm administration.


Reporting Groups
  Description
JUVÉDERM

JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel

Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.

At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment.

Botox Cosmetic

Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.

At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment.


Participant Flow:   Overall Study
    JUVÉDERM     Botox Cosmetic  
STARTED     74     80  
COMPLETED     74     77  
NOT COMPLETED     0     3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline analysis stratified by treatment group (per sequence).

Reporting Groups
  Description
Botox Cosmetic

Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.

At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment.

JUVÉDERM

JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel

Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.

At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment.

Total Total of all reporting groups

Baseline Measures
    Botox Cosmetic     JUVÉDERM     Total  
Number of Participants  
[units: participants]
  80     74     154  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     80     74     154  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  49.83  (7.42)     51.12  (7.78)     50.54  (7.6)  
Gender  
[units: participants]
     
Female     76     66     142  
Male     4     8     12  



  Outcome Measures

1.  Primary:   Efficacy   [ Time Frame: Week 4, 8, 12, 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Joel L. Cohen, MD
Organization: AboutSkin
phone: 303-756-7546
e-mail: research@aboutskinderm.com


No publications provided


Responsible Party: AboutSkin Dermatology, AboutSkin Dermatology and DermSurgery, PC
ClinicalTrials.gov Identifier: NCT01269801     History of Changes
Other Study ID Numbers: JUVE_BTX-09-01
Study First Received: January 2, 2011
Results First Received: July 11, 2014
Last Updated: December 12, 2014
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee
Germany: Ethics Commission